Lipodystrophy Treatments

by Nelson Vergel

September 2006

Some HIV+ people experience unwanted body shape changes and metabolic problems. These problems are often grouped together and referred to as lipodystrophy. However, when talking about treatments for lipodystrophy, it is better to look at these problems individually.
The body changes that have been seen in HIV+ people can include:
Fat gain (lipohypertrophy) in the stomach, breasts, or back of the neck (“buffalo hump”); women are more likely to experience fat gain in the breasts
Fat loss (lipoatrophy) in the arms, legs, butt, or face (sunken cheeks)
The metabolic problems that have been seen in HIV+ people can include:
An inability to handle sugar properly (insulin resistance or diabetes)
High levels of fat (lipids), like cholesterol and triglycerides, in the blood
Some treatments can help with certain aspects of lipodystrophy, but nothing has been proven to resolve all the problems.

Treatments for Fat Gain

No one is really sure what causes lipohypertrophy or fat gain. Sometimes fat gain happens when a person puts on weight because of lack of exercise or getting older. However, fat gain may also be linked to the use of HIV drugs including protease inhibitors or other HIV treatments.

Human Growth Hormone
One treatment that is currently being looked at in research studies for HIV-related fat gain is human growth hormone (hGH).This hormone is naturally produced in the human body. hGH is not approved for lipodystrophy-related fat gain at this time and will not be covered by insurance for this use.
In HIV studies, hGH has been shown to reduce belly fat at doses of two to three milligrams (mg) a day, injected under the skin. It is expensive, costing up to $3,000 a month. Bodybuilders report that it works better if used in combination with exercise, testosterone, or anabolic steroids, but HIV-related combination studies are lacking.
The main side effects are joint aches, water retention, diabetes, and pancreatic enzyme increases. It may also increase the chances of tumor growth and decrease fat under the skin (which can increase lipoatrophy in other parts of the body). Right now, there is a research study using Serostim (a brand of hGH) with Avandia (a diabetes drug) to see if this combination can prevent diabetes and lipoatrophy problems.

Exercise
Several small studies have shown the effectiveness of cardiovascular (aerobic) exercise and resistance (weight) training in reducing belly fat.
Cardiovascular exercise is any activity that increases your heart rate to the level required for increased metabolism. It decreases body fat, improves insulin sensitivity, decreases blood pressure, and improves aerobic capacity. Twenty to 40 minutes a day should be enough, as long as you sweat. Some studies show that wearing a pedometer and aiming at 10,000 steps a day (around three miles) can provide enough exercise to decrease lipids and fat.
Examples of cardiovascular exercise include walking at a fast pace, jogging, roller blading, dancing, and climbing stairs. If you have access to a gym you can also use treadmills, elliptical machines, and stair climbers.
Resistance training consists of using weights to improve muscle strength and growth. Examples include push-ups, squats, and the use of free weights and machines at the gym. Aim for one hour sessions three to four times a week. The key is consistency. Three sets per body part with a weight that only allows a maximum of ten repetitions per set has been shown in studies to be an effective way to increase muscle growth and strength.
Exercise can be very healthy, but it is a good idea to check with your doctor if you are going to start an exercise program to make sure you don’t over do it.

Fat Burners
These products are not recommended and not proven to be effective in HIV+ people. They usually contain stimulants that decrease appetite and the ability to sleep. They can also increase blood pressure and cardiovascular disease.

Growth Hormone or Testosterone Precursors
These products are not proven to increase hormone levels.

Testosterone
Studies evaluating the use of testosterone to decrease waist size in HIV+ men have shown conflicting results. A study recently published showed that testosterone gel at 10 mg a day is effective in increasing energy and decreasing waist size in HIV+ men. Another unpublished study showed no benefit. Testosterone may decreases fat in both the belly and under the skin. It has the potential of worsening lipoatrophy in some patients.
Testosterone replacement in men is given by injections every two weeks (200 mg is a common dose). Testosterone gels (Androgel, Testim) or compounded gels and patches (Androderm) are also available. Women require lower doses and are usually prescribed customized gels made in compounding pharmacies.

Liposuction
Ultrasound-assisted liposuction of the buffalo hump has been successfully used to remove fat accumulation in the back of the neck. Hump liposuction has had a good track record of reimbursement by third party payers when doctors justify it due to pain or sleep disorders. In some cases, however, the hump may return after a few months. Liposuction of fat deep in the belly is a more difficult and risky procedure.

Treatments for Fat Loss
Some HIV drugs may cause fat loss under the skin (lipoatrophy), including Zerit (stavudine or d4T) and Retrovir (zidovudine or AZT/ZDV). To lower the risk of fat loss, consider using other drugs in the same class if possible, such as Viread (tenofovir), Ziagen (abacavir), Emtriva (emtricitabine or FTC), and Epivir (lamivudine or 3TC).
Studies show that those who switch from Zerit or Retrovir to Viread or Ziagen tend to regain some fat under the skin. However, this process may take a long time or it may not be evident for those who have more severe cases of lipoatrophy.
While lipoatrophy can occur in the arms, legs, and butt, fat loss in the face is probably most difficult for HIV+ people. This can make you look older and sicker than you are and cause embarrassment and low self esteem. There are some treatments available for facial wasting.

Sculptra
This is the first facial reconstruction product approved in the U.S. for HIV-related lipoatrophy. The product is injected under the skin by a trained professional, usually a dermatologist or plastic surgeon. It requires three to six sessions with 21 days between each session and a touch-up every year. The product costs $980 per session plus the doctor fee ($250-$500 per session). Dermik, the manufacturer, has a good patient assistance program. For more information, go to www.sculptra.com .

Radiesse
This product received FDA approval for use in the correction of facial lipoatrophy in HIV+ people. Radiesse contains man-made calcium hydroxylapatite, a substance found in bones and teeth. It is currently approved in the U.S. for various uses, including reconstructive surgery and dentistry, and has a good safety record. Radiesse is considered to be a temporary filler, meaning that its cosmetic benefits decrease over time, usually within a few years of receiving the injections. It can be very expensive at up to $3,000 per office visit. The company will offer patient assistance but details are unknown at the present.

Bioalcamid
This product is not approved in the U.S., but is available in Europe, Mexico, Canada, and other countries. Patients have been going to Mexico and Canada to get it. It is a permanent filler and usually requires one or two sessions at a total cost of $4,500. No patient assistance program is available in the U.S.

Silikon 1000
This product is not approved for lipoatrophy, but is commonly used by doctors ”off label” for this purpose. Unlike the way silicone was used in the past, this product is injected in very small quantities (micro droplets) which require anywhere from three to six sessions depending on the severity of the facial wasting. The average cost per session is around $700.

PMMA
This product is not approved in the U.S. Patients have been traveling to Rio de Janeiro and Mexico to obtain it. It is a permanent solution that usually requires two sessions. Total cost in Rio can range from $1,000 to 2,000. (PMMA has also been used in Rio to treat lipoatrophy of the butt.)
The long-term effects of these treatments are unknown. Some treatments are not permanent and results can vary. They can also be costly, and many insurance companies will not provide coverage. If you are planning on using a treatment, and especially if you plan to go outside of the U.S. for treatment, check with the product’s manufacturer to make sure your provider has been properly trained to perform the procedure.

Treatments for Metabolic Problems

High lipids (cholesterol and triglycerides) can increase your chances of having heart problems. Switching HIV medications may help, however some people have elevated lipids without being on these medications. Moderately elevated lipid levels can be addressed by decreasing your intake of fats, exercising regularly, and losing weight if you are overweight.
If the triglyceride or bad cholesterol levels (LDL) are not reduced with diet and exercise, or if they are too high to start with, your doctor may prescribe lipid-lowering drugs called statins and/or fibrates. Some cholesterol medications interact with HIV drugs, so have your doctor review all your medications before prescribing anything.
Many people who take HIV medications also have high levels of blood sugar. This might be caused by insulin resistance, which in some cases may lead to diabetes. If you have been told you are insulin resistant, or have family members who are diabetic, discuss your risk factors with your doctor.
You can reduce your risk of developing diabetes by maintaining an appropriate body weight, exercising, and eating foods that are low in saturated fat – but not too low in overall fat. Serious cases of insulin resistance can be treated with medication. These medications are also being studied to see if they can reduce other aspects of lipodystrophy.
Glucophage (metformin) has been shown to decrease belly fat alone and in combination with exercise. The main side effects include appetite suppression and diarrhea. Glucophage can also worsen lipoatrophy.
Avandia (rosiglitazone) has been shown to increase fat under the skin in those patients that have stopped Zerit or Retrovir in some studies. (It does not improve lipoatrophy in people still taking those drugs.) It can also increase belly fat, cause water retention, and increase triglycerides.
Actos (pioglitazone) seems to have the same effects as Avandia without the increases in triglycerides.

Nutrition
Very few studies have been performed to look at the effect of nutrition on lipodystrophy. One study showed that those patients who ate more soluble fiber tended to have lower incidence of lipodystrophy. Soluble fiber sources include fruits like oranges and apples, several vegetables, and oatmeal. Lowering the amount of sugars and simple carbohydrates has also been shown in some studies to decrease triglycerides.
Proper protein intake is key to sustaining lean body mass in HIV. Most dieticians agree that three to six smaller meals a day that contain vegetables, lean sources of protein, good fats, and soluble fiber are essential for healthy body composition.

Supplements

Omega 3 Oils
Oil derived from salmon has been shown to decrease triglycerides at a capsule dose of 2,000 mg – 3,000 mg a day. It is preferred to find sources that are free of heavy metals. Freezing the capsules tends to minimize burping and the fishy after taste.
Nucleomaxx (Uridine)
Nucleomaxx has been shown to increase subcutaneous fat in small short term studies in those taking Zerit or Retrovir. However, it can also increase belly fat and is expensive. It is not widely available in the U.S., although a study will soon be enrolling at the AIDS Clinical Trials Group (ACTG) sites. More information is available at http://aactg.org or http://www.Nucleomaxx.com.
Carnitine
Small studies show decreases in cholesterol and triglycerides in HIV + patients. Typical doses range from 2,000 mg – 3,000 mg a day. It can be purchased over the counter or by prescription (Carnitor).

Taking Care of Yourself
Some body shape changes and metabolic problems have been linked with heart disease and strokes in HIV+ people. To minimize the risk of heart disease and/or stroke:
Get checked and, if needed, treated for high blood pressure
Eat a healthy diet
Get regular exercise
Give up smoking
Lipodystropy can be a very distressing condition that affects how you feel about yourself. Speak to your doctor if you are experiencing any symptoms. Some of the treatments described above may help. Do not make any changes to your medication regimen without your doctor’s guidance.

1
Chow, D. C, et. al. (2006). Metabolic complications of HIV therapy. HIV InSite Knowledge Base Chapter: Retrieved July 2006 from http://hivinsite.ucsf.edu/InSite?page=kb-03-02-10
©2003-2006 The Well Project, Inc. A Not For Profit Corporation.

Fundariser-POZ CRUISE

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.

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.

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

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

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

# # #

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

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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

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.

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

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.