These is the information about my upcoming lectures on new HIV treatments, lipodystrophy, superinfection, exercise, and nutrition update in December
Dec 5- San Francisco Gay and Lesbian Center
6:00 dinner, 6: 30 lecture
Free to the public. Limited sitting
No reservations needed
Dec 6- Lifeling AIDS Alliance- Seattle
Seneca Conference Room
6:00 dinner, 6:30 lecture
1102 East Seneca
Reservations : stepreservations@llaa.org
Dec 13- Cumbre Nacional de Educadores de Tratamiento de Habla Hispana- Miami
Dec 14- How to read your blood work- El Paso
For more information, email nelsonvergel@yahoo.com
-
The untold Side of the movie "Dallas Buyers Club"
The movie Dallas Buyers Club brings attention to a little-recognized part of the AIDS activist movement: ....
-
Exhorbitant Price New Hepatitis C Drug
Fair Pricing Coalition Condemns Gilead Sciences on the High Price of New Hepatitis C Drug Sovaldi™...
-
Six Promising HIV Drugs in the Pipeline (2013-2014)
What new HIV medications do we have to look forward to over the next few years? How will these newer drugs improve upon the older ones? To shed some light on these questions....
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What Can We Look Forward to in HIV Cure Research
TheBodyPRO.com's Nelson Vergel sat down with leading HIV cure research activist Richard Jefferys for an update on current important aspects, and controversies, in HIV cure research....
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What Supplements Can I take with HIV medications?
Is it ok to supplement with Creatine (Cell-Tech), and Protein (Nitro-Tech) along with Glutamine...
Friday, November 24, 2006
Thursday, October 19, 2006
Lectures in Philadelphia and NYC- Nov 14 & 15
This is a press release for my upcoming lecture in New York. There will also be one in Philadelphia the day before (NOV 14).
The Philadelphia lecture will be sponsored by Philadelphia Fight and will be held on Tuesday, November 14 at The Church of St. Luke and The Epiphany on 330 South 13th Street (Between Pine and Spruce Streets) from 6 pm – 9 pm. To reserve a seat for the lecture, please email vergel@critpath.org. A light dinner will be provided.
FOR IMMEDIATE RELEASE
CONTACT: Carlos Maldonado212-584-9314
e-mail: cmaldonado@latinoaids.org
The Latino Commission on AIDS to sponsor “Stronger than HIV” in New York on November 15
New York, October 13, 2006 – Nelson Vergel, a 23 –year HIV survivor, international speaker and co-author of “Built To Survive” is visiting New York to provide a patient perspective and comprehensive overview of HIV treatments and side effect management. The free lecture will be held on November 15 at the LGBT Center in New York (208 West 13th Street) from 6 – 9 pm. A light dinner will be provided.
Nelson Vergel , a former chemical engineer and native of Venezuela, has given over 400 seminars in the past 12 years and is the founder of Program for Wellness Restoration (PoWeR), The Body Positive Wellness Clinic in Houston, a member of the AIDS Treatment Activists Coalition and the founder of pozhealth at yahoo.com, the largest HIV health discussion group in the internet. Nelson had failed all commercially available HIV medications in his 23 years of infection and only recently reached undetectable viral load and a dramatic increase in CD4 cells using new research medications. He wants to share his knowledge from a patient perspective to help all patients who have developed multi drug resistance.
“Nelson has been a strong activist who has advocated for faster new drug research and access for people failing HIV therapies”, said Jeff Taylor, a national AIDS treatment activist and long term survivor. “He has a lot of practical knowledge about how to overcome HIV resistance and minimize side effects to live longer and better”, added Taylor.
“We are happy to be able to sponsor this important seminar in New York City”, said Carlos Maldonado, treatment education director at the Latino Commission on AIDS. “Nelson’s lectures are always well attended in our community so we are ready to hear the new exciting news in the management of HIV “, added Maldonado.
For more information on his book or details on the seminars, visit Nelson’s websites at www.nelsonvergel.com, www.medibolics.com and www.powerusa.org or email Nelson at NelsonVergel@yahoo.com. For more information about the seminar, please call 212-584-9314 or e-mail: cmaldonado@latinoaids.org
# # #
The Philadelphia lecture will be sponsored by Philadelphia Fight and will be held on Tuesday, November 14 at The Church of St. Luke and The Epiphany on 330 South 13th Street (Between Pine and Spruce Streets) from 6 pm – 9 pm. To reserve a seat for the lecture, please email vergel@critpath.org. A light dinner will be provided.
FOR IMMEDIATE RELEASE
CONTACT: Carlos Maldonado212-584-9314
e-mail: cmaldonado@latinoaids.org
The Latino Commission on AIDS to sponsor “Stronger than HIV” in New York on November 15
New York, October 13, 2006 – Nelson Vergel, a 23 –year HIV survivor, international speaker and co-author of “Built To Survive” is visiting New York to provide a patient perspective and comprehensive overview of HIV treatments and side effect management. The free lecture will be held on November 15 at the LGBT Center in New York (208 West 13th Street) from 6 – 9 pm. A light dinner will be provided.
Nelson Vergel , a former chemical engineer and native of Venezuela, has given over 400 seminars in the past 12 years and is the founder of Program for Wellness Restoration (PoWeR), The Body Positive Wellness Clinic in Houston, a member of the AIDS Treatment Activists Coalition and the founder of pozhealth at yahoo.com, the largest HIV health discussion group in the internet. Nelson had failed all commercially available HIV medications in his 23 years of infection and only recently reached undetectable viral load and a dramatic increase in CD4 cells using new research medications. He wants to share his knowledge from a patient perspective to help all patients who have developed multi drug resistance.
“Nelson has been a strong activist who has advocated for faster new drug research and access for people failing HIV therapies”, said Jeff Taylor, a national AIDS treatment activist and long term survivor. “He has a lot of practical knowledge about how to overcome HIV resistance and minimize side effects to live longer and better”, added Taylor.
“We are happy to be able to sponsor this important seminar in New York City”, said Carlos Maldonado, treatment education director at the Latino Commission on AIDS. “Nelson’s lectures are always well attended in our community so we are ready to hear the new exciting news in the management of HIV “, added Maldonado.
For more information on his book or details on the seminars, visit Nelson’s websites at www.nelsonvergel.com, www.medibolics.com and www.powerusa.org or email Nelson at NelsonVergel@yahoo.com. For more information about the seminar, please call 212-584-9314 or e-mail: cmaldonado@latinoaids.org
# # #
Sunday, October 08, 2006
Chipmunk Cheeks and Bullfrog Neck
Banishing Chipmunk Cheeks and Bullfrog Neck
Treating these and other body changes from HIV drugs
by Enid Vázquez - Test Positive Aware
--------------------------------------------------------------------------------
Some people experienced facial wasting as a result of HIV treatment, others got a fat face. Nelson Vergel had the swollen glands on the side of his face that made it look bigger.
Vergel, a treatment activist who started as an advocate of exercise and anabolic steroids to treat loss of lean body mass in people with HIV, lectures all over the world on how to live well with the virus. Still, he found nothing by the way of research discussing the problem of inflamed parotid glands in HIV. Then he got a call from a friend in Los Angeles, Dr. Tony Mills. Mills found a local cancer doctor successfully treating the condition.
Vergel sought the radiation treatment from Dr. Patricia Gordon and raved about the results on his blog, http://survivinghiv.blogspot.com. “It’s been four years now (as of March 2006) and they are still normal! I had no significant side effects besides redness for a few days, no beard for a month (which I liked), and a temporary loss of normal saliva production. All returned to normal after a month or so.” He thought that a temporary small dip in his T-cells also resulted from the treatment, but couldn’t be sure.
The chipmunk cheeks, the bullfrog neck, the buffalo hump, the protease paunch—there are treatments for these distressing body changes brought on by HIV medications. That doesn’t mean that getting back to where you started is easy. It does mean that options exist.
Chipmunk Cheeks
Minutes after I e-mail Dr. Gordon about her amazing work with HIV patients experiencing facial abnormalities, she calls me. That’s a dedicated doctor.
“My patients are always looking for ways to get the word out,” she tells me.
“I treat lung, prostate, and breast cancer, but my passion is HIV,” Gordon continues. Treating 1,500 AIDS patients with Kaposi’s sarcoma (KS) during the late ’80s was tremendously satisfying for her. Parotid enlargement is not cancer,” she says, “but low doses of radiation have been highly successful in eliminating the swelling, getting rid of the chipmunk look and restoring the normal angle of the jaw line.”
“Kaposi’s sarcoma went away with antiviral therapy, and then we saw the horrible side effects of lipodystrophy,” Gordon explains about her new HIV work. “Lipodystrophy” refers to body fat abnormalities related to HIV medications, as well as metabolic complications such as elevated cholesterol.
"These cheeks can become massive."
She provides several treatments of low-dose radiation, over three weeks, to shrink the glands back to normal, and says she’s had no trouble getting reimbursement from Medicaid and private insurance. That’s because “it’s painful,” she says of the condition. “These cheeks can become massive. Some of these guys are so grateful they cry. Some wouldn’t go out of the house because it was so grotesque looking.” The treatment “greatly reduces, and in most cases, eliminates, the swelling,” she says of the 400-plus HIV patients she has treated. She can be reached at 1-310-201-6739 or 1-310-659-6770. Her clinic has a hotel rate for patients.
Bullfrog Neck
I recently saw a prominent woman with HIV, a motivational speaker, still slim and beautiful after all these years. But on her neck, directly under her face, there was about five or 10 pounds of fat, so large and abnormal that anyone seeing her would know something was wrong.
“I can fix that,” says plastic surgeon Dr. Joseph Romano, whose clinic is in San Francisco. Vergel refers people to Romano: “He’s doing great work. He uses ultrasound-assisted liposuction, so that the ultrasound breaks down the fat before liposuctioning it out. It goes down with weight loss, but some people need liposuction.”
Romano can be reached at 1-415-981-3911 or via his Website, www.jromano.com. Remember that plastic surgery is expensive, and not covered by insurance, unless it can be tied to pain-related issues or sleep apnea.
Facial Wasting
“I see someone with sunken cheeks,” says Vergel, “and I just want to talk to them: ‘Listen, there’s a patient assistance program [for Sculptra]—you don’t even have to pay for it. I can show you how.’” Vergel says his lectures and Internet work makes it easy for him to talk about Sculptra treatments because it allows people to come to him. Vergel’s Website is www.powerusa.org.
Also see back issues of Positively Aware for personal stories of surgery for facial wasting. The November/December 2004 issue covers Bio-Alcamid, available in a Tijuana clinic with a large number of HIV patients, for both facial wasting and buttock enhancement—look for an upcoming article on the latter. Call 1-619-298-0657 or visit www.clinicestetica.com. It is also now available in Canada; visit www.facialwasting.org. The May/June 2002 issue has a story on Sculptra.
Protease Paunch
Vergel swears that the so-called “protease paunch” associated with antiviral therapy can be reversed, but few people can do what it takes: diet and exercise.
“First, improve your insulin sensitivity by choosing only low-glycemic index carbs (like oatmeal, fruits, and vegetables),” he says. “Lower your simple carbs. White is bad, color is good—it’s not a racist thing!” jokes Vergel, who’s from Venezuela. “No sugar, no white flour, no pasta, no tortillas, no chips. Lots of lean meats, nuts, eggs, low-fat cheese. Don’t drink soda pop, just water. Watch bottled juice—some have more sugar than pop. I think all these problems are sugar related. Dr. [Donald] Kotler showed that visceral obesity [the enlarged belly] is associated with glucose intolerance, and that many people with normal blood sugar have metabolic symptoms years before it shows up in the blood.” [See Vergel’s interview with Dr. Kotler at www.nelsonvergel.com.]
Vergel points out that a fasting blood sugar test is very different from a glucose tolerance test. The glucose tolerance test is simple, but very inconvenient. It consists of giving someone a glucose solution to drink and then having them sit around for hours waiting to be tested for their blood glucose response to see if there is glucose intolerance. Said one prominent HIV specialist, “Patients hate taking the test, and we hate giving it.”
For those people with both obesity and severe glucose intolerance, the use of metformin (Glucophage), says Vergel, has been shown in a small study to decrease belly fat, especially if used along with cardiovascular exercise. Other insulin sensitizers like Actos [pioglitazone] and Azandia [rosiglitazone] don’t seem to work as well in reducing belly fat, he says.
A low-carb diet would “shed all that fat” (although he’s not a fan of the Atkins diet), but people find it hard to stay on them, Vergel continues.
Liposuction cannot be used for protease paunch—what in other groups of people, such as alcoholics or diabetics, is called metabolic syndrome or Syndrome X—because the fat lies internally, directly on the organs. This type of belly tends to be hard, not blubbery.
Vergel talked about a Tufts University study showing that in HIV-positive people, those with a higher intake of soluble fiber (fruits and vegetables) had a trend towards lower incidence of lipodystrophy-related abdominal fat, and so did the ones who exercised. “This makes sense,” says Vergel, “since soluble fiber slows down the absorption of glucose into the blood stream and may give insulin a better chance to work properly. Exercise also makes insulin work better to help the body use glucose for energy. I tell people, if you can’t do anything else, walk everywhere you can, avoid processed sweets and starches, and eat more fruits and vegetables. It is interesting to me that I see less obesity among the people in New York and in European cities—they walk everywhere.
“We’re not eating enough soluble fiber or exercising, and the PIs [protease inhibitor HIV medications] make it much worse, and we’re all aging,” Vergel concluded.
Internet Resources
--------------------------------------------------------------------------------
www.thebody.com/metabolism/contents.html
www.medibolics.com
Losing the fat, in brief
--------------------------------------------------------------------------------
The editors of AIDS Treatment Update, in London, put together these weight loss tips from Nelson Vergel in their December 2005 issue. Visit www.aidsmap.com.
Cut calories and fill yourself up with fruits, vegetables, grains, and lean meats. Eat small frequent meals.
Exercise with weights/machines 3–4 times a week for an hour, and also do cardiovascular exercise (fast walking, light jogging, etc.) for at least 30 minutes a day after weight training. Make sure that you sweat!
Ask you doctor to check your hormone levels and your thyroid function since low levels of testosterone or thyroxin can make you prone to gaining more fat.
Get your lipids and blood sugar under control with a healthy diet, regular exercise, and medicines if necessary.
Beware of companies that claim their weight loss/appetite suppressant supplements or “growth hormone precursors” work. They don’t. Most weight loss supplements have stimulants that can affect mood and increase blood pressure and cardiovascular risks.
Main Positively Aware Page:
Positively Aware
Treating these and other body changes from HIV drugs
by Enid Vázquez - Test Positive Aware
--------------------------------------------------------------------------------
Some people experienced facial wasting as a result of HIV treatment, others got a fat face. Nelson Vergel had the swollen glands on the side of his face that made it look bigger.
Vergel, a treatment activist who started as an advocate of exercise and anabolic steroids to treat loss of lean body mass in people with HIV, lectures all over the world on how to live well with the virus. Still, he found nothing by the way of research discussing the problem of inflamed parotid glands in HIV. Then he got a call from a friend in Los Angeles, Dr. Tony Mills. Mills found a local cancer doctor successfully treating the condition.
Vergel sought the radiation treatment from Dr. Patricia Gordon and raved about the results on his blog, http://survivinghiv.blogspot.com. “It’s been four years now (as of March 2006) and they are still normal! I had no significant side effects besides redness for a few days, no beard for a month (which I liked), and a temporary loss of normal saliva production. All returned to normal after a month or so.” He thought that a temporary small dip in his T-cells also resulted from the treatment, but couldn’t be sure.
The chipmunk cheeks, the bullfrog neck, the buffalo hump, the protease paunch—there are treatments for these distressing body changes brought on by HIV medications. That doesn’t mean that getting back to where you started is easy. It does mean that options exist.
Chipmunk Cheeks
Minutes after I e-mail Dr. Gordon about her amazing work with HIV patients experiencing facial abnormalities, she calls me. That’s a dedicated doctor.
“My patients are always looking for ways to get the word out,” she tells me.
“I treat lung, prostate, and breast cancer, but my passion is HIV,” Gordon continues. Treating 1,500 AIDS patients with Kaposi’s sarcoma (KS) during the late ’80s was tremendously satisfying for her. Parotid enlargement is not cancer,” she says, “but low doses of radiation have been highly successful in eliminating the swelling, getting rid of the chipmunk look and restoring the normal angle of the jaw line.”
“Kaposi’s sarcoma went away with antiviral therapy, and then we saw the horrible side effects of lipodystrophy,” Gordon explains about her new HIV work. “Lipodystrophy” refers to body fat abnormalities related to HIV medications, as well as metabolic complications such as elevated cholesterol.
"These cheeks can become massive."
She provides several treatments of low-dose radiation, over three weeks, to shrink the glands back to normal, and says she’s had no trouble getting reimbursement from Medicaid and private insurance. That’s because “it’s painful,” she says of the condition. “These cheeks can become massive. Some of these guys are so grateful they cry. Some wouldn’t go out of the house because it was so grotesque looking.” The treatment “greatly reduces, and in most cases, eliminates, the swelling,” she says of the 400-plus HIV patients she has treated. She can be reached at 1-310-201-6739 or 1-310-659-6770. Her clinic has a hotel rate for patients.
Bullfrog Neck
I recently saw a prominent woman with HIV, a motivational speaker, still slim and beautiful after all these years. But on her neck, directly under her face, there was about five or 10 pounds of fat, so large and abnormal that anyone seeing her would know something was wrong.
“I can fix that,” says plastic surgeon Dr. Joseph Romano, whose clinic is in San Francisco. Vergel refers people to Romano: “He’s doing great work. He uses ultrasound-assisted liposuction, so that the ultrasound breaks down the fat before liposuctioning it out. It goes down with weight loss, but some people need liposuction.”
Romano can be reached at 1-415-981-3911 or via his Website, www.jromano.com. Remember that plastic surgery is expensive, and not covered by insurance, unless it can be tied to pain-related issues or sleep apnea.
Facial Wasting
“I see someone with sunken cheeks,” says Vergel, “and I just want to talk to them: ‘Listen, there’s a patient assistance program [for Sculptra]—you don’t even have to pay for it. I can show you how.’” Vergel says his lectures and Internet work makes it easy for him to talk about Sculptra treatments because it allows people to come to him. Vergel’s Website is www.powerusa.org.
Also see back issues of Positively Aware for personal stories of surgery for facial wasting. The November/December 2004 issue covers Bio-Alcamid, available in a Tijuana clinic with a large number of HIV patients, for both facial wasting and buttock enhancement—look for an upcoming article on the latter. Call 1-619-298-0657 or visit www.clinicestetica.com. It is also now available in Canada; visit www.facialwasting.org. The May/June 2002 issue has a story on Sculptra.
Protease Paunch
Vergel swears that the so-called “protease paunch” associated with antiviral therapy can be reversed, but few people can do what it takes: diet and exercise.
“First, improve your insulin sensitivity by choosing only low-glycemic index carbs (like oatmeal, fruits, and vegetables),” he says. “Lower your simple carbs. White is bad, color is good—it’s not a racist thing!” jokes Vergel, who’s from Venezuela. “No sugar, no white flour, no pasta, no tortillas, no chips. Lots of lean meats, nuts, eggs, low-fat cheese. Don’t drink soda pop, just water. Watch bottled juice—some have more sugar than pop. I think all these problems are sugar related. Dr. [Donald] Kotler showed that visceral obesity [the enlarged belly] is associated with glucose intolerance, and that many people with normal blood sugar have metabolic symptoms years before it shows up in the blood.” [See Vergel’s interview with Dr. Kotler at www.nelsonvergel.com.]
Vergel points out that a fasting blood sugar test is very different from a glucose tolerance test. The glucose tolerance test is simple, but very inconvenient. It consists of giving someone a glucose solution to drink and then having them sit around for hours waiting to be tested for their blood glucose response to see if there is glucose intolerance. Said one prominent HIV specialist, “Patients hate taking the test, and we hate giving it.”
For those people with both obesity and severe glucose intolerance, the use of metformin (Glucophage), says Vergel, has been shown in a small study to decrease belly fat, especially if used along with cardiovascular exercise. Other insulin sensitizers like Actos [pioglitazone] and Azandia [rosiglitazone] don’t seem to work as well in reducing belly fat, he says.
A low-carb diet would “shed all that fat” (although he’s not a fan of the Atkins diet), but people find it hard to stay on them, Vergel continues.
Liposuction cannot be used for protease paunch—what in other groups of people, such as alcoholics or diabetics, is called metabolic syndrome or Syndrome X—because the fat lies internally, directly on the organs. This type of belly tends to be hard, not blubbery.
Vergel talked about a Tufts University study showing that in HIV-positive people, those with a higher intake of soluble fiber (fruits and vegetables) had a trend towards lower incidence of lipodystrophy-related abdominal fat, and so did the ones who exercised. “This makes sense,” says Vergel, “since soluble fiber slows down the absorption of glucose into the blood stream and may give insulin a better chance to work properly. Exercise also makes insulin work better to help the body use glucose for energy. I tell people, if you can’t do anything else, walk everywhere you can, avoid processed sweets and starches, and eat more fruits and vegetables. It is interesting to me that I see less obesity among the people in New York and in European cities—they walk everywhere.
“We’re not eating enough soluble fiber or exercising, and the PIs [protease inhibitor HIV medications] make it much worse, and we’re all aging,” Vergel concluded.
Internet Resources
--------------------------------------------------------------------------------
www.thebody.com/metabolism/contents.html
www.medibolics.com
Losing the fat, in brief
--------------------------------------------------------------------------------
The editors of AIDS Treatment Update, in London, put together these weight loss tips from Nelson Vergel in their December 2005 issue. Visit www.aidsmap.com.
Cut calories and fill yourself up with fruits, vegetables, grains, and lean meats. Eat small frequent meals.
Exercise with weights/machines 3–4 times a week for an hour, and also do cardiovascular exercise (fast walking, light jogging, etc.) for at least 30 minutes a day after weight training. Make sure that you sweat!
Ask you doctor to check your hormone levels and your thyroid function since low levels of testosterone or thyroxin can make you prone to gaining more fat.
Get your lipids and blood sugar under control with a healthy diet, regular exercise, and medicines if necessary.
Beware of companies that claim their weight loss/appetite suppressant supplements or “growth hormone precursors” work. They don’t. Most weight loss supplements have stimulants that can affect mood and increase blood pressure and cardiovascular risks.
Main Positively Aware Page:
Positively Aware
Saturday, September 09, 2006
MRK 518, an integrase inhibitor, available now
This new drug , first in the new integrase class, is now available via an expanded access program(EAP). If you have resistance to three drug classes, have your doctor fill out the form at the bottom on this page to request to be part of this EAP. Patients should not contact Merck for access.
http://benchmrk.com/secure/earmrk/earmrk.html
You should start this drug with another drug to which your HIV virus has not developed resistance. Examples are Prezista, Fuzeon, Aptivus, etc, plus a background of nucleoside inhibitors (Viread, Ziagen, Epivir, Emtriva, etc)
TMC 125 , a non nuke also available via expanded access now from Tibotec, cannot be used right now with MRK 518 until Merck finishes interaction studies to see if it is OK to combine these two drugs. So far, it seems that MRK 518 plays well with other HIV and OI drugs with no dose adjustments due to interactions.
http://benchmrk.com/secure/earmrk/earmrk.html
You should start this drug with another drug to which your HIV virus has not developed resistance. Examples are Prezista, Fuzeon, Aptivus, etc, plus a background of nucleoside inhibitors (Viread, Ziagen, Epivir, Emtriva, etc)
TMC 125 , a non nuke also available via expanded access now from Tibotec, cannot be used right now with MRK 518 until Merck finishes interaction studies to see if it is OK to combine these two drugs. So far, it seems that MRK 518 plays well with other HIV and OI drugs with no dose adjustments due to interactions.
Thursday, August 31, 2006
New Option for HIV related Facial Lipoatrophy to be approved soon in the US
I had a call with Bioform, the makers of Radiesse yesterday. I am organizing a group of treatment activists to meet with them to discuss their patient assistance program design soon. We still do not know what the cost for HIV related work will be or what the patient assistance program will look like. I am hoping that they will be as easy to work with as Dermik (Sculptra) was.
From FACIALWASTING.ORG:
Radiesse (also called Radiense) is (calcium hydroxylapatite, (CaHA) microspheres suspended in an aqueous polysaccharide gel. Radiance, the newest product in the market, is not approved in the US as a facial filler yet but doctors are using it under an IDE study. It is manufactured by Bioform of Franksville, Wisconsin. In general, calcium hydroxylapatite has safely been used in the body for many applications including dental applications where bone build-up is needed for reconstruction and also in block form for cosmetic applications such as cheek, jaw, cranial and chin implants (hard bony areas). Calcium hydroxylapatite creates a lattice where the surrounding cells can be incorporated from ossification in bony areas to a stable scaffold in which soft tissue can grow. The calcium hydroxylapatite microspheres are suspended in a polysaccharide carrier which holds the microspheres in place until it is resorbed and the collagenation takes place. When injected in soft tissue, away from bone, fibroblasts work by building reportedly a non-scar tissue collagen type, thus creating volume in the treatment area. Its unclear where this material should be injected (dermally or sub dermally) to achieve correction of facial defects. It is being used in small quatities for wrinkle treatment and lip augmentation. It tends to be unforgiving if not applied properly. An allergy test is supposedly not needed. The especulated longevity is 2 to 5 years .
More about a study here: http://dermatology.cdlib.org/102/therapy/HIV/comite.html
INFORMATION FROM THE COMPANY:
*************************************************
RADIESSE® FACT SHEET
WHAT IS RADIESSE
Radiesse is a next-generation, long-lasting product used for soft tissue augmentation.
· Radiesse consists of calcium-based microsphere technology that naturally promotes the growth of a patient’s own collagen.
· Radiesse provides a correction that has been proven to last one year without surgery.
· Radiesse is not permanent and therefore avoids the risks associated with permanent materials.
HOW IT WORKS
Radiesse is an injectable product consisting of tiny calcium-based particles that replace volume loss and also stimulate new collagen growth for long-lasting clinical results.
· Radiesse is gently injected into the skin in very small amounts with a very fine needle. Its exclusive calcium-based microsphere technology contains tiny particles of calcium-based powder that form a scaffold around which the body produces new collagen to naturally restore the fullness and contours of the face. The tiny microspheres gradually break down into calcium and phosphate ions that are naturally absorbed by the body over time.
· Radiesse’s biocompatible composition is harmonious with the body and poses virtually no risk of an allergic reaction.
WHAT IT TREATS
Radiesse is a long-lasting soft tissue augmentation material used to correct facial wrinkles and folds, such as nasolabial folds. It also used to correct facial lipoatrophy (facial wasting) associated with HIV therapy.
WHAT SETS RADIESSE APART
Radiesse is different because it is a next-generation product that is long-lasting.
THE PROOF:
Years of rigorous clinical testing and use by physicians in more than 200,000 patients worldwide demonstrate that Radiesse is safe and effective. Further, clinical studies show that the average Radiesse treatment lasts one year.
WHO STANDS BY RADIESSE:
BioForm Medical is a privately-held medical device company that develops and commercializes injectable implants for soft tissue augmentation.
ML00179-00
********************************************
Radiesse® 12-Month HIV Facial Lipoatrophy
CLINICAL study BACKGROUNDER
Trial Background:
o A multi-site, clinical study examining the safety and efficacy of Radiesse injections for restorative treatment of HIV-associated facial lipoatrophy.
o Conducted by BioForm Medical, Inc., a privately-held medical device company specializing in injectable products for soft tissue augmentation.
o Trial conducted under an Investigational Device Exemption (IDE) granted by the FDA.
Trial Design:
o Conducted at three medical centers in the United States, including two centers in New York City and one in San Francisco.
o 100 patients with HIV-associated facial lipoatrophy were enrolled in the trial.
o All study patients received an injection of Radiesse during initial visit and were seen one month later for touch up injections as necessary.
o Additional follow up conducted at three and six months.
Key Findings:
o Patients were scored by their physician for improved appearance on the Global Aesthetic Improvement Scale (GAIS). Finding 12 months after treatment with Radiesse showed:
· 32 percent of patients’ appearance were Very Much Improved
· 52 percent of patients’ appearance were Much Improved
· 16 percent of patients’ appearance were Improved
· 0 percent of patients’ appearance was Unchanged
· 0 percent of patients’ appearance was Worse
o During the study, patients were asked how treatment with Radiesse had affected their quality of life. At 12-months follow up:
· 100 percent of patients said that treatment with Radiesse had been beneficial
· 99 percent of patients said they were more confident about their appearance after treatment with Radiesse
· 99 percent of patients said they would recommend treatment with Radiesse
· 98 percent of patients said that they felt more attractive after treatment with Radiesse
· 97percent of patients said that they felt their emotional state had improved after treatment with Radiesse
o Radiesse was safe and well tolerated, with no serious device-related adverse events reported. In all 100 patients, Radiesse was proven safe for injection.
Data Publication/ Presentation:
Study results were presented at the recent meetings of the American Society of Plastic Surgery (ASPS) and American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS).
Findings were published in a special supplement of the September 2005 issue of Plastic Surgery Journal.
Current Indications:
Radiesse is currently approved in the U.S. for treatment of the following conditions:
Oral/Maxillofacial Defects
Vocal Fold Insufficiency
Radiographic Tissue Marking
From FACIALWASTING.ORG:
Radiesse (also called Radiense) is (calcium hydroxylapatite, (CaHA) microspheres suspended in an aqueous polysaccharide gel. Radiance, the newest product in the market, is not approved in the US as a facial filler yet but doctors are using it under an IDE study. It is manufactured by Bioform of Franksville, Wisconsin. In general, calcium hydroxylapatite has safely been used in the body for many applications including dental applications where bone build-up is needed for reconstruction and also in block form for cosmetic applications such as cheek, jaw, cranial and chin implants (hard bony areas). Calcium hydroxylapatite creates a lattice where the surrounding cells can be incorporated from ossification in bony areas to a stable scaffold in which soft tissue can grow. The calcium hydroxylapatite microspheres are suspended in a polysaccharide carrier which holds the microspheres in place until it is resorbed and the collagenation takes place. When injected in soft tissue, away from bone, fibroblasts work by building reportedly a non-scar tissue collagen type, thus creating volume in the treatment area. Its unclear where this material should be injected (dermally or sub dermally) to achieve correction of facial defects. It is being used in small quatities for wrinkle treatment and lip augmentation. It tends to be unforgiving if not applied properly. An allergy test is supposedly not needed. The especulated longevity is 2 to 5 years .
More about a study here: http://dermatology.cdlib.org/102/therapy/HIV/comite.html
INFORMATION FROM THE COMPANY:
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RADIESSE® FACT SHEET
WHAT IS RADIESSE
Radiesse is a next-generation, long-lasting product used for soft tissue augmentation.
· Radiesse consists of calcium-based microsphere technology that naturally promotes the growth of a patient’s own collagen.
· Radiesse provides a correction that has been proven to last one year without surgery.
· Radiesse is not permanent and therefore avoids the risks associated with permanent materials.
HOW IT WORKS
Radiesse is an injectable product consisting of tiny calcium-based particles that replace volume loss and also stimulate new collagen growth for long-lasting clinical results.
· Radiesse is gently injected into the skin in very small amounts with a very fine needle. Its exclusive calcium-based microsphere technology contains tiny particles of calcium-based powder that form a scaffold around which the body produces new collagen to naturally restore the fullness and contours of the face. The tiny microspheres gradually break down into calcium and phosphate ions that are naturally absorbed by the body over time.
· Radiesse’s biocompatible composition is harmonious with the body and poses virtually no risk of an allergic reaction.
WHAT IT TREATS
Radiesse is a long-lasting soft tissue augmentation material used to correct facial wrinkles and folds, such as nasolabial folds. It also used to correct facial lipoatrophy (facial wasting) associated with HIV therapy.
WHAT SETS RADIESSE APART
Radiesse is different because it is a next-generation product that is long-lasting.
THE PROOF:
Years of rigorous clinical testing and use by physicians in more than 200,000 patients worldwide demonstrate that Radiesse is safe and effective. Further, clinical studies show that the average Radiesse treatment lasts one year.
WHO STANDS BY RADIESSE:
BioForm Medical is a privately-held medical device company that develops and commercializes injectable implants for soft tissue augmentation.
ML00179-00
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Radiesse® 12-Month HIV Facial Lipoatrophy
CLINICAL study BACKGROUNDER
Trial Background:
o A multi-site, clinical study examining the safety and efficacy of Radiesse injections for restorative treatment of HIV-associated facial lipoatrophy.
o Conducted by BioForm Medical, Inc., a privately-held medical device company specializing in injectable products for soft tissue augmentation.
o Trial conducted under an Investigational Device Exemption (IDE) granted by the FDA.
Trial Design:
o Conducted at three medical centers in the United States, including two centers in New York City and one in San Francisco.
o 100 patients with HIV-associated facial lipoatrophy were enrolled in the trial.
o All study patients received an injection of Radiesse during initial visit and were seen one month later for touch up injections as necessary.
o Additional follow up conducted at three and six months.
Key Findings:
o Patients were scored by their physician for improved appearance on the Global Aesthetic Improvement Scale (GAIS). Finding 12 months after treatment with Radiesse showed:
· 32 percent of patients’ appearance were Very Much Improved
· 52 percent of patients’ appearance were Much Improved
· 16 percent of patients’ appearance were Improved
· 0 percent of patients’ appearance was Unchanged
· 0 percent of patients’ appearance was Worse
o During the study, patients were asked how treatment with Radiesse had affected their quality of life. At 12-months follow up:
· 100 percent of patients said that treatment with Radiesse had been beneficial
· 99 percent of patients said they were more confident about their appearance after treatment with Radiesse
· 99 percent of patients said they would recommend treatment with Radiesse
· 98 percent of patients said that they felt more attractive after treatment with Radiesse
· 97percent of patients said that they felt their emotional state had improved after treatment with Radiesse
o Radiesse was safe and well tolerated, with no serious device-related adverse events reported. In all 100 patients, Radiesse was proven safe for injection.
Data Publication/ Presentation:
Study results were presented at the recent meetings of the American Society of Plastic Surgery (ASPS) and American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS).
Findings were published in a special supplement of the September 2005 issue of Plastic Surgery Journal.
Current Indications:
Radiesse is currently approved in the U.S. for treatment of the following conditions:
Oral/Maxillofacial Defects
Vocal Fold Insufficiency
Radiographic Tissue Marking
Thursday, August 17, 2006
Good News for People in Salvage Therapy: Merck to start its expanded access program for its integrase inhibitor MRK 518
I am very excited about this expanded access of Merck's integrase inhibitor, MRK 518.
I have been taking it for 3 months now with the new protease (Prezista) and have been able to reach undetectable viral load for the first time in 23 years. My CD4 cells have more than doubled from 180 to 440 cells/ml
The response to MRK 518 seems to be faster than most drugs in the past. In a naive study presented this week in Toronto that compared MRK 518 plus Truvada with Sustiva+Truvada, it was seen that MRK 518 can drive viral load down faster than Sustiva, although the Sustiva arm eventually matched the MRK 518 arm at week 24.
So far, no significant side effects have been observed besides an increased in flatulence in some patients.
MRK 518 is taken in one pill twice a day without Norvir ( no need for Norvir boosting is welcomed by many of us!). It seems that it does not have problematic interactions with most drugs since it is not metabolized in the P450 cytochrome in the liver.
I think MRK 518 will be an excellent drug in combination with Prezista and/or Fuzeon for those of us who have run out of options. It may present the first chance for many of us to have undetectable viral load.
NATAP http://natap.org/
_______________________________________________
Expanded Access Program for MK-0518, an Investigational HIV Integrase Inhibitor, Established for Patients with Limited Available Treatment Options
Worldwide Access Program Will Be Conducted Along With Phase III Studies
TORONTO, Aug. 17, 2006 -- A worldwide expanded access program for HIV/AIDS patients with limited or no treatment options was announced today by Merck & Co., Inc., Whitehouse Station, N.J., U.S.A., with respect to its investigational HIV integrase inhibitor, MK-0518, now in Phase III development. Program enrollment will begin in the next few months, pending regulatory review and approvals.
“Making MK-0518 available to those who would like access to this investigational drug but who are unable to participate in the clinical studies underscores our commitment to patients,” said Dr. Peter S. Kim, president, Merck Research Laboratories (MRL).
MK-0518 belongs to a new class of investigational antiretroviral therapy (ART) agents called integrase inhibitors that inhibit the insertion of the HIV viral DNA into human DNA. Integrase is one of three HIV enzymes - reverse transcriptase, protease and integrase - required by the virus to reproduce. Drugs are available that inhibit the functions of the protease and reverse transcriptase enzymes but, to date, there are no approved drugs that target the integration stage of the HIV-1 lifecycle.
Expanded access
“The MK-0518 program is another example of Merck's dedication to people living with HIV/AIDS around the world,” commented Dr. Randi Leavitt, senior director, Infectious Diseases - Clinical Research, MRL and lead coordinator of the expanded access program. “This makes the third expanded access program that Merck has initiated. In mid and late 1990, the Company implemented expanded access programs for two other investigational drugs for treatment of HIV,” Dr. Leavitt explained.
Expanded access is a mechanism supported by regulatory agencies for getting investigational treatment to patients who have a life threatening disease and who cannot be satisfactorily treated with an alternative therapy or available drug. Expanded access programs are not required by regulatory agencies. These
programs are initiated and supported by drug manufacturers in recognition of the promise an unapproved drug may hold for patients facing a life-threatening disease.
MK-0518 expanded access study design
The expanded access program with MK-0518 is a non-comparative, multi-center, open-label, voluntary treatment use study. Investigators will follow patients according to standard of care. The study will continue until approximately three months after MK-0518 has been launched in the local market.
To be eligible to participate, patients must have documented HIV-1 infection, be at least 16 years old, have limited or no treatment options available to them due to resistance or intolerance to multiple anti-retroviral regimens, are not achieving adequate virologic suppression on current regimen and be at risk of clinical or immunologic progression, and be clinically stable. Patients are excluded from the study if they have received MK-0518 in a clinical trial, require any medications prohibited by the protocol, have acute hepatitis due to any cause or clinically significant chronic liver disease, have a condition which the investigator deems will interfere with adherence and safety, or are pregnant.
Patients will receive open-label MK-0518 400 mg twice daily, in addition to optimized background therapy (OBT). Investigators will select the OBT based on the patient's prior treatment history and anti-retroviral resistance testing. OBT will not be provided by Merck. Safety and tolerability of MK-0518 will be monitored.
The program will be managed by a clinical research organization (CRO). The CRO will collect all case report information including serious adverse events and drug-related adverse events that result in Grade 3 or above laboratory toxicity, leading to treatment interruption or discontinuation. No efficacy data will be collected.
About Merck's HIV/AIDS research program
Merck's HIV clinical research program began in 1985. Merck scientists were among the first to discover and develop medicines for the treatment of HIV/AIDS. In 1996, Merck introduced a protease inhibitor, which was followed by the introduction in 1999 of a non-nucleoside reverse transcriptase inhibitor (NNRTI).
In addition to MK-0518, Merck is focused on developing new treatments for millions of individuals who are already infected with HIV, as well as on preventing HIV transmission through the development of a vaccine. Merck also licensed a compound to the International Partnership for Microbicides (IPM) for development as a possible means of preventing HIV infection in women.
I have been taking it for 3 months now with the new protease (Prezista) and have been able to reach undetectable viral load for the first time in 23 years. My CD4 cells have more than doubled from 180 to 440 cells/ml
The response to MRK 518 seems to be faster than most drugs in the past. In a naive study presented this week in Toronto that compared MRK 518 plus Truvada with Sustiva+Truvada, it was seen that MRK 518 can drive viral load down faster than Sustiva, although the Sustiva arm eventually matched the MRK 518 arm at week 24.
So far, no significant side effects have been observed besides an increased in flatulence in some patients.
MRK 518 is taken in one pill twice a day without Norvir ( no need for Norvir boosting is welcomed by many of us!). It seems that it does not have problematic interactions with most drugs since it is not metabolized in the P450 cytochrome in the liver.
I think MRK 518 will be an excellent drug in combination with Prezista and/or Fuzeon for those of us who have run out of options. It may present the first chance for many of us to have undetectable viral load.
NATAP http://natap.org/
_______________________________________________
Expanded Access Program for MK-0518, an Investigational HIV Integrase Inhibitor, Established for Patients with Limited Available Treatment Options
Worldwide Access Program Will Be Conducted Along With Phase III Studies
TORONTO, Aug. 17, 2006 -- A worldwide expanded access program for HIV/AIDS patients with limited or no treatment options was announced today by Merck & Co., Inc., Whitehouse Station, N.J., U.S.A., with respect to its investigational HIV integrase inhibitor, MK-0518, now in Phase III development. Program enrollment will begin in the next few months, pending regulatory review and approvals.
“Making MK-0518 available to those who would like access to this investigational drug but who are unable to participate in the clinical studies underscores our commitment to patients,” said Dr. Peter S. Kim, president, Merck Research Laboratories (MRL).
MK-0518 belongs to a new class of investigational antiretroviral therapy (ART) agents called integrase inhibitors that inhibit the insertion of the HIV viral DNA into human DNA. Integrase is one of three HIV enzymes - reverse transcriptase, protease and integrase - required by the virus to reproduce. Drugs are available that inhibit the functions of the protease and reverse transcriptase enzymes but, to date, there are no approved drugs that target the integration stage of the HIV-1 lifecycle.
Expanded access
“The MK-0518 program is another example of Merck's dedication to people living with HIV/AIDS around the world,” commented Dr. Randi Leavitt, senior director, Infectious Diseases - Clinical Research, MRL and lead coordinator of the expanded access program. “This makes the third expanded access program that Merck has initiated. In mid and late 1990, the Company implemented expanded access programs for two other investigational drugs for treatment of HIV,” Dr. Leavitt explained.
Expanded access is a mechanism supported by regulatory agencies for getting investigational treatment to patients who have a life threatening disease and who cannot be satisfactorily treated with an alternative therapy or available drug. Expanded access programs are not required by regulatory agencies. These
programs are initiated and supported by drug manufacturers in recognition of the promise an unapproved drug may hold for patients facing a life-threatening disease.
MK-0518 expanded access study design
The expanded access program with MK-0518 is a non-comparative, multi-center, open-label, voluntary treatment use study. Investigators will follow patients according to standard of care. The study will continue until approximately three months after MK-0518 has been launched in the local market.
To be eligible to participate, patients must have documented HIV-1 infection, be at least 16 years old, have limited or no treatment options available to them due to resistance or intolerance to multiple anti-retroviral regimens, are not achieving adequate virologic suppression on current regimen and be at risk of clinical or immunologic progression, and be clinically stable. Patients are excluded from the study if they have received MK-0518 in a clinical trial, require any medications prohibited by the protocol, have acute hepatitis due to any cause or clinically significant chronic liver disease, have a condition which the investigator deems will interfere with adherence and safety, or are pregnant.
Patients will receive open-label MK-0518 400 mg twice daily, in addition to optimized background therapy (OBT). Investigators will select the OBT based on the patient's prior treatment history and anti-retroviral resistance testing. OBT will not be provided by Merck. Safety and tolerability of MK-0518 will be monitored.
The program will be managed by a clinical research organization (CRO). The CRO will collect all case report information including serious adverse events and drug-related adverse events that result in Grade 3 or above laboratory toxicity, leading to treatment interruption or discontinuation. No efficacy data will be collected.
About Merck's HIV/AIDS research program
Merck's HIV clinical research program began in 1985. Merck scientists were among the first to discover and develop medicines for the treatment of HIV/AIDS. In 1996, Merck introduced a protease inhibitor, which was followed by the introduction in 1999 of a non-nucleoside reverse transcriptase inhibitor (NNRTI).
In addition to MK-0518, Merck is focused on developing new treatments for millions of individuals who are already infected with HIV, as well as on preventing HIV transmission through the development of a vaccine. Merck also licensed a compound to the International Partnership for Microbicides (IPM) for development as a possible means of preventing HIV infection in women.
Sunday, August 13, 2006
Polycythemia, Anabolic Steroids and HIV Wasting
Some HIV positive people need to gain lean body mass and weight but develop polycythemia when using nandrolone or other anabolics, so their doctors refuse to prescribe these important medicines. Polycythemia is an increase in red blood cells and hematocrit that can cause increased blood viscosity, making it more difficult for the heart to pump blood. This can cause heart attackes or strokes, so it is important to know how to manage this problem. Lyckily, only a very small number of people using anabolics have this problem. We still do not know what makes one person more suceptible than other.
I had this problem for 5 months back when I was on Crixivan. For reasons that I do not understand yet, it went away once I stopped Crixivan. I also think using AZT may have a controlling effect on red blood cells.
This first article explains why anabolics increase red blood cells
Anabolic Steroids and Red Blood Cellshttp://www.mesomorphosis.com/articles/llewellyn/steroids-and-red-blood-cells.htm
Dr Scally has been able to write a very good article to teach doctors how to manage the problem
How to Manage Polycythemia Induced by Anabolic Steroids
By Michael C. Scally M.D.
For better formatting , see
http://health.groups.yahoo.com/group/PozHealth/message/16494
Dr. Michael C. Scally a Harvard and MIT trained physician and researcher in private practice in Houston who has written extensively on hormonal issues and HIV.
During the past few years, his focus have been on managing induced hypogonadism (low testosterone production by the body) after anabolic steroid therapy by restoring HPGA (Hypothalamic Pituitary Gonadal Axis) and managing polycythemia (increased red blood count that increases blood viscosity and cardiovascular disease risks.) This takes on particular importance as hormonal therapies become standard of care in HIV. His development of a new therapeutic approach is detailed in this report, and we are very excited to make it available to our readers.
Anabolic Steroid Use in HIV: Managing Androgen Induced Polycythemia and Hypogonadism
Wasting is one of the most common symptoms of human immunodeficiency virus (HIV). Wasting syndrome is widely considered the involuntary loss of 10% of initial body weight, many times in combination with diarrhea, weakness, and fever (Revision of the CDC surveillance case definition for acquired immunodeficiency syndrome. MMWR Morb. Mortal Wkly. Rep. 1987; 36 Supp.l 1). This condition may be attributed from malnutrition, diarrhea, altered metabolism, malabsorption, or hypogonadism associated with HIV infection. Since there is an increased mortality rate of HIV patients suffering with substantial body weight loss, aggressive therapies aimed at retaining lean body mass have been pursued.
One particular modality that has shown to be effective in preserving lean body weight is anabolic androgenic steroid (AAS) or androgen therapy. Multiple studies have evaluated the effects of androgens on combating wasting in HIV+ males. These reports have shown significant improvements in lean body mass up to 5.6 kg over short-term usage. While other HIV associated wasting and retroviral therapies may improve total body weight, androgen therapy has demonstrated an increase in fat free weight without a concurrent increase in fat mass. Unfortunately, therapies utilizing protease inhibitors or dietary counseling for wasting syndrome have found larger increases in fat tissue than improvements in muscle mass, thus granting minimal improvements in immune function and metabolism.
Along with the documentation and dissemination of the benefits of androgen therapy in treating wasting syndrome has come an associated acceptability within the medical community in prescribing these medicines. Research articles discussing the use of androgens in HIV+ patients are becoming more prevalent in the medical literature. A drawback of the increased utilization of androgens, however, are those scenarios where patients are administered these medicines for lengthy durations. Extended, uninterrupted use of androgens has been shown to induce polycythemia. Defined as a chronic myeloproliferative disorder characterized by an increase in hemoglobin concentration and red blood cell (RBC) mass (erythrocytosis), polycythemia increases the risk of thrombosis, post polycythemia myeloid metaplasia, and acute leukemia. Androgens, by increasing the endogenous production of erythropoietin, enhance the body̢۪s rate of erythropoiesis and subsequently hemoglobin and RBC mass. With increased viscosity of the blood and platelets, an increased risk of blood clotting, heart attack, and stroke becomes a primary concern with patients afflicted with polycythemia. In terms of androgens, uninterrupted treatment may potentially do greater harm than good when faced with the possibility of problematic polycythemia secondary to androgen therapy.
The following is a report of problematic polycythemia as a result of long-term androgen therapy in an HIV+ male.
Case
A 46-year old HIV+ male presented with complaints of shortness-of breath, fatigue, excessive sweating and facial erythema. Medical history revealed a record of uninterrupted testosterone administration for the two years prior to presentation. The patient was administered testosterone cypionate, 200 mg IM per week, for two years to help sustain lean muscle mass in the prevention of HIV associated wasting syndrome. Laboratory studies revealed polycythemia but were otherwise unremarkable. An attempt at discontinuation of androgen therapy precipitated problematic hypogonadism exhibited by lethargy, diminished libido, decreased energy, sleep disturbance and depression. Testosterone treatment was restarted and the patient referred for consultation.
On presentation vital signs and weight, 75kg, were within normal limits. Original baseline laboratory studies prior to testosterone administration revealed normal CBC and hormone profile, Table 1.
Table 1.
Test
Hgb (gm/dL)
Hct (%)
RBC (M/uL)
LH(mIU/mL)
T (ng/dL)
Value
15.8
48.2
5.48
3.4
470
Reference
Range
13.2-17.1
38.5-50.0
4.2-5.8
1.5-9.3
241-827
Hgb “ Hemoglobin
Hct “ Hematocrit
LH “ Luteinizing Hormone
T- Total Testosterone
Laboratory values on the consultation presentation are shown in Table 2.
Table 2.
Test
Hgb (gm/dL)
Hct (%)
RBC (M/uL)
LH (mIU/mL)
T (ng/dL)
Value
18.0
60.0
6.09
<0.2
1200
Therapy was directed two-fold towards the androgen-induced polycythemia. First, the elevated Hemoglobin/Hematocrit was addressed by a therapeutic phlebotomy. Secondly, the increased rate of erythropoiesis was normalized by removing the androgen stimulus. In order to avoid the previous problematic hypogonadism upon androgen cessation a medical protocol for hypothalamic-pituitary-testicular axis (HPTA) normalization was administered.
Therapeutic phlebotomy was initiated to restore normal red blood cell indices. The approximate amount of blood volume that needed to be withdrawn to restore normal values can be calculated by the following formula. This use of the formula includes the assumption that whole blood is withdrawn. Also the duration of time over which the blood volume is withdrawn is affected by whether or not concurrent fluid replacement occurs.
CC of Blood Volume Drawn = Wt(kg) x ABV x [Hgbi - Hgbf] / [(Hgbi + Hgbf)/2]
ABV= Average Blood Volume (default = 70)
Hgbi (Hcti) = Hemoglobin initial
Hgbf (Hctf) = Hemoglobin final (desired); or
CC = 75 X 70 X [20-14]/[(20+14)/2] = 75 X 70 X (6/17) = ~1850;
@ 1Unit Whole Blood = ~350 - 450 CC; ~1850/(350 – 450) = ~4 Units
For a final hemoglobin of 14 a therapeutic phlebotomy of ~4 Units whole blood will be
required.
To return the rate of erythropoiesis to normal it is necessary to remove the androgen stimulus to erythropoietin production. In order to avoid the problematic hypogonadism mentioned previously after androgen cessation a medical protocol was administered for HPTA normalization. The protocol consisted of the medications human chorionic gonadotropin (hCG), Clomiphene citrate and Tamoxifen. Treatment takes place over two discrete intervals. The first treatment interval is to initiate the restoration of testicular function while the latter is for the coupling and restoration of the hypothalamus/pituitary and testicles.
The medications were initiated simultaneously at a time when it was expected that the body would be expected to begin endogenous testosterone production. Since the source of the exogenous androgen was depotestosterone (testosterone cypionate) with a known half-life the date to begin the medical protocol can be predicted with some accuracy. hCG 2500 U SC QOD (every other day); Clomiphene Citrate 50MG I PO BID (oral , twice a day); and Tamoxifen 20MG I PO QD (oral, once a day) were administered for 15 days. A satisfactory testosterone level on day 15, typically 350 or greater, is followed by the oral medications for an additional 15 days. This patient had a testosterone level of 423 after the initial treatment interval. Upon completion of the medications and a therapeutic phlebotomy as noted above during this period followed by a two week washout period the patient had the following laboratory values, Table 3.
Table 3.
Test
Hgb (gm/dL)
Hct (%)
RBC (M/uL)
LH (mIU/mL)
T (ng/dL)
Value
14.1
43.5
4.68
7.3
626
Discussion
This case report is not intended to oppose the use of testosterone or any androgen in the treatment/prevention of HIV associated wasting syndrome. On the contrary, these medicines have proven their worth in retaining lean body mass in HIV+ patients. Nevertheless, attention needs to be drawn to the possible complications of long-term, uninterrupted androgen usage. Toxic effects on liver function have been shown to occur from long-term oral androgen usage. While this effect of androgens is usually associated with only orally active 17-alkylated compounds, all medicines in this class have the potential to cause liver abnormalities, especially at higher dosages and long-term, uninterrupted administration. Previous research dictates that negative lipid alterations can occur almost immediately after testosterone administration. Although the suppression of HDL cholesterol by androgens is quickly reversible upon discontinuation, there is speculation as to the increased risk of cardiovascular disease while supplementing with androgens. As described in this case report, extended, uninterrupted usage of androgens can cause secondary polycythemia. Periodic discontinuation of these medicines can be beneficial to the health of the patient in terms of preventing hepatotoxicity, negative alterations in lipid profile, and polycythemia.
Patients administered androgens for muscle wasting conditions, osteoporosis, anemia, or any other disorder not associated with primary hypogonadism should be discontinued from treatment on a periodic basis to ensure safe return of testicular function and prevent side effects linked to long term, continuous usage. Conversely, in cases of primary testicular failure that does not respond to stimulation therapy, indefinite testosterone replacement without cessation may be required.
Therapies utilizing human chorionic gonadotropin and clomiphene citrate have been proposed as treatment modalities for return of testicular and pituitary function, respectively. While this treatment needs to be evaluated in more extensive controlled studies, the medical literature gives credence to the possible benefits of its use . In the case of preventing androgen induced hypogonadism, this treatment option may prove to be very valuable.
If rapid return of testicular and pituitary function post androgen treatment can be achieved, the attendant effects of androgen-induced hypogonadism (AIH); muscle atrophy, increased adiposity, depressed libido, erection dysfunction, lethargy, and depression, that are typically associated with androgen cessation may be avoided. In cases of sustained hypogonadism that can result for almost two years post therapy , progressive decrease in muscle mass, osteoporosis, oligospermia or azoospermia, and severe mood disturbances may result . Periodic discontinuation of androgen treatment would avoid possible complications due to polycythemia, liver hepatotoxicity, and suppressed HDL-C while simultaneously retaining all of the positive benefits gained during androgen therapy. It̢۪s alarming to realize that the beneficial aspects of androgen supplementation can become transient in the face of post-therapy hypogonadism, thus making androgen therapy an insignificant treatment option if ensuing hypogonadism is disregarded. On the other hand, if androgens can be administered in short term durations to avoid associated side effects while retaining lean body mass gains post-therapy, safe and efficacious use can be applied to numerous patient populations.
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21. Tash, J.A., J.H. McGovern, and P.N. Schlegel, Acquired hypogonadotropic hypogonadism presenting as decreased seminal volume. Urology, 2000. 56(4): p. 669.
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24. Menon, D.K., Successful treatment of anabolic steroid-induced azoospermia with human chorionic gonadotropin and human menopausal gonadotropin. Fertil Steril, 2003. 79 Suppl 3: p. 1659-61.
25. Gazvani, M.R., et al., Conservative management of azoospermia following steroid abuse. Hum Reprod, 1997. 12(8): p. 1706-8.
26. Jarow, J.P. and L.I. Lipshultz, Anabolic steroid-induced hypogonadotropic hypogonadism. Am J Sports Med, 1990. 18(4): p. 429-31.
27. Petak, S.M., et al., AACE Clinical Practice Guidelines for the Evaluation and Treatment of Hypogonadism in Adult Male Patients. Endocrine Practice, 1996. 2(6): p. 440-453.
I had this problem for 5 months back when I was on Crixivan. For reasons that I do not understand yet, it went away once I stopped Crixivan. I also think using AZT may have a controlling effect on red blood cells.
This first article explains why anabolics increase red blood cells
Anabolic Steroids and Red Blood Cellshttp://www.mesomorphosis.com/articles/llewellyn/steroids-and-red-blood-cells.htm
Dr Scally has been able to write a very good article to teach doctors how to manage the problem
How to Manage Polycythemia Induced by Anabolic Steroids
By Michael C. Scally M.D.
For better formatting , see
http://health.groups.yahoo.com/group/PozHealth/message/16494
Dr. Michael C. Scally a Harvard and MIT trained physician and researcher in private practice in Houston who has written extensively on hormonal issues and HIV.
During the past few years, his focus have been on managing induced hypogonadism (low testosterone production by the body) after anabolic steroid therapy by restoring HPGA (Hypothalamic Pituitary Gonadal Axis) and managing polycythemia (increased red blood count that increases blood viscosity and cardiovascular disease risks.) This takes on particular importance as hormonal therapies become standard of care in HIV. His development of a new therapeutic approach is detailed in this report, and we are very excited to make it available to our readers.
Anabolic Steroid Use in HIV: Managing Androgen Induced Polycythemia and Hypogonadism
Wasting is one of the most common symptoms of human immunodeficiency virus (HIV). Wasting syndrome is widely considered the involuntary loss of 10% of initial body weight, many times in combination with diarrhea, weakness, and fever (Revision of the CDC surveillance case definition for acquired immunodeficiency syndrome. MMWR Morb. Mortal Wkly. Rep. 1987; 36 Supp.l 1). This condition may be attributed from malnutrition, diarrhea, altered metabolism, malabsorption, or hypogonadism associated with HIV infection. Since there is an increased mortality rate of HIV patients suffering with substantial body weight loss, aggressive therapies aimed at retaining lean body mass have been pursued.
One particular modality that has shown to be effective in preserving lean body weight is anabolic androgenic steroid (AAS) or androgen therapy. Multiple studies have evaluated the effects of androgens on combating wasting in HIV+ males. These reports have shown significant improvements in lean body mass up to 5.6 kg over short-term usage. While other HIV associated wasting and retroviral therapies may improve total body weight, androgen therapy has demonstrated an increase in fat free weight without a concurrent increase in fat mass. Unfortunately, therapies utilizing protease inhibitors or dietary counseling for wasting syndrome have found larger increases in fat tissue than improvements in muscle mass, thus granting minimal improvements in immune function and metabolism.
Along with the documentation and dissemination of the benefits of androgen therapy in treating wasting syndrome has come an associated acceptability within the medical community in prescribing these medicines. Research articles discussing the use of androgens in HIV+ patients are becoming more prevalent in the medical literature. A drawback of the increased utilization of androgens, however, are those scenarios where patients are administered these medicines for lengthy durations. Extended, uninterrupted use of androgens has been shown to induce polycythemia. Defined as a chronic myeloproliferative disorder characterized by an increase in hemoglobin concentration and red blood cell (RBC) mass (erythrocytosis), polycythemia increases the risk of thrombosis, post polycythemia myeloid metaplasia, and acute leukemia. Androgens, by increasing the endogenous production of erythropoietin, enhance the body̢۪s rate of erythropoiesis and subsequently hemoglobin and RBC mass. With increased viscosity of the blood and platelets, an increased risk of blood clotting, heart attack, and stroke becomes a primary concern with patients afflicted with polycythemia. In terms of androgens, uninterrupted treatment may potentially do greater harm than good when faced with the possibility of problematic polycythemia secondary to androgen therapy.
The following is a report of problematic polycythemia as a result of long-term androgen therapy in an HIV+ male.
Case
A 46-year old HIV+ male presented with complaints of shortness-of breath, fatigue, excessive sweating and facial erythema. Medical history revealed a record of uninterrupted testosterone administration for the two years prior to presentation. The patient was administered testosterone cypionate, 200 mg IM per week, for two years to help sustain lean muscle mass in the prevention of HIV associated wasting syndrome. Laboratory studies revealed polycythemia but were otherwise unremarkable. An attempt at discontinuation of androgen therapy precipitated problematic hypogonadism exhibited by lethargy, diminished libido, decreased energy, sleep disturbance and depression. Testosterone treatment was restarted and the patient referred for consultation.
On presentation vital signs and weight, 75kg, were within normal limits. Original baseline laboratory studies prior to testosterone administration revealed normal CBC and hormone profile, Table 1.
Table 1.
Test
Hgb (gm/dL)
Hct (%)
RBC (M/uL)
LH(mIU/mL)
T (ng/dL)
Value
15.8
48.2
5.48
3.4
470
Reference
Range
13.2-17.1
38.5-50.0
4.2-5.8
1.5-9.3
241-827
Hgb “ Hemoglobin
Hct “ Hematocrit
LH “ Luteinizing Hormone
T- Total Testosterone
Laboratory values on the consultation presentation are shown in Table 2.
Table 2.
Test
Hgb (gm/dL)
Hct (%)
RBC (M/uL)
LH (mIU/mL)
T (ng/dL)
Value
18.0
60.0
6.09
<0.2
1200
Therapy was directed two-fold towards the androgen-induced polycythemia. First, the elevated Hemoglobin/Hematocrit was addressed by a therapeutic phlebotomy. Secondly, the increased rate of erythropoiesis was normalized by removing the androgen stimulus. In order to avoid the previous problematic hypogonadism upon androgen cessation a medical protocol for hypothalamic-pituitary-testicular axis (HPTA) normalization was administered.
Therapeutic phlebotomy was initiated to restore normal red blood cell indices. The approximate amount of blood volume that needed to be withdrawn to restore normal values can be calculated by the following formula. This use of the formula includes the assumption that whole blood is withdrawn. Also the duration of time over which the blood volume is withdrawn is affected by whether or not concurrent fluid replacement occurs.
CC of Blood Volume Drawn = Wt(kg) x ABV x [Hgbi - Hgbf] / [(Hgbi + Hgbf)/2]
ABV= Average Blood Volume (default = 70)
Hgbi (Hcti) = Hemoglobin initial
Hgbf (Hctf) = Hemoglobin final (desired); or
CC = 75 X 70 X [20-14]/[(20+14)/2] = 75 X 70 X (6/17) = ~1850;
@ 1Unit Whole Blood = ~350 - 450 CC; ~1850/(350 – 450) = ~4 Units
For a final hemoglobin of 14 a therapeutic phlebotomy of ~4 Units whole blood will be
required.
To return the rate of erythropoiesis to normal it is necessary to remove the androgen stimulus to erythropoietin production. In order to avoid the problematic hypogonadism mentioned previously after androgen cessation a medical protocol was administered for HPTA normalization. The protocol consisted of the medications human chorionic gonadotropin (hCG), Clomiphene citrate and Tamoxifen. Treatment takes place over two discrete intervals. The first treatment interval is to initiate the restoration of testicular function while the latter is for the coupling and restoration of the hypothalamus/pituitary and testicles.
The medications were initiated simultaneously at a time when it was expected that the body would be expected to begin endogenous testosterone production. Since the source of the exogenous androgen was depotestosterone (testosterone cypionate) with a known half-life the date to begin the medical protocol can be predicted with some accuracy. hCG 2500 U SC QOD (every other day); Clomiphene Citrate 50MG I PO BID (oral , twice a day); and Tamoxifen 20MG I PO QD (oral, once a day) were administered for 15 days. A satisfactory testosterone level on day 15, typically 350 or greater, is followed by the oral medications for an additional 15 days. This patient had a testosterone level of 423 after the initial treatment interval. Upon completion of the medications and a therapeutic phlebotomy as noted above during this period followed by a two week washout period the patient had the following laboratory values, Table 3.
Table 3.
Test
Hgb (gm/dL)
Hct (%)
RBC (M/uL)
LH (mIU/mL)
T (ng/dL)
Value
14.1
43.5
4.68
7.3
626
Discussion
This case report is not intended to oppose the use of testosterone or any androgen in the treatment/prevention of HIV associated wasting syndrome. On the contrary, these medicines have proven their worth in retaining lean body mass in HIV+ patients. Nevertheless, attention needs to be drawn to the possible complications of long-term, uninterrupted androgen usage. Toxic effects on liver function have been shown to occur from long-term oral androgen usage. While this effect of androgens is usually associated with only orally active 17-alkylated compounds, all medicines in this class have the potential to cause liver abnormalities, especially at higher dosages and long-term, uninterrupted administration. Previous research dictates that negative lipid alterations can occur almost immediately after testosterone administration. Although the suppression of HDL cholesterol by androgens is quickly reversible upon discontinuation, there is speculation as to the increased risk of cardiovascular disease while supplementing with androgens. As described in this case report, extended, uninterrupted usage of androgens can cause secondary polycythemia. Periodic discontinuation of these medicines can be beneficial to the health of the patient in terms of preventing hepatotoxicity, negative alterations in lipid profile, and polycythemia.
Patients administered androgens for muscle wasting conditions, osteoporosis, anemia, or any other disorder not associated with primary hypogonadism should be discontinued from treatment on a periodic basis to ensure safe return of testicular function and prevent side effects linked to long term, continuous usage. Conversely, in cases of primary testicular failure that does not respond to stimulation therapy, indefinite testosterone replacement without cessation may be required.
Therapies utilizing human chorionic gonadotropin and clomiphene citrate have been proposed as treatment modalities for return of testicular and pituitary function, respectively. While this treatment needs to be evaluated in more extensive controlled studies, the medical literature gives credence to the possible benefits of its use . In the case of preventing androgen induced hypogonadism, this treatment option may prove to be very valuable.
If rapid return of testicular and pituitary function post androgen treatment can be achieved, the attendant effects of androgen-induced hypogonadism (AIH); muscle atrophy, increased adiposity, depressed libido, erection dysfunction, lethargy, and depression, that are typically associated with androgen cessation may be avoided. In cases of sustained hypogonadism that can result for almost two years post therapy , progressive decrease in muscle mass, osteoporosis, oligospermia or azoospermia, and severe mood disturbances may result . Periodic discontinuation of androgen treatment would avoid possible complications due to polycythemia, liver hepatotoxicity, and suppressed HDL-C while simultaneously retaining all of the positive benefits gained during androgen therapy. It̢۪s alarming to realize that the beneficial aspects of androgen supplementation can become transient in the face of post-therapy hypogonadism, thus making androgen therapy an insignificant treatment option if ensuing hypogonadism is disregarded. On the other hand, if androgens can be administered in short term durations to avoid associated side effects while retaining lean body mass gains post-therapy, safe and efficacious use can be applied to numerous patient populations.
References
1. Palenicek, J.P., et al., Weight loss prior to clinical AIDS as a predictor of survival. Multicenter AIDS Cohort Study Investigators. J Acquir Immune Defic Syndr Hum Retrovirol, 1995. 10(3): p. 366-73.
2. Guenter, P., et al., Relationships among nutritional status, disease progression, and survival in HIV infection. J Acquir Immune Defic Syndr, 1993. 6(10): p. 1130-8.
3. Batterham, M.J. and R. Garsia, A comparison of megestrol acetate, nandrolone decanoate and dietary counselling for HIV associated weight loss. Int J Androl, 2001. 24(4): p. 232-40.
4. Fairfield, W.P., et al., Effects of testosterone and exercise on muscle leanness in eugonadal men with AIDS wasting. J Appl Physiol, 2001. 90(6): p. 2166-71.
5. Fox-Wheeler, S., et al., Evaluation of the effects of oxandrolone on malnourished HIV-positive pediatric patients. Pediatrics, 1999. 104(6): p. e73.
6. Gold, J., et al., Safety and efficacy of nandrolone decanoate for treatment of wasting in patients with HIV infection. Aids, 1996. 10(7): p. 745-52.
7. Grinspoon, S., et al., Effects of testosterone and progressive resistance training in eugonadal men with AIDS wasting. A randomized, controlled trial. Ann Intern Med, 2000. 133(5): p. 348-55.
8. Sattler, F.R., et al., Effects of pharmacological doses of nandrolone decanoate and progressive resistance training in immunodeficient patients infected with human immunodeficiency virus. J Clin Endocrinol Metab, 1999. 84(4): p. 1268-76.
9. Strawford, A., et al., Resistance exercise and supraphysiologic androgen therapy in eugonadal men with HIV-related weight loss: a randomized controlled trial. Jama, 1999. 281(14): p. 1282-90.
10. Strawford, A., et al., Effects of nandrolone decanoate therapy in borderline hypogonadal men with HIV-associated weight loss. J Acquir Immune Defic Syndr Hum Retrovirol, 1999. 20(2): p. 137-46.
11. Carbonnel, F., et al., Effect of indinavir on HIV-related wasting. Aids, 1998. 12(14): p. 1777-84.
12. Silva, M., et al., The effect of protease inhibitors on weight and body composition in HIV-infected patients. Aids, 1998. 12(13): p. 1645-51.
13. Gorshein, D., S. Murphy, and F.H. Gardner, Comparative study on the erythropoietic effects of androgens and their mode of action. J Appl Physiol, 1973. 35(3): p. 276-8.
14. Hajjar, R.R., F.E. Kaiser, and J.E. Morley, Outcomes of long-term testosterone replacement in older hypogonadal males: a retrospective analysis. J Clin Endocrinol Metab, 1997. 82(11): p. 3793-6.
15. Viallard, J.F., et al., Polycythaemia as a complication of transdermal testosterone therapy. Br J Haematol, 2000. 110(1): p. 237-8.
16. Evens, R.P. and A.B. Amerson, Androgens and erythropoiesis. J Clin Pharmacol, 1974. 14(2): p. 94-101.
17. Soe, K.L., M. Soe, and C. Gluud, Liver pathology associated with the use of anabolic-androgenic steroids. Liver, 1992. 12(2): p. 73-9.
18. Bagatell, C.J., et al., Physiologic testosterone levels in normal men suppress high-density lipoprotein cholesterol levels. Ann Intern Med, 1992. 116(12 Pt 1): p. 967-73.
19. Friedl, K.E., et al., High-density lipoprotein cholesterol is not decreased if an aromatizable androgen is administered. Metabolism, 1990. 39(1): p. 69-74.
20. Burge, M.R., et al., Idiopathic hypogonadotropic hypogonadism in a male runner is reversed by clomiphene citrate. Fertil Steril, 1997. 67(4): p. 783-5.
21. Tash, J.A., J.H. McGovern, and P.N. Schlegel, Acquired hypogonadotropic hypogonadism presenting as decreased seminal volume. Urology, 2000. 56(4): p. 669.
22. Ross, L.S., et al., Clomiphene treatment of the idiopathic hypofertile male: high-dose, alternate-day therapy. Fertil Steril, 1980. 33(6): p. 618-23.
23. Tan, R.S. and D. Vasudevan, Use of clomiphene citrate to reverse premature andropause secondary to steroid abuse. Fertil Steril, 2003. 79(1): p. 203-5.
24. Menon, D.K., Successful treatment of anabolic steroid-induced azoospermia with human chorionic gonadotropin and human menopausal gonadotropin. Fertil Steril, 2003. 79 Suppl 3: p. 1659-61.
25. Gazvani, M.R., et al., Conservative management of azoospermia following steroid abuse. Hum Reprod, 1997. 12(8): p. 1706-8.
26. Jarow, J.P. and L.I. Lipshultz, Anabolic steroid-induced hypogonadotropic hypogonadism. Am J Sports Med, 1990. 18(4): p. 429-31.
27. Petak, S.M., et al., AACE Clinical Practice Guidelines for the Evaluation and Treatment of Hypogonadism in Adult Male Patients. Endocrine Practice, 1996. 2(6): p. 440-453.
Thursday, July 20, 2006
Transcript of The Body's Live Chat on Multidrug Resistance
The Body
Transcript of The Body's Live Chat on Multidrug Resistance With Nelson Vergel
July 10, 2006
Following is the transcript of The Body's live chat on multidrug resistance, which took place on July 10, 2006, at 3:30 p.m. Eastern Time. The chat was moderated by The Body's editorial staff and hosted by HIV treatment advocate Nelson Vergel. This transcript has been edited for grammar and clarity. Additional follow-up information was obtained from the host after the chat's conclusion.
This is the seventh chat that The Body has moderated; to see transcripts of previous chats, click here.
Moderator: Thank you for coming to The Body's live, interactive chat on HIV treatment issues for people with multidrug resistance. We're about to get things started! A quick note before we get going: Please keep in mind that the information we provide in this chat is not meant to replace the attention or advice of a doctor or another health care professional. Make sure you consult with a qualified health care professional before making any dietary, drug, exercise or other lifestyle change!
Nelson, before we begin answering everyone's questions, why don't you take a few minutes to tell folks a bit about yourself?
Nelson Vergel: My name is Nelson Vergel. I have been positive for 23 years. Until recently, I have never had an undetectable viral load. I have been a victim of sequential (or virtual) monotherapy (adding a new agent to a failing regimen). I started AZT [brand name: Retrovir; also known generically as zidovudine] as monotherapy in the late 1980s. Treatment with individual nucleosides followed, and I subsequently developed resistance to each of them. [I was started on] saquinavir [brand names: Fortovase, Invirase] treatment in 1996, but due to its low absorption in my body, I developed resistance to it and to most protease inhibitors.
I tried Viramune [generic name: nevirapine] and Sustiva [generic name: efavirenz; also known by the brand name Stocrin] and also developed resistance to them pretty quickly. Next, I tried Kaletra [generic name: lopinavir/ritonavir] in combination with Invirase; this stabilized my CD4 cells in the 500 range for a few years. After 2002, my CD4 cells declined gradually while my viral load stayed in the 20,000-60,000 range, even with mega-HAART regimens (more than four drugs). I then started Fuzeon [generic name: enfuvirtide; also known as T-20] on top of my failing regimen, and it stabilized me for two years more.
Two months ago, my CD4 cells had dropped to 180 and my viral load was around 40,000. I joined the Merck integrase study and started Prezista [generic name: darunavir; also known as TMC114] at kept Viread [generic name: tenofovir] and Combivir [generic name: zidovudine/lamivudine; also known as AZT/3TC] in my background therapy. My viral load now is undetectable for the first time and my CD4s have gone up to 260. I am excited and hopeful.
I have been an HIV treatment activist since 1988. I have also been lucky to be part of the AIDS Treatment Activists Coalition. This has given me the opportunity to interact with pharmaceutical companies, researchers, the FDA [U.S. Food and Drug Administration], and key activists to learn a lot about drug development and give input into research studies. I am the founder of salvagetherapies.org, facialwasting.org, medibolics.com, and the largest HIV discussion group on the Internet (PozHealth at Yahoo.com). I am also the co-author of the book "Built to Survive." My main goal, currently, is to educate HIV-positive people living with multidrug resistance about current and future options, so that they avoid adding a single new active drug to a failing regimen, as this does not maximize their long-term chances for viral control and survival. For more information about my non-profit organization, PoWeR- Program for Wellness Restoration, go to powerusa.org.
Moderator: Thanks, Nelson -- and congrats on your successful new med regimen! Let's start the chat! Please feel free to submit any questions you have for today's speaker: Nelson Vergel, a leading patient advocate in the field of multidrug resistance.
Question from anonymous: Nelson thanks a lot for sharing your knowledge with us. I have nothing left that works for me. I took Fuzeon for eight months, but it stopped working. My T cells are 60 and my viral load is 80,000. My doctor wants me to start the new drug Prezista and start Fuzeon again. I am not sure what to do. What would you do, if you were me?
Answer from Nelson Vergel: I am sorry that you are going through the stress of trying to find new options to control your HIV. Luckily, we are about to have a few more options than [we have had] in the past few years. I would suggest that you talk to your doctor about running a genotype test for Fuzeon to see if there is still any activity to it for you. But chances are that you may already have resistance to it. Some clinicians also may argue that even if sensitivity to Fuzeon shows in your genotype test, it may actually be a case of "archived resistance" that may reemerge pretty quickly after you restart Fuzeon.
Luckily, we may have three new medications (Merck's integrase inhibitor [MK-0518], Tibotec's TMC 125 (etravirine- a non-nucleoside), and Pfizer's maraviroc [also known as UK-427,857], a CCR5 entry inhibitor) in expanded access in the next few months that we can use to avoid "virtual monotherapy" and to give us the luxury of starting two to three new agents at the same time. There are also two other products coming up in phase III studies soon: Gilead's integrase inhibitor [GS 9137] and Tanox's TNX-355 (an IV [intravenous] that will be administered every two weeks). These two phase III studies also will provide options with which to combine Prezista and/or Fuzeon. I hope that Merck, Tibotec and Pfizer will work together to allow the use of their drugs in each other's expanded access. This will be the first time in HIV history that we will have the luxury of three agents being available close to each other.
Your doctor will be able to help you determine if you should stay on a "holding pattern regimen" until you can start at least two new agents. It is a very difficult decision that needs to weigh your current symptoms and past CD4-decline trend.
Moderator: You can learn a bit more about Merck's integrase inhibitor MK-0518 by visiting: www.thebody.com/treat/mk0518.html.
Question from swhoutx025: Will I develop drug resistance even if I am vigilant and adherent to my current HAART therapy (Sustiva + Truvada [generic name: tenofovir/emtricitabine; also known as TDF/FTC])?
Answer from Nelson Vergel: In my 10 years of lecturing around the country, I have met many people who have been on their first regimen for many years. There is no reason why you should not be successful at keeping your viral load undetectable for a long time, if you are adherent to your meds.
Question from anonymous: Nelson, I hear that there is an oral Fuzeon coming out. Is that true and when? What new drugs are coming out in the next year? I have run out of everything and my T cells are low, but my doctor tells me to be patient.
Answer from Nelson Vergel: No, not really. Roche is investigating injectable fusion inhibitors that may be administered once a week, but this work is in very preliminary stages. Some people may confuse the oral CCR5 entry inhibitor class with fusion inhibitors, however. The medical and treatment advocacy community is anxiously waiting to see data from Pfizer's maraviroc study in treatment-experienced patients in the next few months. Maraviroc is an oral entry inhibitor that may work as an "add-on" to HAART in patients with multidrug resistance.
Question from anonymous: Nelson, I have resistance to all medications, including Fuzeon. My T cells are only 5 and my viral load is 80,000. I am very afraid of having a flare-up of my old CMV [cytomegalovirus]. I have a good doctor [who is up-to-date] with all the studies for salvage. He has offered to enter me in the DUET study of TMC125 [generic name: etravirine] or the Merck integrase study. I do not know what to do. I want to survive and get better. Do you know anything about these studies? Should I join or do something else?
Answer from Nelson Vergel: I am sorry that you are going through such a stressful dilemma. But, in a way, think about how many options you have now that you did not have just a few months ago! Tibotec's DUET studies (DUET 1 and 2) are being conducted in the hopes to get a new non-nuke, TMC125, approved. Fifty percent of patients will be randomized to ritonavir [brand name: Norvir]-boosted TMC114 + TMC125 + nukes with or without Fuzeon; the other 50 percent of patients will be enrolled in ritonavir-boosted TMC114 + placebo TMC125 + nukes with or without Fuzeon.
Since you have resistance to both nukes and Fuzeon, you may be exposed to only one "active" agent (TMC114) in the placebo arm. Tibotec will rollover anyone who does not have virologic control in the placebo arm at month six to open-label TMC125. From data in POWER 1 and 2 (the studies that got Prezista approved), we know that around 18 percent of patients with no active agents left achieved an undetectable viral load at week 24 with Prezista (this may or may not be similar to the response we may see in the DUET placebo arm).
As of mid July 2006, the DUET studies are almost fully enrolled. Tibotec will be providing TMC 125 in expanded access in a few months.
For those with very low CD4 cells, declining health, and no active agents left, Tibotec may provide TMC125 in an emergency IND (Investigational New Drug) program [which doctors can use to get access to an investigational drug] depending on the patient's clinical picture. This way, you may be able to construct a two-active drug regimen with Prezista + TMC125. However, your doctor has to justify to the company that you are not a good candidate for DUET due to your health and the risk of virtual monotherapy in the placebo arm. It is not a simple process since they have to agree to give you the drug, get your doctor to fill out two forms for the FDA, and get your doctor to get local IRB (institutional review board) approval for your application. More details on this is available at salvagetherapies.org.
In the Merck integrase study (BENCHMRK study to get MK-0518 approved), you have a 33 percent chance of being randomized to placebo MK-0518. Merck will rollover those in the placebo arm to treatment at week 16 if no virologic control is attained. You can use Prezista, nukes, non-nukes, and Fuzeon in this study. This study may be closed to enrollment soon since it has accrued really fast. We are hopeful that Merck will provide this drug in expanded access before the end of this year, which may give people an opportunity to construct a regimen with more than one active agent. Regimens like Prezista + MK-0518 + TMC 125 + nukes with or without Fuzeon will be a reality in the near future.
Moderator: The DUET studies that Nelson referred to are currently enrolling multidrug-resistant HIVers in the United States and several other countries. To learn more about these trials, visit: www.clinicaltrials.gov/ct/show/NCT00255099 and www.clinicaltrials.gov/ct/show/NCT00254046 (each trial has different testing sites, so check each one to see if it has a site near where you live or work).
Question from anonymous: Do you know much about the new "black box" warning that Aptivus [generic name: tipranavir] can cause "intracranial hemorrhage" or something like that? What does it mean, and should I be worried about it?
Answer from Nelson Vergel: The maker of Aptivus has reported 14 cases of intracranial hemorrhage events, including eight fatalities, in 6,840 HIV-1-infected individuals receiving Aptivus capsules in combination antiretroviral therapy in clinical trials (0.2 % of all patients in the study.) Many of the patients who experienced this problem had other medical conditions -- CNS [central nervous system] lesions, head trauma, recent neurosurgery, coagulopathy (when bleeding following an injury is prolonged and excessive), hypertension or alcohol abuse -- or were receiving concomitant medications, including anticoagulants and antiplatelet agents, that may have caused or contributed to these events. It also seems that this problem had been observed before in people with advanced disease taking other protease inhibitors in the past.
Boehringer Ingelheim is investigating this problem right now in more detail. Physicians have been informed to closely monitor patients who may have any of the risks factors mentioned. Aptivus is a protease inhibitor that has helped many patients with multiple protease resistance. Those who are benefiting from it should discuss this new information with their physicians, especially if they have any of the risks factors mentioned above. We will know more details about this in a few weeks, hopefully.
Moderator: You can read more about the tipranavir "black box" warning at: www.thebody.com/kaiser/2006/jul3_06/aptivus_warning.html.
Question from Dora: I was wondering if you read Rob Camp's analysis of TMC114 for Treatment Action Group. He intimated that we still know so little about TMC114. Doesn't this scare you? I mean the report last week about tipranavir's weird and dangerous side effect of intracranial hemorrhaging sure scared me. Who knows what we don't know about TMC114. What do you think?
Answer from Nelson Vergel: TMC114 was approved with fewer than 500 patients in a controlled setting. It seems to be an effective drug for multidrug-resistant patients with a good side-effect profile so far, but we need to be cautious since the sample size is a lot smaller than that of previously approved drugs. Only time will tell what the "real-world" side effects of this drug are. Hopefully, we will see 48-week data soon.
Moderator: For more news and info about TMC114, check out: www.thebody.com/treat/tmc114.html.
Question from tigerguy: Is it OK to drink alcohol in modest amounts while on HAART or can this result in aberrant blood levels of one's HAART meds and consequently lead to drug resistance?
Answer from Nelson Vergel: It depends on what you call modest amounts. As you know, HAART can burden the liver in some patients; so drinking alcohol in large amounts may worsen this problem. Alcohol in moderate amounts (one to two drinks per day) may actually improve good cholesterol levels. So, moderation is key.
Question from anonymous: I developed resistance to nevirapine + lamivudine [brand name: Epivir; also known as 3TC] + stavudine [brand name: Zerit; also known as d4T] after over three years, so my doctor decided to add abacavir [brand name: Ziagen] to my regimen. My viral load became undetectable, but how long will it take before I develop resistance to the new combination? And is there any particular cause for the resistance?
Answer from Nelson Vergel: Your doctor "intensified" your regimen with one new drug combined with a failing regimen. It is very difficult to assess how long intensification can sustain viral load control. We are walking away from the intensification philosophy and focusing more on starting at least two active medications at the same time after resistance to a regimen occurs. Hopefully, you still have the protease, integrase and entry inhibitor classes available for you, if you do develop resistance to this regimen. I will caution you to discuss with your doctor the potential risks of stavudine for lipoatrophy and neuropathy.
Question from lalaland: In your view, is poor adherence the biggest factor in the development of resistance? Can you discuss other causes?
Answer from Nelson Vergel: Yes, poor adherence may be one of the main factors that predispose somebody's virus to develop resistance. However, poor absorption, liver metabolism, race and gender factors, body weight, medication history and pre-existing resistance, sub-optimal dosing and drug interactions may also cause blood levels of medications to be suboptimal. I know many people who had great adherence and then developed resistance in a few months. We need to be careful not to always try to find fault in the patient when resistance develops.
Question from anonymous: I read in the newspaper that a new pill is being approved this week that is an entire regimen in and of itself; it's Truvada and Sustiva combined. My question is: What's the big deal about this, if it's just a combination of two drugs we already use? Is the only difference that I'd be taking one less pill a day? Same side effects and everything?
Answer from Nelson Vergel: This is great news for people who are naive to medications and who are afraid of taking pills. However, for most of us in this chat room that have multidrug resistance, this new one-pill-a-day option provides little benefit. I hope the two companies collaborating on this formulation do the right thing and provide this pill at low cost to ADAP [AIDS Drug Assistance Programs], Medicare/Medicaid and developing countries. Issues with one of the components (Sustiva) and its use in people with a history of depression and in women of childbearing years should also be clearly explained to potential users of this convenient pill. Also, skipping doses of a three-drug pill may predispose someone to resistance in a faster way, so good adherence education must be provided.
Question from anonymous: My boyfriend will start a new regimen of only Fuzeon and TMC114 (Prezista) boosted with Norvir in two weeks. His T cells are around 45. He has done different resistance tests in the past and has come up resistant to everything at one time or another. His doctor said it is useless to give him any other meds since he has already shown resistance to everything. Using only two meds instead of three doesn't sound potent enough to me. Here in Italy, the clinic doesn't want to do another resistance test (too expensive and useless they say). Also, he was told that the new integrase inhibitor isn't available yet in Italy. What should he do -- take nothing and wait for three new drugs or take the two new drugs and hope for the best?
Answer from Nelson Vergel: For many people in multidrug resistance, salvage situations like this, starting at least two new agents has shown to be more effective than starting one new agent on top of a failing regimen. The benefits of waiting for a third agent that may provide an even better response should be measured against the probability of death or illness at the CD4 levels that your boyfriend has. Also, we may benefit from drugs to which our virus has developed resistance. For instance, I am using Combivir and Viread as a background even though I have resistance to them. Nucleosides have shown some benefits in decreasing replicating capacity of the virus even in people with people living with multidrug resistance.
Two new agents will be available in a few months in the U.S. and possibly Europe. The Merck integrase inhibitor and TMC 125 (a non-nuke) may be available in expanded access in a few months. Your boyfriend should talk to his doctor about this numbers' "waiting dilemma" to assess the pros and cons of starting two active agents now or waiting for three in a few months. Another unknown for most of us now is: How much will intensification with the integrase class benefit those who have not fully suppressed their virus on options like Prezista + Fuzeon?
Question from tigerguy: How often does HIV genotype testing need to be performed to assess for newly developed resistance? Before ever starting on HAART I had this testing done and had one mutation to the Sustiva class of drugs [NNRTIs]. Also, can drug levels themselves be monitored to assess for individual differences in drug metabolism?
Answer from Nelson Vergel: Many physicians nowadays are performing genotype tests in treatment-naive patients to find out if there is any preexisting transmitted resistance like in your case. Some studies have shown that up to 14 % of people who are newly diagnosed may have pre-existing resistance inherited from the person who infected them. So, first-line regimens may not work as well for them. After a patient reaches an undetectable viral load, there is no need for resistance testing. In my case, I have gotten genotype tests before starting a new regimen.
There is no consensus among clinicians in the United States about the clinical significance of therapeutic drug monitoring [TDM]. In some European countries, TDM seems to be more accepted as a means of assessing medication blood levels in people who are experiencing side effects or drug resistance if using protease inhibitors or non-nucleosides. The ACTG [AIDS Clinical Trials Group] is currently performing a study on TDM.
Moderator: More on this study can be found at: http://clinicaltrials.gov/ct/show/NCT00041769.
Question from Ted: How did you find a good HIV specialist? I mean, do you figure out your regimen yourself or do you have some doc that you really trust?
Answer from Nelson Vergel: The best way to find a good HIV doctor is to ask people online, support groups, nonprofit AIDS service organizations, etc [Check out The Body's extensive list of AIDS organizations around the world]. Once you set up the first appointment, it is your duty to ask the doctor basic questions about his philosophy and approach to treating not only HIV but also side effects related to HAART. I'm lucky to have a very experienced and progressive doctor who not only embraces pharmaceutical treatment but also complimentary therapies. However, it is up to you to keep up-to-date with information since most doctors are extremely busy. Keep in mind that your doctor's support staff is sometimes as important as the level of experience and "bedside manners" that the doctor may have. I know great doctors with poorly trained support staff that make office visits and follow ups a nightmare.
Question from anonymous: I would like to know your feeling about natural treatments. Have you ever tried them?
Answer from Nelson Vergel: I am a Latino man from South America, where our culture tends to be a lot more inclined to use herbs and natural therapies. However, after living with HIV for 23 years and using many products, I have developed a strong bias against unproven therapies for HIV control. I have also seen friends die because they only embraced natural therapies. I believe these therapies are complementary to HIV meds, not alternatives. However, I am a strong believer in the evidence of micronutrients, exercise, meditation, and good nutrition in maintaining health while living with HIV. Another thing that concerns me about some herbal products is the potential interaction with HIV medications (like the case of St. John's Wort and Crixivan). [For more on drug interactions, click here]
Question from anonymous: Have you heard of apple cider vinegar as an alternative treatment for HIV?
Answer from Nelson Vergel: Yes and all those claims are not based on any research or evidence. I would stay away from this. I am afraid that some people may be fooling themselves with stuff like this and not facing the fact that HIV medications may help them. I would also suggest you check with buyers clubs like the one in Houston [Houston Buyer's Club or New York [New York Buyer's Club] for more information on supplements and complementary therapies. They keep up with published data and try to only buy from companies with good quality control. Remember that the FDA does not regulate the supplement industry (and neither do we want them to).
Moderator: The Body has more info on complementary therapies at: www.thebody.com/dietnut/vitamins.html.
Question from Corey: Which micronutrients do you take and what evidence do you have that there are no interactions between them and your current meds?
Answer from Nelson Vergel: I take selenium as an important antioxidant shown to be deficient in people with HIV, carnitine and coenzyme Q10 for mitochondrial and nerve cell protection, and a potent multivitamin like SuperNutrition's Optipak. Unfortunately, we may never see interaction studies between most of the supplements and HIV medications. So, in a way, I am taking a calculated risk based on the potential benefits that these supplements have shown in several small HIV-related studies. I have never had high lipids, neuropathy, little lipodystrophy and other side effects common in HIV-positive people taking HIV meds. Whether this is due to my supplements or not is yet to be proven, but I have a strong believe that they may have helped. However, I caution everybody to talk to their doctor about any supplements that they are considering taking. Do not fall for the next scam or trend. Ask around and do research before spending your money and putting too much faith in claims that are not even backed with pilot studies. Both Tufts University and University of Miami have published good studies on micronutrients and HIV.
Question from anonymous: I am a 47-year-old female who has had HIV for about 15 years now. My first round of HIV drugs caused me to come down with lipodystrophy, and the pain in my legs at times can be unbearable. I've been on several series of Serostim [a brand of human growth hormone] and they have all helped, along with exercise. But this last time seems to be much harder on me for some reason. Is this normal? Why can't I just take Serostim indefinitely? Also, I read that oxandrolone [brand name: Oxandrin; an oral anabolic steroid] can restore muscle and fat tissue. Is this true, or will I have fat loss in my legs and butt forever? Would this anabolic steroid make my stomach even bigger?
Answer from Nelson Vergel: I am sorry that you are battling body changes like many of us have. Serostim has been shown to be effective at reducing internal abdominal fat, but it is very expensive, not approved for lipodystrophy yet, can cause joint pains and diabetes in some, and requires injections daily or two to three times a week. It can also cause a decrease in subcutaneous fat (lipoatrophy). But at lower doses of under 2 to 3 mg a day, it seems that many can tolerate it. Anabolic steroids like Nandrolone and Oxandrin can increase strength and lean body mass in HIV-positive men and women. But they can disrupt your hormonal balance, so they need to be administered by a doctor who has some experience with them and HIV-positive people. Anabolic steroids have not been shown to decrease visceral fat by much, and they may decrease subcutaneous fat. I have had good experience with them. I think they may help us compensate for the loss of fat mass in the limbs by increasing lean body mass there. Some of us may also have a muscular "steroid belly" due to increases in muscle and organ tissue in that area.
I think cardiovascular exercise and limiting your simple carbohydrate intake may show more promise in decreasing belly fat than anything else out there. But both options require commitment and adherence, two things that are difficult for many people. Avoiding certain HIV meds like Zerit and others that may cause insulin resistance may be something to consider.
I wish that some company would be interested in researching buttock restoration. Many people I talk to in my lectures have difficulty sitting for long periods of time due to extreme loss of tissue in their buttocks. Patients with money are flying to Mexico and Brazil to get their butts restored with unknown long term risks.
Moderator: You can learn much more about body-fat changes and related health problems by visiting: www.thebody.com/treat/lipodystrophy.html.
Question from anonymous: My husband is HIV positive. He has responded to all of his meds and has lived well with the virus for over 14 years. [However,] we were told that there was nothing left. He has been off meds since November 2005 with a promise from the doctor -- first in January, then March, and now again in July -- that a new drug will be available. I don't know how much longer he can wait. I am scared. He has lost so much weight, [he has] nose bleeds, [his] mental health is poor, and [his] memory is failing. I called today and spoke with the doctor's office, which said that TMC114 won't be available until August [TMC114 was approved on June 23, 2006]. What should we do? I have given up my job to be with him through this period. I don't want to give up hope.
Answer from Nelson Vergel: I'm assuming that your husband developed resistance to all available medications, including Fuzeon. A new protease inhibitor (Prezista) has recently been approved for people with multi-protease inhibitor resistance [for information on this new drug, click here]. There is also an integrase inhibitor (MK-0518) and a non-nucleoside (TMC 125) that should be available in expanded access in the next few months. Prezista plus these other drugs may provide a lot of hope for people like your husband. Also, people living with multiple drug resistance and declining CD4 cells and health should not be on long treatment interruptions. Dr. Deeks in San Francisco has shown that staying on simple nucleosides like Epivir on their own (called "partial treatment interruption") slows down the rate of CD4 cell decline and viral load increase in people living with multidrug resistance.
If you feel like your husband's doctor is not being aggressive enough about his treatment options, you may want to ask around to find another doctor who may have more access to research protocols and expanded access programs.
Question from anonymous: Why is it that I have been undetectable for three years already and my CD4 has only gone up a little? When I was diagnosed, my CD4 was 40; in February 2006 it went up to 74, but in May it went down to 62. Can you tell me what is going on, or maybe try to help me with what I can do to boost my CD4 count? My CD4 percentage is 7 percent.
Answer from Nelson Vergel: This is one of those puzzling questions. Some people have very small increases in CD4 cells with HAART. I am not sure how long you have been on HAART, though, and what meds you are taking. Sometimes it takes a long time to see small increases in CD4 cells. There is no consensus in the medical field whether the use of Interleukin-2 [generic name: aldesleukin; brand name: Proleukin; also known as IL-2, r-serHulL] in patients like you will have long-term benefits, but this is something that you may want to talk to your doctor about.
Moderator: Our site has a bit more info about Interleukin at: www.thebody.com/treat/interleu.html.
Question from anonymous: [I am] a newly diagnosed HIV-positive individual. Do you think that [via] constant changing of therapies [I can] prevent long-term toxicities? In essence, what I am asking is, should we constantly be changing up our regimens to keep the virus at bay, or do you think that doing so will cause future multidrug resistance? I do not know if any studies have been done to see whether this can be done.
Answer from Nelson Vergel: The key to success in treating our HIV is to find the best possible combination that will provide the longest and most sustainable response with the fewest side effects. With over 22 treatment options right now, we have more options to do so. After 10 years of HAART, clinicians have learned to choose the most effective and least toxic regimens. There has been very little research in sequencing and alternating different regimens to prevent long term toxicities while sustaining viral replication control.
Moderator: I'm afraid we only have time to answer one more question; my apologies again to everybody who submitted excellent questions that we couldn't get to today! I hope you'll consider using The Body's "Ask the Experts" area at www.thebody.com/experts.shtml to get the answers to your questions.
You can also join Nelson's discussion group for HIVers by sending a blank e-mail to pozhealth-subscribe@yahoogroups.com.
Question from tigerguy: What is the typical length a given regimen will be effective before resistance is developed to at least one of the drugs, assuming 100-percent compliance with the prescribed regimen?
Answer from Nelson Vergel: There is no way to predict length of response in patients. For instance, long-term follow-up studies on the use of Kaletra have shown that many people on this drug still have an undetectable viral load- after five years. For those with no resistance at baseline, this is an achievable reality. We definitely need long-term studies on this question.
Moderator: Our interactive chat on multidrug resistance has now ended. Nelson, thanks so much for taking the time to answer everyone's questions!
Nelson Vergel: I want to thank TheBody.com for giving me the opportunity to volunteer to share my experience with my fellow HIVers and thank all of you who have taken the time to be in this chat. There are lots of good things happening for us patients living with multidrug resistance. Stay tuned!!
Moderator: The pleasure's all ours, Nelson. :)Thank you all again. Have a good evening!
Post-Chat Questions
These questions were submitted before or during the chat, but, because of time limitations, Nelson did not have the chance to answer them before the live chat concluded.
Question: I am very allergic to even small doses of Norvir. I get horrible diarrhea, fatigue and bloating even with 100 mg a day of Norvir boosting in protease regimens. The new drugs Aptivus and Prezista require Norvir boosting. Please, please, tell me that there are drugs coming up with do not require Norvir.
Answer from Nelson Vergel: There is good news for you. There are three drugs currently in development that do not do not require Norvir. They are MRK 518, the Merck integrase inhibitor, TMC 125, Tibotec's second generation non-nucleoside and maraviroc (a CCR5 entry inhibitor). All of them may be available in the next few months in expanded access programs. I hope those three companies are looking ahead to allow the use of other's investigational agents (as long as they show no potentially negative interactions.)
Question from anonymous: My 14-year-old has multidrug resistance, even to drugs he has never taken. Genotype testing revealed that he has intermediate resistance to amprenavir [brand name: Agenerase] and tipranavir. He has been on treatment since age four and I can assure you that I have faithfully given him his meds as prescribed all the time. I can't access new drugs, but if I did what would I combine with them? Rescriptor [generic name: delavirdine] is the only other drug that he can respond to, but I have read some not so encouraging news about it. I am going out of my head with worry.
Answer from Nelson Vergel: I am assuming you live in the U.S. or Europe. It must be very stressful for you to have to worry about your son's health. You may want to talk to his doctor about how to construct a "holding regimen" with the few drugs that his genotype shows some sensitivity to, or about how to start him on new drugs like Prezista and Fuzeon, or about waiting for the integrase class to be available in a few months in expanded access or in a phase III study.
Question from anonymous: I am a clinician providing care and counseling for PLWHA [People Living With HIV/AIDS] in Uganda. This is a resource poor setting. Clinical assessment may not be enough to confirm multidrug resistance [MDR] in people on treatment. What other options can I use in order to confirm MDR in such a setting where sophisticated tests are just a mere dream?
Answer from Nelson Vergel: Measuring resistance in resource-limited locations is a problem. Assuming that adherence is not an issue, previous treatment history and a viral load increase may be the only way to "assume" drug resistance. Another huge issue is what treatment options patients have available in those settings after developing resistance to first- or second-line regimens. I would suggest that you post this very important question at TheBody.com's "Ask the Experts" forums.
Question from anonymous: I participated in your seminar in Chicago for HIV-positive gay men and I'm a big fan. My question is about neuropathy or that chronic "pins and needles" feeling I get in my right leg. I've been positive for four years and it's been with me since infection. My doctor is not very "on it" and I suppose I should seek out a neurologist, but I wondered in your experience if you found something effective or [know of] something new on the horizon I could seek out.
Answer from Nelson Vergel: Thanks. I love what I do! Neuropathy is one of those things that did not get better with HAART. Some people developed it after using d4T, ddI [brand name: Videx; also known generically as didanosine] or ddC [brand name: Hivid; also known generically as zalcitabine]; others can only attribute it to HIV. I would suggest that you do go to a neurologist who has experience in HIV-related neuropathy. We do not have a treatment specifically approved for this problem. Many doctors prescribe pain and anti-seizure medications to manage it. There is some growing research in the use of carnitine, an over-the-counter supplement, to improve nerve function [Dr. Keith Henry responded to a reader's question about these studies here].
Question from anonymous: I tested HIV positive in May 2006. Currently, I am not on any meds. I still feel okay, but don't know for how long. Should I wait until I am feeling ill, or is now the right time to visit my doctor for advice?
Answer from Nelson Vergel: You should see a doctor to see what your CD4 count and viral load are. That would help you and him/her determine if you should wait or start now with medications. Do not assume that since you feel OK, your numbers are good. Some people feel "OK" with low CD4 cells and others feel lousy with high ones, so it is hard to predict if you need treatment based on how you feel. There are many good once-a-day options with low pill counts. Soon we will have a one-pill-a-day option for people who do not have resistance to any medications [Atripla approved July 12, 2006].
Copyright © 2006 Body Health Resources Corporation. All rights reserved.
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This article was provided by The Body.
Transcript of The Body's Live Chat on Multidrug Resistance With Nelson Vergel
July 10, 2006
Following is the transcript of The Body's live chat on multidrug resistance, which took place on July 10, 2006, at 3:30 p.m. Eastern Time. The chat was moderated by The Body's editorial staff and hosted by HIV treatment advocate Nelson Vergel. This transcript has been edited for grammar and clarity. Additional follow-up information was obtained from the host after the chat's conclusion.
This is the seventh chat that The Body has moderated; to see transcripts of previous chats, click here.
Moderator: Thank you for coming to The Body's live, interactive chat on HIV treatment issues for people with multidrug resistance. We're about to get things started! A quick note before we get going: Please keep in mind that the information we provide in this chat is not meant to replace the attention or advice of a doctor or another health care professional. Make sure you consult with a qualified health care professional before making any dietary, drug, exercise or other lifestyle change!
Nelson, before we begin answering everyone's questions, why don't you take a few minutes to tell folks a bit about yourself?
Nelson Vergel: My name is Nelson Vergel. I have been positive for 23 years. Until recently, I have never had an undetectable viral load. I have been a victim of sequential (or virtual) monotherapy (adding a new agent to a failing regimen). I started AZT [brand name: Retrovir; also known generically as zidovudine] as monotherapy in the late 1980s. Treatment with individual nucleosides followed, and I subsequently developed resistance to each of them. [I was started on] saquinavir [brand names: Fortovase, Invirase] treatment in 1996, but due to its low absorption in my body, I developed resistance to it and to most protease inhibitors.
I tried Viramune [generic name: nevirapine] and Sustiva [generic name: efavirenz; also known by the brand name Stocrin] and also developed resistance to them pretty quickly. Next, I tried Kaletra [generic name: lopinavir/ritonavir] in combination with Invirase; this stabilized my CD4 cells in the 500 range for a few years. After 2002, my CD4 cells declined gradually while my viral load stayed in the 20,000-60,000 range, even with mega-HAART regimens (more than four drugs). I then started Fuzeon [generic name: enfuvirtide; also known as T-20] on top of my failing regimen, and it stabilized me for two years more.
Two months ago, my CD4 cells had dropped to 180 and my viral load was around 40,000. I joined the Merck integrase study and started Prezista [generic name: darunavir; also known as TMC114] at kept Viread [generic name: tenofovir] and Combivir [generic name: zidovudine/lamivudine; also known as AZT/3TC] in my background therapy. My viral load now is undetectable for the first time and my CD4s have gone up to 260. I am excited and hopeful.
I have been an HIV treatment activist since 1988. I have also been lucky to be part of the AIDS Treatment Activists Coalition. This has given me the opportunity to interact with pharmaceutical companies, researchers, the FDA [U.S. Food and Drug Administration], and key activists to learn a lot about drug development and give input into research studies. I am the founder of salvagetherapies.org, facialwasting.org, medibolics.com, and the largest HIV discussion group on the Internet (PozHealth at Yahoo.com). I am also the co-author of the book "Built to Survive." My main goal, currently, is to educate HIV-positive people living with multidrug resistance about current and future options, so that they avoid adding a single new active drug to a failing regimen, as this does not maximize their long-term chances for viral control and survival. For more information about my non-profit organization, PoWeR- Program for Wellness Restoration, go to powerusa.org.
Moderator: Thanks, Nelson -- and congrats on your successful new med regimen! Let's start the chat! Please feel free to submit any questions you have for today's speaker: Nelson Vergel, a leading patient advocate in the field of multidrug resistance.
Question from anonymous: Nelson thanks a lot for sharing your knowledge with us. I have nothing left that works for me. I took Fuzeon for eight months, but it stopped working. My T cells are 60 and my viral load is 80,000. My doctor wants me to start the new drug Prezista and start Fuzeon again. I am not sure what to do. What would you do, if you were me?
Answer from Nelson Vergel: I am sorry that you are going through the stress of trying to find new options to control your HIV. Luckily, we are about to have a few more options than [we have had] in the past few years. I would suggest that you talk to your doctor about running a genotype test for Fuzeon to see if there is still any activity to it for you. But chances are that you may already have resistance to it. Some clinicians also may argue that even if sensitivity to Fuzeon shows in your genotype test, it may actually be a case of "archived resistance" that may reemerge pretty quickly after you restart Fuzeon.
Luckily, we may have three new medications (Merck's integrase inhibitor [MK-0518], Tibotec's TMC 125 (etravirine- a non-nucleoside), and Pfizer's maraviroc [also known as UK-427,857], a CCR5 entry inhibitor) in expanded access in the next few months that we can use to avoid "virtual monotherapy" and to give us the luxury of starting two to three new agents at the same time. There are also two other products coming up in phase III studies soon: Gilead's integrase inhibitor [GS 9137] and Tanox's TNX-355 (an IV [intravenous] that will be administered every two weeks). These two phase III studies also will provide options with which to combine Prezista and/or Fuzeon. I hope that Merck, Tibotec and Pfizer will work together to allow the use of their drugs in each other's expanded access. This will be the first time in HIV history that we will have the luxury of three agents being available close to each other.
Your doctor will be able to help you determine if you should stay on a "holding pattern regimen" until you can start at least two new agents. It is a very difficult decision that needs to weigh your current symptoms and past CD4-decline trend.
Moderator: You can learn a bit more about Merck's integrase inhibitor MK-0518 by visiting: www.thebody.com/treat/mk0518.html.
Question from swhoutx025: Will I develop drug resistance even if I am vigilant and adherent to my current HAART therapy (Sustiva + Truvada [generic name: tenofovir/emtricitabine; also known as TDF/FTC])?
Answer from Nelson Vergel: In my 10 years of lecturing around the country, I have met many people who have been on their first regimen for many years. There is no reason why you should not be successful at keeping your viral load undetectable for a long time, if you are adherent to your meds.
Question from anonymous: Nelson, I hear that there is an oral Fuzeon coming out. Is that true and when? What new drugs are coming out in the next year? I have run out of everything and my T cells are low, but my doctor tells me to be patient.
Answer from Nelson Vergel: No, not really. Roche is investigating injectable fusion inhibitors that may be administered once a week, but this work is in very preliminary stages. Some people may confuse the oral CCR5 entry inhibitor class with fusion inhibitors, however. The medical and treatment advocacy community is anxiously waiting to see data from Pfizer's maraviroc study in treatment-experienced patients in the next few months. Maraviroc is an oral entry inhibitor that may work as an "add-on" to HAART in patients with multidrug resistance.
Question from anonymous: Nelson, I have resistance to all medications, including Fuzeon. My T cells are only 5 and my viral load is 80,000. I am very afraid of having a flare-up of my old CMV [cytomegalovirus]. I have a good doctor [who is up-to-date] with all the studies for salvage. He has offered to enter me in the DUET study of TMC125 [generic name: etravirine] or the Merck integrase study. I do not know what to do. I want to survive and get better. Do you know anything about these studies? Should I join or do something else?
Answer from Nelson Vergel: I am sorry that you are going through such a stressful dilemma. But, in a way, think about how many options you have now that you did not have just a few months ago! Tibotec's DUET studies (DUET 1 and 2) are being conducted in the hopes to get a new non-nuke, TMC125, approved. Fifty percent of patients will be randomized to ritonavir [brand name: Norvir]-boosted TMC114 + TMC125 + nukes with or without Fuzeon; the other 50 percent of patients will be enrolled in ritonavir-boosted TMC114 + placebo TMC125 + nukes with or without Fuzeon.
Since you have resistance to both nukes and Fuzeon, you may be exposed to only one "active" agent (TMC114) in the placebo arm. Tibotec will rollover anyone who does not have virologic control in the placebo arm at month six to open-label TMC125. From data in POWER 1 and 2 (the studies that got Prezista approved), we know that around 18 percent of patients with no active agents left achieved an undetectable viral load at week 24 with Prezista (this may or may not be similar to the response we may see in the DUET placebo arm).
As of mid July 2006, the DUET studies are almost fully enrolled. Tibotec will be providing TMC 125 in expanded access in a few months.
For those with very low CD4 cells, declining health, and no active agents left, Tibotec may provide TMC125 in an emergency IND (Investigational New Drug) program [which doctors can use to get access to an investigational drug] depending on the patient's clinical picture. This way, you may be able to construct a two-active drug regimen with Prezista + TMC125. However, your doctor has to justify to the company that you are not a good candidate for DUET due to your health and the risk of virtual monotherapy in the placebo arm. It is not a simple process since they have to agree to give you the drug, get your doctor to fill out two forms for the FDA, and get your doctor to get local IRB (institutional review board) approval for your application. More details on this is available at salvagetherapies.org.
In the Merck integrase study (BENCHMRK study to get MK-0518 approved), you have a 33 percent chance of being randomized to placebo MK-0518. Merck will rollover those in the placebo arm to treatment at week 16 if no virologic control is attained. You can use Prezista, nukes, non-nukes, and Fuzeon in this study. This study may be closed to enrollment soon since it has accrued really fast. We are hopeful that Merck will provide this drug in expanded access before the end of this year, which may give people an opportunity to construct a regimen with more than one active agent. Regimens like Prezista + MK-0518 + TMC 125 + nukes with or without Fuzeon will be a reality in the near future.
Moderator: The DUET studies that Nelson referred to are currently enrolling multidrug-resistant HIVers in the United States and several other countries. To learn more about these trials, visit: www.clinicaltrials.gov/ct/show/NCT00255099 and www.clinicaltrials.gov/ct/show/NCT00254046 (each trial has different testing sites, so check each one to see if it has a site near where you live or work).
Question from anonymous: Do you know much about the new "black box" warning that Aptivus [generic name: tipranavir] can cause "intracranial hemorrhage" or something like that? What does it mean, and should I be worried about it?
Answer from Nelson Vergel: The maker of Aptivus has reported 14 cases of intracranial hemorrhage events, including eight fatalities, in 6,840 HIV-1-infected individuals receiving Aptivus capsules in combination antiretroviral therapy in clinical trials (0.2 % of all patients in the study.) Many of the patients who experienced this problem had other medical conditions -- CNS [central nervous system] lesions, head trauma, recent neurosurgery, coagulopathy (when bleeding following an injury is prolonged and excessive), hypertension or alcohol abuse -- or were receiving concomitant medications, including anticoagulants and antiplatelet agents, that may have caused or contributed to these events. It also seems that this problem had been observed before in people with advanced disease taking other protease inhibitors in the past.
Boehringer Ingelheim is investigating this problem right now in more detail. Physicians have been informed to closely monitor patients who may have any of the risks factors mentioned. Aptivus is a protease inhibitor that has helped many patients with multiple protease resistance. Those who are benefiting from it should discuss this new information with their physicians, especially if they have any of the risks factors mentioned above. We will know more details about this in a few weeks, hopefully.
Moderator: You can read more about the tipranavir "black box" warning at: www.thebody.com/kaiser/2006/jul3_06/aptivus_warning.html.
Question from Dora: I was wondering if you read Rob Camp's analysis of TMC114 for Treatment Action Group. He intimated that we still know so little about TMC114. Doesn't this scare you? I mean the report last week about tipranavir's weird and dangerous side effect of intracranial hemorrhaging sure scared me. Who knows what we don't know about TMC114. What do you think?
Answer from Nelson Vergel: TMC114 was approved with fewer than 500 patients in a controlled setting. It seems to be an effective drug for multidrug-resistant patients with a good side-effect profile so far, but we need to be cautious since the sample size is a lot smaller than that of previously approved drugs. Only time will tell what the "real-world" side effects of this drug are. Hopefully, we will see 48-week data soon.
Moderator: For more news and info about TMC114, check out: www.thebody.com/treat/tmc114.html.
Question from tigerguy: Is it OK to drink alcohol in modest amounts while on HAART or can this result in aberrant blood levels of one's HAART meds and consequently lead to drug resistance?
Answer from Nelson Vergel: It depends on what you call modest amounts. As you know, HAART can burden the liver in some patients; so drinking alcohol in large amounts may worsen this problem. Alcohol in moderate amounts (one to two drinks per day) may actually improve good cholesterol levels. So, moderation is key.
Question from anonymous: I developed resistance to nevirapine + lamivudine [brand name: Epivir; also known as 3TC] + stavudine [brand name: Zerit; also known as d4T] after over three years, so my doctor decided to add abacavir [brand name: Ziagen] to my regimen. My viral load became undetectable, but how long will it take before I develop resistance to the new combination? And is there any particular cause for the resistance?
Answer from Nelson Vergel: Your doctor "intensified" your regimen with one new drug combined with a failing regimen. It is very difficult to assess how long intensification can sustain viral load control. We are walking away from the intensification philosophy and focusing more on starting at least two active medications at the same time after resistance to a regimen occurs. Hopefully, you still have the protease, integrase and entry inhibitor classes available for you, if you do develop resistance to this regimen. I will caution you to discuss with your doctor the potential risks of stavudine for lipoatrophy and neuropathy.
Question from lalaland: In your view, is poor adherence the biggest factor in the development of resistance? Can you discuss other causes?
Answer from Nelson Vergel: Yes, poor adherence may be one of the main factors that predispose somebody's virus to develop resistance. However, poor absorption, liver metabolism, race and gender factors, body weight, medication history and pre-existing resistance, sub-optimal dosing and drug interactions may also cause blood levels of medications to be suboptimal. I know many people who had great adherence and then developed resistance in a few months. We need to be careful not to always try to find fault in the patient when resistance develops.
Question from anonymous: I read in the newspaper that a new pill is being approved this week that is an entire regimen in and of itself; it's Truvada and Sustiva combined. My question is: What's the big deal about this, if it's just a combination of two drugs we already use? Is the only difference that I'd be taking one less pill a day? Same side effects and everything?
Answer from Nelson Vergel: This is great news for people who are naive to medications and who are afraid of taking pills. However, for most of us in this chat room that have multidrug resistance, this new one-pill-a-day option provides little benefit. I hope the two companies collaborating on this formulation do the right thing and provide this pill at low cost to ADAP [AIDS Drug Assistance Programs], Medicare/Medicaid and developing countries. Issues with one of the components (Sustiva) and its use in people with a history of depression and in women of childbearing years should also be clearly explained to potential users of this convenient pill. Also, skipping doses of a three-drug pill may predispose someone to resistance in a faster way, so good adherence education must be provided.
Question from anonymous: My boyfriend will start a new regimen of only Fuzeon and TMC114 (Prezista) boosted with Norvir in two weeks. His T cells are around 45. He has done different resistance tests in the past and has come up resistant to everything at one time or another. His doctor said it is useless to give him any other meds since he has already shown resistance to everything. Using only two meds instead of three doesn't sound potent enough to me. Here in Italy, the clinic doesn't want to do another resistance test (too expensive and useless they say). Also, he was told that the new integrase inhibitor isn't available yet in Italy. What should he do -- take nothing and wait for three new drugs or take the two new drugs and hope for the best?
Answer from Nelson Vergel: For many people in multidrug resistance, salvage situations like this, starting at least two new agents has shown to be more effective than starting one new agent on top of a failing regimen. The benefits of waiting for a third agent that may provide an even better response should be measured against the probability of death or illness at the CD4 levels that your boyfriend has. Also, we may benefit from drugs to which our virus has developed resistance. For instance, I am using Combivir and Viread as a background even though I have resistance to them. Nucleosides have shown some benefits in decreasing replicating capacity of the virus even in people with people living with multidrug resistance.
Two new agents will be available in a few months in the U.S. and possibly Europe. The Merck integrase inhibitor and TMC 125 (a non-nuke) may be available in expanded access in a few months. Your boyfriend should talk to his doctor about this numbers' "waiting dilemma" to assess the pros and cons of starting two active agents now or waiting for three in a few months. Another unknown for most of us now is: How much will intensification with the integrase class benefit those who have not fully suppressed their virus on options like Prezista + Fuzeon?
Question from tigerguy: How often does HIV genotype testing need to be performed to assess for newly developed resistance? Before ever starting on HAART I had this testing done and had one mutation to the Sustiva class of drugs [NNRTIs]. Also, can drug levels themselves be monitored to assess for individual differences in drug metabolism?
Answer from Nelson Vergel: Many physicians nowadays are performing genotype tests in treatment-naive patients to find out if there is any preexisting transmitted resistance like in your case. Some studies have shown that up to 14 % of people who are newly diagnosed may have pre-existing resistance inherited from the person who infected them. So, first-line regimens may not work as well for them. After a patient reaches an undetectable viral load, there is no need for resistance testing. In my case, I have gotten genotype tests before starting a new regimen.
There is no consensus among clinicians in the United States about the clinical significance of therapeutic drug monitoring [TDM]. In some European countries, TDM seems to be more accepted as a means of assessing medication blood levels in people who are experiencing side effects or drug resistance if using protease inhibitors or non-nucleosides. The ACTG [AIDS Clinical Trials Group] is currently performing a study on TDM.
Moderator: More on this study can be found at: http://clinicaltrials.gov/ct/show/NCT00041769.
Question from Ted: How did you find a good HIV specialist? I mean, do you figure out your regimen yourself or do you have some doc that you really trust?
Answer from Nelson Vergel: The best way to find a good HIV doctor is to ask people online, support groups, nonprofit AIDS service organizations, etc [Check out The Body's extensive list of AIDS organizations around the world]. Once you set up the first appointment, it is your duty to ask the doctor basic questions about his philosophy and approach to treating not only HIV but also side effects related to HAART. I'm lucky to have a very experienced and progressive doctor who not only embraces pharmaceutical treatment but also complimentary therapies. However, it is up to you to keep up-to-date with information since most doctors are extremely busy. Keep in mind that your doctor's support staff is sometimes as important as the level of experience and "bedside manners" that the doctor may have. I know great doctors with poorly trained support staff that make office visits and follow ups a nightmare.
Question from anonymous: I would like to know your feeling about natural treatments. Have you ever tried them?
Answer from Nelson Vergel: I am a Latino man from South America, where our culture tends to be a lot more inclined to use herbs and natural therapies. However, after living with HIV for 23 years and using many products, I have developed a strong bias against unproven therapies for HIV control. I have also seen friends die because they only embraced natural therapies. I believe these therapies are complementary to HIV meds, not alternatives. However, I am a strong believer in the evidence of micronutrients, exercise, meditation, and good nutrition in maintaining health while living with HIV. Another thing that concerns me about some herbal products is the potential interaction with HIV medications (like the case of St. John's Wort and Crixivan). [For more on drug interactions, click here]
Question from anonymous: Have you heard of apple cider vinegar as an alternative treatment for HIV?
Answer from Nelson Vergel: Yes and all those claims are not based on any research or evidence. I would stay away from this. I am afraid that some people may be fooling themselves with stuff like this and not facing the fact that HIV medications may help them. I would also suggest you check with buyers clubs like the one in Houston [Houston Buyer's Club or New York [New York Buyer's Club] for more information on supplements and complementary therapies. They keep up with published data and try to only buy from companies with good quality control. Remember that the FDA does not regulate the supplement industry (and neither do we want them to).
Moderator: The Body has more info on complementary therapies at: www.thebody.com/dietnut/vitamins.html.
Question from Corey: Which micronutrients do you take and what evidence do you have that there are no interactions between them and your current meds?
Answer from Nelson Vergel: I take selenium as an important antioxidant shown to be deficient in people with HIV, carnitine and coenzyme Q10 for mitochondrial and nerve cell protection, and a potent multivitamin like SuperNutrition's Optipak. Unfortunately, we may never see interaction studies between most of the supplements and HIV medications. So, in a way, I am taking a calculated risk based on the potential benefits that these supplements have shown in several small HIV-related studies. I have never had high lipids, neuropathy, little lipodystrophy and other side effects common in HIV-positive people taking HIV meds. Whether this is due to my supplements or not is yet to be proven, but I have a strong believe that they may have helped. However, I caution everybody to talk to their doctor about any supplements that they are considering taking. Do not fall for the next scam or trend. Ask around and do research before spending your money and putting too much faith in claims that are not even backed with pilot studies. Both Tufts University and University of Miami have published good studies on micronutrients and HIV.
Question from anonymous: I am a 47-year-old female who has had HIV for about 15 years now. My first round of HIV drugs caused me to come down with lipodystrophy, and the pain in my legs at times can be unbearable. I've been on several series of Serostim [a brand of human growth hormone] and they have all helped, along with exercise. But this last time seems to be much harder on me for some reason. Is this normal? Why can't I just take Serostim indefinitely? Also, I read that oxandrolone [brand name: Oxandrin; an oral anabolic steroid] can restore muscle and fat tissue. Is this true, or will I have fat loss in my legs and butt forever? Would this anabolic steroid make my stomach even bigger?
Answer from Nelson Vergel: I am sorry that you are battling body changes like many of us have. Serostim has been shown to be effective at reducing internal abdominal fat, but it is very expensive, not approved for lipodystrophy yet, can cause joint pains and diabetes in some, and requires injections daily or two to three times a week. It can also cause a decrease in subcutaneous fat (lipoatrophy). But at lower doses of under 2 to 3 mg a day, it seems that many can tolerate it. Anabolic steroids like Nandrolone and Oxandrin can increase strength and lean body mass in HIV-positive men and women. But they can disrupt your hormonal balance, so they need to be administered by a doctor who has some experience with them and HIV-positive people. Anabolic steroids have not been shown to decrease visceral fat by much, and they may decrease subcutaneous fat. I have had good experience with them. I think they may help us compensate for the loss of fat mass in the limbs by increasing lean body mass there. Some of us may also have a muscular "steroid belly" due to increases in muscle and organ tissue in that area.
I think cardiovascular exercise and limiting your simple carbohydrate intake may show more promise in decreasing belly fat than anything else out there. But both options require commitment and adherence, two things that are difficult for many people. Avoiding certain HIV meds like Zerit and others that may cause insulin resistance may be something to consider.
I wish that some company would be interested in researching buttock restoration. Many people I talk to in my lectures have difficulty sitting for long periods of time due to extreme loss of tissue in their buttocks. Patients with money are flying to Mexico and Brazil to get their butts restored with unknown long term risks.
Moderator: You can learn much more about body-fat changes and related health problems by visiting: www.thebody.com/treat/lipodystrophy.html.
Question from anonymous: My husband is HIV positive. He has responded to all of his meds and has lived well with the virus for over 14 years. [However,] we were told that there was nothing left. He has been off meds since November 2005 with a promise from the doctor -- first in January, then March, and now again in July -- that a new drug will be available. I don't know how much longer he can wait. I am scared. He has lost so much weight, [he has] nose bleeds, [his] mental health is poor, and [his] memory is failing. I called today and spoke with the doctor's office, which said that TMC114 won't be available until August [TMC114 was approved on June 23, 2006]. What should we do? I have given up my job to be with him through this period. I don't want to give up hope.
Answer from Nelson Vergel: I'm assuming that your husband developed resistance to all available medications, including Fuzeon. A new protease inhibitor (Prezista) has recently been approved for people with multi-protease inhibitor resistance [for information on this new drug, click here]. There is also an integrase inhibitor (MK-0518) and a non-nucleoside (TMC 125) that should be available in expanded access in the next few months. Prezista plus these other drugs may provide a lot of hope for people like your husband. Also, people living with multiple drug resistance and declining CD4 cells and health should not be on long treatment interruptions. Dr. Deeks in San Francisco has shown that staying on simple nucleosides like Epivir on their own (called "partial treatment interruption") slows down the rate of CD4 cell decline and viral load increase in people living with multidrug resistance.
If you feel like your husband's doctor is not being aggressive enough about his treatment options, you may want to ask around to find another doctor who may have more access to research protocols and expanded access programs.
Question from anonymous: Why is it that I have been undetectable for three years already and my CD4 has only gone up a little? When I was diagnosed, my CD4 was 40; in February 2006 it went up to 74, but in May it went down to 62. Can you tell me what is going on, or maybe try to help me with what I can do to boost my CD4 count? My CD4 percentage is 7 percent.
Answer from Nelson Vergel: This is one of those puzzling questions. Some people have very small increases in CD4 cells with HAART. I am not sure how long you have been on HAART, though, and what meds you are taking. Sometimes it takes a long time to see small increases in CD4 cells. There is no consensus in the medical field whether the use of Interleukin-2 [generic name: aldesleukin; brand name: Proleukin; also known as IL-2, r-serHulL] in patients like you will have long-term benefits, but this is something that you may want to talk to your doctor about.
Moderator: Our site has a bit more info about Interleukin at: www.thebody.com/treat/interleu.html.
Question from anonymous: [I am] a newly diagnosed HIV-positive individual. Do you think that [via] constant changing of therapies [I can] prevent long-term toxicities? In essence, what I am asking is, should we constantly be changing up our regimens to keep the virus at bay, or do you think that doing so will cause future multidrug resistance? I do not know if any studies have been done to see whether this can be done.
Answer from Nelson Vergel: The key to success in treating our HIV is to find the best possible combination that will provide the longest and most sustainable response with the fewest side effects. With over 22 treatment options right now, we have more options to do so. After 10 years of HAART, clinicians have learned to choose the most effective and least toxic regimens. There has been very little research in sequencing and alternating different regimens to prevent long term toxicities while sustaining viral replication control.
Moderator: I'm afraid we only have time to answer one more question; my apologies again to everybody who submitted excellent questions that we couldn't get to today! I hope you'll consider using The Body's "Ask the Experts" area at www.thebody.com/experts.shtml to get the answers to your questions.
You can also join Nelson's discussion group for HIVers by sending a blank e-mail to pozhealth-subscribe@yahoogroups.com.
Question from tigerguy: What is the typical length a given regimen will be effective before resistance is developed to at least one of the drugs, assuming 100-percent compliance with the prescribed regimen?
Answer from Nelson Vergel: There is no way to predict length of response in patients. For instance, long-term follow-up studies on the use of Kaletra have shown that many people on this drug still have an undetectable viral load- after five years. For those with no resistance at baseline, this is an achievable reality. We definitely need long-term studies on this question.
Moderator: Our interactive chat on multidrug resistance has now ended. Nelson, thanks so much for taking the time to answer everyone's questions!
Nelson Vergel: I want to thank TheBody.com for giving me the opportunity to volunteer to share my experience with my fellow HIVers and thank all of you who have taken the time to be in this chat. There are lots of good things happening for us patients living with multidrug resistance. Stay tuned!!
Moderator: The pleasure's all ours, Nelson. :)Thank you all again. Have a good evening!
Post-Chat Questions
These questions were submitted before or during the chat, but, because of time limitations, Nelson did not have the chance to answer them before the live chat concluded.
Question: I am very allergic to even small doses of Norvir. I get horrible diarrhea, fatigue and bloating even with 100 mg a day of Norvir boosting in protease regimens. The new drugs Aptivus and Prezista require Norvir boosting. Please, please, tell me that there are drugs coming up with do not require Norvir.
Answer from Nelson Vergel: There is good news for you. There are three drugs currently in development that do not do not require Norvir. They are MRK 518, the Merck integrase inhibitor, TMC 125, Tibotec's second generation non-nucleoside and maraviroc (a CCR5 entry inhibitor). All of them may be available in the next few months in expanded access programs. I hope those three companies are looking ahead to allow the use of other's investigational agents (as long as they show no potentially negative interactions.)
Question from anonymous: My 14-year-old has multidrug resistance, even to drugs he has never taken. Genotype testing revealed that he has intermediate resistance to amprenavir [brand name: Agenerase] and tipranavir. He has been on treatment since age four and I can assure you that I have faithfully given him his meds as prescribed all the time. I can't access new drugs, but if I did what would I combine with them? Rescriptor [generic name: delavirdine] is the only other drug that he can respond to, but I have read some not so encouraging news about it. I am going out of my head with worry.
Answer from Nelson Vergel: I am assuming you live in the U.S. or Europe. It must be very stressful for you to have to worry about your son's health. You may want to talk to his doctor about how to construct a "holding regimen" with the few drugs that his genotype shows some sensitivity to, or about how to start him on new drugs like Prezista and Fuzeon, or about waiting for the integrase class to be available in a few months in expanded access or in a phase III study.
Question from anonymous: I am a clinician providing care and counseling for PLWHA [People Living With HIV/AIDS] in Uganda. This is a resource poor setting. Clinical assessment may not be enough to confirm multidrug resistance [MDR] in people on treatment. What other options can I use in order to confirm MDR in such a setting where sophisticated tests are just a mere dream?
Answer from Nelson Vergel: Measuring resistance in resource-limited locations is a problem. Assuming that adherence is not an issue, previous treatment history and a viral load increase may be the only way to "assume" drug resistance. Another huge issue is what treatment options patients have available in those settings after developing resistance to first- or second-line regimens. I would suggest that you post this very important question at TheBody.com's "Ask the Experts" forums.
Question from anonymous: I participated in your seminar in Chicago for HIV-positive gay men and I'm a big fan. My question is about neuropathy or that chronic "pins and needles" feeling I get in my right leg. I've been positive for four years and it's been with me since infection. My doctor is not very "on it" and I suppose I should seek out a neurologist, but I wondered in your experience if you found something effective or [know of] something new on the horizon I could seek out.
Answer from Nelson Vergel: Thanks. I love what I do! Neuropathy is one of those things that did not get better with HAART. Some people developed it after using d4T, ddI [brand name: Videx; also known generically as didanosine] or ddC [brand name: Hivid; also known generically as zalcitabine]; others can only attribute it to HIV. I would suggest that you do go to a neurologist who has experience in HIV-related neuropathy. We do not have a treatment specifically approved for this problem. Many doctors prescribe pain and anti-seizure medications to manage it. There is some growing research in the use of carnitine, an over-the-counter supplement, to improve nerve function [Dr. Keith Henry responded to a reader's question about these studies here].
Question from anonymous: I tested HIV positive in May 2006. Currently, I am not on any meds. I still feel okay, but don't know for how long. Should I wait until I am feeling ill, or is now the right time to visit my doctor for advice?
Answer from Nelson Vergel: You should see a doctor to see what your CD4 count and viral load are. That would help you and him/her determine if you should wait or start now with medications. Do not assume that since you feel OK, your numbers are good. Some people feel "OK" with low CD4 cells and others feel lousy with high ones, so it is hard to predict if you need treatment based on how you feel. There are many good once-a-day options with low pill counts. Soon we will have a one-pill-a-day option for people who do not have resistance to any medications [Atripla approved July 12, 2006].
Copyright © 2006 Body Health Resources Corporation. All rights reserved.
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This article was provided by The Body.
Thursday, July 06, 2006
HIV Lecture in Houston - July 12
Open to patients and clinicians
Date: Wednesday, July 12
Time : 6:30 pm - 8:30 pm
Place: Lovett Inn ( http://www.lovettinn.com/main.php )
Speakers: Dr Shannon Schrader and Nelson Vergel
TOPICS:
1- Updated review of HIV pipeline products
2- How to best maximize the effects of Prezista, the newly approved protease inhibitor for multi-protease resistant virus
3- What is virtual monotherapy and what are its risks?
4- What are the best predictors of treatment response in patients with multidrug resistant virus?
5- Information on Fuzeon's needle free injection device (BOSS Study)
6- Integrase Inhibitors- Why the hype?
7- Are oral entry inhibitors safe and effective? What do the studies so far show?
8- Gene therapy in HIV- An update
9- Questions and Answers
Reply to this email or nelsonvergel@yahoo.com to reserve a seat since space is very limited.
For those who cannot attend, there will be a live chat at thebody.com on July 10th at 2:30 pm Central. Questions can be sent in now. A full transcript will be available after the chat. For more information:
http://www.thebody.com/submit/?/chat/main_071006.html
Date: Wednesday, July 12
Time : 6:30 pm - 8:30 pm
Place: Lovett Inn ( http://www.lovettinn.com/main.php )
Speakers: Dr Shannon Schrader and Nelson Vergel
TOPICS:
1- Updated review of HIV pipeline products
2- How to best maximize the effects of Prezista, the newly approved protease inhibitor for multi-protease resistant virus
3- What is virtual monotherapy and what are its risks?
4- What are the best predictors of treatment response in patients with multidrug resistant virus?
5- Information on Fuzeon's needle free injection device (BOSS Study)
6- Integrase Inhibitors- Why the hype?
7- Are oral entry inhibitors safe and effective? What do the studies so far show?
8- Gene therapy in HIV- An update
9- Questions and Answers
Reply to this email or nelsonvergel@yahoo.com to reserve a seat since space is very limited.
For those who cannot attend, there will be a live chat at thebody.com on July 10th at 2:30 pm Central. Questions can be sent in now. A full transcript will be available after the chat. For more information:
http://www.thebody.com/submit/?/chat/main_071006.html
Wednesday, June 28, 2006
Dr Shannon Scharder and Nelson Vergel talk about multidrug resistance, Prezista, Fuzeon, Integrase
http://www.prnewswire.com/broadcast/24683/consumer.shtml
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