This press release comes from Paul Stalbaum, the organizer:
I am very excited to announce to you our plans for our Annual Poz Cruise Retreat open to all people living with HIV and of course, our friends and family.
This truly unique travel experience combines the perfect blend of socialization and educational aspects. Imagine your self sailing on a luxurious cruise ship over clear blue seas with a horizon that just never seems to end. Visit exotic tropical islands that allow us to relax on white powdery beaches and swim warm crystal clear azure blue waters. Want something more adventurous? Why not see majestic ancient Mayan ruins, rapel in steamy tropical jungles or swim with the dolphins?
This year’s cruise sails from Miami, Florida on October 28 and returns on November 4. We will have the privilege to visit Grand Cayman Island, Belize, Roatan (Honduras), and the golden Mayan Coast of Mexico. Rate begin at an unbelievably low rate of $399.00 per person plus tax for an inside cabins. Balcony cabins are available for just $655.00 per person. These rates are inclusive of all meals, nightly entertainment, private cocktail parties and other social events as well as our informative lectures and panel discussions by HIV specialists.
In years past, we have had many friendships and relationships develop. Several couples are together today because they met on our trips.
A portion of the proceeds collected will be donated to several HIV organizations as a means to raise funds for needy people in the U.S, as well as underdeveloped nations which health care is deplorable
Please do think of joining as we expect a large turn of for the Tenth Annual cruise which just happens to sail over Halloween!!!
Please visit www.positivecruise.com for details and photos or do feel free to call me at the number listed below.
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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: ....
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Exhorbitant Price New Hepatitis C Drug
Fair Pricing Coalition Condemns Gilead Sciences on the High Price of New Hepatitis C Drug Sovaldi™...
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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...
Thursday, January 18, 2007
Saturday, January 06, 2007
Comments on current expanded access programs
Comments from N Vergel about using these meds in combination:
1- MK 518 (integrase inhibitor) cannot be used yet with TMC 125 ( a non nucleoside) until Tibotec and Merck finish their interaction studies. Too bad it is taking this long!
2- Maraviroc ( a R5 coreceptor antagonist) can only be used for those who have a purely R5 tropic virus. You will need a test to determine that when applying to the expanded access program. Pfizer will cover the cost for that test. If you have a R5/X4 mixed or dual tropic virus, or a X4 only virus, you will not be allowed into the program. It is impossible to predict wich tropism your virus will have without testing for it, although people with longer term infection tend to have more X4 tropic virus than those in earlier stages.
3- Try to start 3 active meds when you start any new regimen. Ask your doctors to show you your genotype and/or phenotype test and discuss it with her before proceeding. Try to avoid a two active agent combo if you can wait for three. Be on the look out for any baseline resistance to Aptivus or Prezista. Just because you have never taken those two meds, it does not mean that you do not have resistance to them. Message: a new medication may not necessarily mean it is an "active" medication to fight your virus.
4- TMC 125 cannot be used with Aptivus ( a protease inhibitor). Also, you cannot use TMC 125 with Sustiva or Viramune. There is another product coming this year in phase III called TMC 278 (another non nuke) that may be more effective than TMC 125. If you develop resistance to TMC 125 , you may have diminished response to TMC 278. Keep that in mind in deciding when to start or to wait for later if you can.
5- Maraviroc can be used with both MK 518 and TMC 125. The Maraviroc program will start next month (Feb) in many countries
6- Other medications that can be used with either of these meds are: Fuzeon, Prezista, Aptivus, all nucleosides, and non nukes (for non TMC 125 combos)
7- MK 518 blood levels can increase when used with Reyataz. No one knows if this translates to a more durable response in the long term (after 48 weeks). So far, MK 518 seems to have a very good side effect profile
8- Remember that doctors and research nurses do not get reimbursed for their time when helping you get into most expanded access programs. Some doctors chose not to participate because of that. Try to find a doctor who has the manpower needed for all the paperwork required for these programs. It is difficult sometimes to find out who these doctors are since most companies refuse to list them to avoid upsetting non-EAP doctors. Pfizer and Tibotec are now doing a little better when it comes to helping cover manpower costs associated with these pre-approval expanded access programs than Meck is.
This info is from the FDA:
MK-0158, TMC125, and Maraviroc Now Available Through Expanded Access
In the September 15, 2006, At-a-Glance newsletter, AIDSinfo highlighted two anti-HIV medications available through expanded access. The Food and Drug Administration's expanded access programs provide patients with limited treatment options a way to add investigational medications to their treatment regimen. Now, in addition to MK-0158 and TMC125, a third anti-HIV medication has been made available through expanded access: maraviroc.
Maraviroc is a CCR5 antagonist. CCR5 is a protein found on the surface of certain immune cells that the HIV virus uses to enter the cell. CCR5 antagonists inhibit HIV from entering immune cells.
MK-0158, TMC125, and maraviroc are expected to be approved in 2007. Learn more about the Food and Drug Administration's expanded access and expedited approval processes for HIV/AIDS therapies.
1- MK 518 (integrase inhibitor) cannot be used yet with TMC 125 ( a non nucleoside) until Tibotec and Merck finish their interaction studies. Too bad it is taking this long!
2- Maraviroc ( a R5 coreceptor antagonist) can only be used for those who have a purely R5 tropic virus. You will need a test to determine that when applying to the expanded access program. Pfizer will cover the cost for that test. If you have a R5/X4 mixed or dual tropic virus, or a X4 only virus, you will not be allowed into the program. It is impossible to predict wich tropism your virus will have without testing for it, although people with longer term infection tend to have more X4 tropic virus than those in earlier stages.
3- Try to start 3 active meds when you start any new regimen. Ask your doctors to show you your genotype and/or phenotype test and discuss it with her before proceeding. Try to avoid a two active agent combo if you can wait for three. Be on the look out for any baseline resistance to Aptivus or Prezista. Just because you have never taken those two meds, it does not mean that you do not have resistance to them. Message: a new medication may not necessarily mean it is an "active" medication to fight your virus.
4- TMC 125 cannot be used with Aptivus ( a protease inhibitor). Also, you cannot use TMC 125 with Sustiva or Viramune. There is another product coming this year in phase III called TMC 278 (another non nuke) that may be more effective than TMC 125. If you develop resistance to TMC 125 , you may have diminished response to TMC 278. Keep that in mind in deciding when to start or to wait for later if you can.
5- Maraviroc can be used with both MK 518 and TMC 125. The Maraviroc program will start next month (Feb) in many countries
6- Other medications that can be used with either of these meds are: Fuzeon, Prezista, Aptivus, all nucleosides, and non nukes (for non TMC 125 combos)
7- MK 518 blood levels can increase when used with Reyataz. No one knows if this translates to a more durable response in the long term (after 48 weeks). So far, MK 518 seems to have a very good side effect profile
8- Remember that doctors and research nurses do not get reimbursed for their time when helping you get into most expanded access programs. Some doctors chose not to participate because of that. Try to find a doctor who has the manpower needed for all the paperwork required for these programs. It is difficult sometimes to find out who these doctors are since most companies refuse to list them to avoid upsetting non-EAP doctors. Pfizer and Tibotec are now doing a little better when it comes to helping cover manpower costs associated with these pre-approval expanded access programs than Meck is.
This info is from the FDA:
MK-0158, TMC125, and Maraviroc Now Available Through Expanded Access
In the September 15, 2006, At-a-Glance newsletter, AIDSinfo highlighted two anti-HIV medications available through expanded access. The Food and Drug Administration's expanded access programs provide patients with limited treatment options a way to add investigational medications to their treatment regimen. Now, in addition to MK-0158 and TMC125, a third anti-HIV medication has been made available through expanded access: maraviroc.
Maraviroc is a CCR5 antagonist. CCR5 is a protein found on the surface of certain immune cells that the HIV virus uses to enter the cell. CCR5 antagonists inhibit HIV from entering immune cells.
MK-0158, TMC125, and maraviroc are expected to be approved in 2007. Learn more about the Food and Drug Administration's expanded access and expedited approval processes for HIV/AIDS therapies.
FDA Approves Radiesse for Facial Lipoatrophy
In late December, the U.S. Food and Drug Administration (FDA) approved Radiesse, a new injectable therapy for the treatment of facial fat loss (lipoatrophy) in people with HIV; Radiesse was also approved as a cosmetic treatment for moderate-to-severe facial wrinkles and folds.
Radiesse, manufactured by BioForm Medical, contains a synthetic material that stimulates collagen production. Another product, Sculptra (poly-L-acetic acid), is also approved for treating lipoatrophy in HIV positive people.
Radiesse is not a permanent treatment, but is expected to last at least several months, and possibly as long as a few years.
Following is the letter from the FDA announcing the approval:
Radiesse Approved for Facial Lipoatrophy by FDA
On December 22, 2006, the Food and Drug Administration approved Radiesse, an injectable (under the skin) implant to restore or correct signs of facial lipidatrophy [lipoatrophy], or fat loss, in people with human immunodeficiency virus (HIV).
Radiesse, a sterile, semi-solid cohesive implant consisting of synthetic calcium hydroxylapatite suspended in a gel carrier, is a medical device. It is already approved for use as a tissue marker, for treatment of vocal fold insufficiency, and to correct certain dental defects.
The safety and effectiveness of Radiesse for the treatment of facial lipoatrophy was evaluated in a prospective, open-label, multi-center study of 100 patients with human immunodeficiency virus and facial lipoatrophy. Study subjects were at least 18 years of age, HIV positive, with a CD4 count >250 cells/mm3 and viral load <5000 copies/mL, had been receiving HAART therapy for a minimum of 3 years, and had HIV-associated facial lipoatrophy that was a grade 2, 3, or 4 on the Facial Lipoatrophy Severity Scale. The study population consisted predominantly of multi-ethnic, non-smoking males (94% male) with a mean age of 48 years. Forty-four percent (44%) of patients were Black, Hispanic or Asian. Fifty-six percent (56%) percent were Caucasian.
Patients received an initial treatment (initial injection and an additional injection at 1 month as needed). Six months later, all patients were assessed for the need for a touch up injection. Effectiveness was assessed at 3, 6 and 12 months from initial treatment by means of a Global Aesthetic Improvement Scale (GAIS) rating, cheek skin thickness measurements, and patient satisfaction assessment. Safety was assessed by the recording of adverse events through 12
months.
All treatments were performed with a 25 gauge, 1 and one-half inch needle. Mean initial treatment volumes were 4.8 mL for the initial treatment and 1.8 mL at 1 month if necessary (85% of patients were treated at 1 month). At 6 months, the mean touch up volume was 2.4 mL (89% of patients). Four percent (4%) of patients received only one treatment, 18% of patients received a total of two treatments, and 78% of patients received a total of three treatments. No patient received more than three treatments.
Mean left cheek thickness measurements at baseline was 4.7 mm (N=100). At 3 months, the mean thickness was 7.3 mm (N=100), representing an increase of 2.6 mm from baseline, with P-Value = 0.0001. At 6 months the mean thickness was 7.1 mm (N=97), representing an increase of 2.4 mm from baseline, with a P-Value = 0.0001.
Mean cheek thickness at baseline for the right cheek was 4.9 mm (N=100). At 3 months, the mean thickness was 8.0 mm (N=100), representing an increase of 2.1 mm from baseline, with a P-Value of 0.0001. At 6 months the mean thickness was 7.5 mm (N=97), representing an increase of 2.7 mm from baseline, with a P-Value of 0.0001.
The most common adverse events reported were temporary edema (swelling), ecchymosis (bruising), erythema (reddening) and/or pain at the injection site.
The calcium hydroxylapatite (CaHA) particles in Radiesse can be seen in X-rays and CT Scans. It is important that patients inform their doctor and other health care professionals that they have had Radiesse injected in the face. In a radiographic study of 58 patients, there was no indication that Radiesse potentially masked abnormal tissues or was interpreted as tumors in CT Scans.
Radiesse is a product of BioForm Medical Inc., of Franksville, WI.
01/05/07
Sources
Food and Drug Administration. Radiesse Approved for Facial Lipoatrophy by FDA. Announcement.
Bioform, Inc. BioForm Announces FDA Approval of Radiesse Facial Filler For Two New Aesthetic Applications. Press Release. December 27, 2006.
www.radiesse.com
In late December, the U.S. Food and Drug Administration (FDA) approved Radiesse, a new injectable therapy for the treatment of facial fat loss (lipoatrophy) in people with HIV; Radiesse was also approved as a cosmetic treatment for moderate-to-severe facial wrinkles and folds.
Radiesse, manufactured by BioForm Medical, contains a synthetic material that stimulates collagen production. Another product, Sculptra (poly-L-acetic acid), is also approved for treating lipoatrophy in HIV positive people.
Radiesse is not a permanent treatment, but is expected to last at least several months, and possibly as long as a few years.
Following is the letter from the FDA announcing the approval:
Radiesse Approved for Facial Lipoatrophy by FDA
On December 22, 2006, the Food and Drug Administration approved Radiesse, an injectable (under the skin) implant to restore or correct signs of facial lipidatrophy [lipoatrophy], or fat loss, in people with human immunodeficiency virus (HIV).
Radiesse, a sterile, semi-solid cohesive implant consisting of synthetic calcium hydroxylapatite suspended in a gel carrier, is a medical device. It is already approved for use as a tissue marker, for treatment of vocal fold insufficiency, and to correct certain dental defects.
The safety and effectiveness of Radiesse for the treatment of facial lipoatrophy was evaluated in a prospective, open-label, multi-center study of 100 patients with human immunodeficiency virus and facial lipoatrophy. Study subjects were at least 18 years of age, HIV positive, with a CD4 count >250 cells/mm3 and viral load <5000 copies/mL, had been receiving HAART therapy for a minimum of 3 years, and had HIV-associated facial lipoatrophy that was a grade 2, 3, or 4 on the Facial Lipoatrophy Severity Scale. The study population consisted predominantly of multi-ethnic, non-smoking males (94% male) with a mean age of 48 years. Forty-four percent (44%) of patients were Black, Hispanic or Asian. Fifty-six percent (56%) percent were Caucasian.
Patients received an initial treatment (initial injection and an additional injection at 1 month as needed). Six months later, all patients were assessed for the need for a touch up injection. Effectiveness was assessed at 3, 6 and 12 months from initial treatment by means of a Global Aesthetic Improvement Scale (GAIS) rating, cheek skin thickness measurements, and patient satisfaction assessment. Safety was assessed by the recording of adverse events through 12
months.
All treatments were performed with a 25 gauge, 1 and one-half inch needle. Mean initial treatment volumes were 4.8 mL for the initial treatment and 1.8 mL at 1 month if necessary (85% of patients were treated at 1 month). At 6 months, the mean touch up volume was 2.4 mL (89% of patients). Four percent (4%) of patients received only one treatment, 18% of patients received a total of two treatments, and 78% of patients received a total of three treatments. No patient received more than three treatments.
Mean left cheek thickness measurements at baseline was 4.7 mm (N=100). At 3 months, the mean thickness was 7.3 mm (N=100), representing an increase of 2.6 mm from baseline, with P-Value = 0.0001. At 6 months the mean thickness was 7.1 mm (N=97), representing an increase of 2.4 mm from baseline, with a P-Value = 0.0001.
Mean cheek thickness at baseline for the right cheek was 4.9 mm (N=100). At 3 months, the mean thickness was 8.0 mm (N=100), representing an increase of 2.1 mm from baseline, with a P-Value of 0.0001. At 6 months the mean thickness was 7.5 mm (N=97), representing an increase of 2.7 mm from baseline, with a P-Value of 0.0001.
The most common adverse events reported were temporary edema (swelling), ecchymosis (bruising), erythema (reddening) and/or pain at the injection site.
The calcium hydroxylapatite (CaHA) particles in Radiesse can be seen in X-rays and CT Scans. It is important that patients inform their doctor and other health care professionals that they have had Radiesse injected in the face. In a radiographic study of 58 patients, there was no indication that Radiesse potentially masked abnormal tissues or was interpreted as tumors in CT Scans.
Radiesse is a product of BioForm Medical Inc., of Franksville, WI.
01/05/07
Sources
Food and Drug Administration. Radiesse Approved for Facial Lipoatrophy by FDA. Announcement.
Bioform, Inc. BioForm Announces FDA Approval of Radiesse Facial Filler For Two New Aesthetic Applications. Press Release. December 27, 2006.
www.radiesse.com
Friday, November 24, 2006
HIV Lectures in December 2006
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
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
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
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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
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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:
*************************************************
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
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.
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.
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.
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