MEDICARE EXPANDS COVERAGE FOR TREATING FACIAL LIPODYSTROPHY SYNDROME IN PEOPLE LIVING WITH HIV

MEDICARE NEWS

For Immediate release Contact: CMS Office of Media Relations

March 23, 2010 (202) 690-6145

MEDICARE EXPANDS COVERAGE FOR TREATING FACIAL LIPODYSTROPHY SYNDROME IN PEOPLE LIVING WITH HIV

The Centers for Medicare & Medicaid Services (CMS) today announced its decision to cover facial injections for Medicare beneficiaries who experience symptoms of depression due to the stigmatizing appearance of severely hollowed cheeks resulting from the drug treatment for Human Immunodeficiency Virus (HIV). Today’s decision is effective immediately.

Facial lipodystrophy (LDS) is a localized loss of fat from the face, causing an excessively thin appearance in the cheeks. In some cases, facial LDS may be a side effect of certain kinds of medications (antiretroviral therapies) that individuals receive as part of an HIV infection treatment regimen.

The facial LDS can leave people living with HIV looking gaunt and seriously ill, which may stigmatize them as part of their HIV-infection status. Individuals who take these medications and experience facial LDS side effects may suffer psychological effects related to a negative self-image. These effects may lead people living with HIV to discontinue their antiretroviral therapies. The new decision allows for treatment of individuals who experience symptoms of depression due to the appearance changes from facial LDS.

The injections included in today’s coverage decision are “fillers” that have been approved by the U.S. Food & Drug Administration (FDA) to be injected under the skin in the face to help fill out its appearance specifically for treatment of facial LDS. Data show that these injections can improve patient self-image, relieve symptoms of depression, and may lead to improved compliance with anti-HIV treatment.

“Today’s decision marks an important milestone in Medicare’s coverage for HIV-infection therapies,” said Barry M. Straube, M.D., CMS Chief Medical Officer and Director of the Agency’s Office of Clinical Standards & Quality. “Helping people living with HIV improve their self-image and comply with anti-HIV treatment can lead to better quality of life and, ultimately, improve the quality of care that beneficiaries receive.”

The final decision is posted on the CMS Web site athttp://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=234.

Strive To Thrive While Growing Older With HIV

By Dennis McMillan Published: February 11, 2010

Nelson Vergel. Photo by Rink. Positive Force will present “Survivor Health Wisdom: Strive to Thrive While Growing Older with HIV” on Wednesday, Feb. 17, 6:30-9:30 p.m. at the San Francisco LGBT Community Center, 1800 Market and Octavia Streets. Join Nelson Vergel, author of Built to Survive, for the latest information on lipoatrophy, combating premature aging, and much more. A light dinner will be provided. To take advantage of the fact that Vergel will be in the Bay Area for a conference, Positive Force scheduled this event on the third Wednesday of the month. Twice annually, Positive Force produces a community health forum on a hot button issue. “Survivor Health Wisdom...” is a Positive Force community health forum.In this instance, they decided to do a forum on HIV and aging. The face of HIV changes with each passing day. For example, thanks to treatment advances, many people living with HIV today are living longer lives. Along with longer lives come the usual health concerns: increased risks for heart disease, non-HIV related cancers, bone loss, decreased mental function, etc. However, a plethora of recent research has clearly demonstrated that people living with HIV are suffering from accelerated aging; sometimes their minds and bodies manifest problems decades earlier than their HIV-negative counterparts. Consequentially, researchers, medical providers, treatment advocates, and HIV-positive people alike are trying to figure out how to conquer this new phase of living with HIV. Many community forums on HIV and aging involve doctors and other socio-medical professionals speaking clinically, and providing the same information, from the same point of view, time and time again. Positive Force decided to move in a different direction. They invited Vergel, a man who has lived with HIV for more than two decades and who is an internationally renowned treatment advocate, to discuss HIV and aging concerns from a peer perspective. Vergel has traveled the world talking about living and thriving with HIV; has written books on the topic; and has been featured in numerous publications for his expertise and perspective. Participants who attend the forum will benefit from Vergel’s unique perspective, presentation style, and lots of information. He will present the latest treatment information, both clinical and practical, for a range of subjects, including but not limited to lipodystrophy/ lipoatrophy, accelerated aging of both mind and body, and sexual health. Forum attendees will walk away with a better handle on how to deal with problems they may already be facing and how to prevent new problems associated with HIV and aging. Vergel is a 27-year HIV survivor, Venezuelan, retired chemical engineer, lecturer and author of Built to Survive, founder of the Body Positive Wellness Clinic in Houston, and treatment activist involved in research advocacy. Bay Times interviewed him recently. “I am the founder of pozhealth at yahoogroups.com, the largest online health discussion group, and serve as an expert at thebody.com, the HIV web site with the largest reach in HIV related health issues,” he said. “I have provided over 600 lectures since 1994 in English and Spanish. I am a member of the DHHS HIV Treatment Guidelines Panel. I have presented in many conferences about issues related to living with HIV.” What is different about what he does is his being able to lecture in layman terms by blending the latest research data with a patient perspective. He spoke of the hot topics in HIV in the next five years. “The search for a cure using stem cell and immune based therapy research will become more important as well as how to deal with long term effects of HIV medications on aging, frailty, cognitive function, bone density, frailty, body changes, and others,” said Vergel. “Combating stigma and dealing with challenges in funding will be essential to controlling the spread of this epidemic.” Vergel provides a unique angle to patients. He speaks in their language about the latest research findings on facial lipoatrophy options, cardiovascular health, sexual dysfunction, hormonal balance, exercise and nutrition, latest HIV medications for those with limited treatment options, side effect management, and many other issues that are important to patients.

Survivor Health Wisdom: Lecture in Orange County on March 9, 2010

Time: March 9, 2010 from 5pm to 8pm
Location: Dave and Busters, Irvine Spectrum
Street: 71 Fortune Dr.
City/Town: Irvine, CA
Website or Map: http://www.nelsonvergel.com/
Phone: 949.452.0888
Event Type: educational, forum
Organized By: Shanti Orange County

More information :http://shantioc.ning.com/events/big-7-series-nelson-vergel

Lecture: Survivor Health Wisdom: Strive To Thrive While Growing Older With HIV

STOP AIDS Project's Positive Force Presents "Survivor Health Wisdom: Strive To Thrive While Growing Older With HIV" on Wed, February 17 6:30-9:30 pm at the LGBT Community Center in San Francisco.

Join Nelson Vergel, author of Built to Survive, for the latest information on: Lipoatrophy, Combating Premature Aging, and MUCH MORE!!! A light dinner will be provided.

This evening's event is part of Positive Force's ongoing series "Healthy Minds Healthy Bodies" occurring on the third Wed of every month. For more information about Positive Force, this series or to RSVP to this month's event, contact Justin Jones at 575-0150, x 250 or jjones@stopaids.org.

Background:

The face of HIV changes with each passing day. For example, thanks to treatment advances, many people living with HIV today are living longer lives. Along with longer lives comes the usual health concerns: increased risks for heart disease, non-HIV related cancers, bone loss, decreased mental function, etc. However, a plethora of recent research has clearly demonstrated that people living with HIV are suffering from accelerated aging; sometimes their minds and bodies manifest problems decades earlier than their HIV-negative counterparts. Consequentially, researchers, medical providers, treatment advocates, and HIV-positive people alike are trying to figure out how to conquer this new phase of living with HIV.

Many community forums on HIV & Aging involve doctors and other socio-medical professionals speaking clinically, and providing the same information, from the same point of view, time and time again. Positive Force decided to move in a different direction. We invited Nelson Vergel, a man who has lived with HIV for more than two decades and who is an internationally renowned treatment advocate, to discuss HIV & Aging concerns from a peer perspective. Nelson has traveled the world talking about living and thriving with HIV, has written books on the topic, and has been featured in numerous publications for his expertise and perspective.

Participants who attend will benefit from Nelson's unique perspective, presentation style, and gobs of information. Nelson will present the latest treatment information, both clinical and practical, for a range of subjects, including but not limited to lipodystrophy/lipoatrophy, accelerated aging of both mind and body, and sexual health. Forum attendees will walk away with a better handle on how to deal with problems they may already be facing and how to prevent new problems associated with HIV & Aging.

FDA denies approval to long acting testosterone injections

Endo's drug is Nebido, a long acting injectable (testosterone undecanoate) , that has been available in Europe, Mexico, and many countries for years. It requires injections every three to four mouths instead of every week or two. Too bad the FDA made this decision.

This shows how difficult it is getting drugs approved now at the FDA with review panels that do not know much about the science (review panel members cannot have any conflict of interests and be part of any data review panels for any companies,which excludes a lot of the experts in the field). Anaphylactic reactions are common side effects with all approved testosterone injectables due to bad injection technique, so it is amazing that they stopped this approval based on a side effect that is well known with currently available testosterone products in the United States. Common symptoms of anaphylactic reactions with testosterone injections are cough and dizziness that subside after a few minutes. It is believed that this happens when testosterone enters the blood stream and ends up in the lungs (injections are meant to form a "pocket" for slow release in the muscle. Some people may inject in a blood vessel and have anaphylactic reactions). I have had this reaction and found a quick solution to it: breathe into a paper bag until the cough stops.

Nelson

http://www.reuters.com/article/americasMergersNews/idUSN038783120091203

NEW YORK, Dec 3 (Reuters) - U.S. health regulators declined to approve Endo Pharmaceuticals Holdings Inc's (ENDP.O) drug for low testosterone, requesting more information about rare but serious side effects, the specialty drugmaker said on Thursday, sending its shares down nearly 4 percent.

The U.S. Food and Drug Administration wants information about anaphylactic reactions following injection of the drug, and about events when a poor injection technique leads to oil leaking into the lung, causing coughing.

In its so-called complete response letter, the agency also said Endo's proposed strategy to mitigate risks for the drug, Aveed, was not sufficient.

Endo said it was evaluating the FDA letter. The drug is sold outside the United States by Germany's Bayer AG (BAYGn.DE) and is available in more than 50 countries under the brand name Nebido. Endo licenses Aveed from Bayer.

Jefferies & Co analyst Corey Davis said Endo may choose to end its development of the drug if it cannot resolve the FDA's concerns.

"It's hard for us to imagine what the company could do to satisfy FDA concerns over exceedingly rare events that we would guess are not even product-specific in the first place," Davis said in a research note.

However, Davis said consensus estimates for Aveed sales had been "relatively modest" at $94 million by 2012.

An Endo spokesman said it was not yet clear what the next steps for the product would be. "Our goal is to work closely with the agency," the spokesman, Kevin Wiggins, said.

Aveed was one of the main products Endo acquired earlier this year in its $370 million purchase of Indevus Pharmaceuticals, a deal designed to expand its product line beyond pain treatments.

"It clearly casts a cloud on their ability to make acquisitions," said Jim Molloy, an analyst with Caris & Co. "They made it very clear they are looking to acquire more things. This one didn't go so well, so there's going to be some scrutiny on what the next one will be."

Low testosterone, also known as hypogonadism, is linked to symptoms such as fatigue, loss of muscle mass and decreased libido, and there is increasing evidence of an association with conditions such as diabetes and cardiovascular disease, according to Endo.

The Aveed action marks the second regulatory setback for Endo in as many months related to a testosterone product. In October the FDA delayed approval of Endo's Fortesta, a gel for men with low testosterone.

In September the FDA extended its review of Aveed by three months.

Endo shares fell 86 cents, or 3.8 percent, to $21.56 in afternoon trading on Nasdaq.

Men’s Health Lecture- Two Experts Share their Knowledge

Nov. 24, 2009- Houston, TX – A group of wellness-related non-profits, Houston Buyers Club, LIVE consortium, and Program for Wellness Restoration, have collaborated to present a comprehensive Men’s Health lecture at the United Way in Houston, Texas on December 15, 2009. Dr. Michael Scally, an expert on hormone replacement in men, and Nelson Vergel, an international speaker and author on health and wellness, will present on the following: all you need to know about testosterone replacement therapy, sports nutrition, exercise, micronutrient supplementation, and other therapies to improve lean body composition and metabolism, sexual function, energy levels, mood and general quality of life.

When asked why there is a need for this lecture, Fred Walters, director of the Houston Buyers Club, said: “This is a rare opportunity to hear two experts on topics that affect men in every stage of their development from adolescents through old age. There is a huge need for good clinical information about health and wellness and the Houston Buyers Club is proud to part of this program.”

Dr Michael Scally is a progressive physician who has treated hundreds of men with hormone imbalances. He is the author of the book “Anabolic Steroids - A Question of Muscle: Human Subject Abuses in Anabolic Steroid Research”, available on amazon.com. His education includes a double degree major in Chemistry (1975) and Life Sciences (1975) from the Massachusetts Institute of Technology (M.I.T.) located in Cambridge, MA. From 1975-1980, Dr. Scally researched and published investigations on neurotransmitter relationships while at the M.I.T. Division of Brain Sciences & Neuroendocrinology. While a part of the prestigious Health Sciences & Technology Program, a collaboration of M.I.T. and Harvard Medical School, Dr. Scally was involved and participated in the earliest studies detailing the role of tryptophan, serotonin, and depression. In June 1980, Dr. Scally was awarded a Doctorate of Medicine, M.D. by Harvard Medical School. His professional memberships include The Endocrine Society and the American Association of Clinical Endocrinologists (AACE).

Nelson Vergel, a chemical engineer and wellness expert, is the co-author of the book "Built to Survive", the founder of the Body Positive Wellness Clinic in Houston, and an expert speaker on exercise, nutrition, testosterone replacement, metabolism, sexual function, and therapies to increase lean body mass and decrease fat. He has provided over 500 lectures in the past 15 years in the U.S. and overseas. He provides patient-friendly information accessible to anyone.

“We are truly fortunate to have these two amazing experts join forces to present this lecture on Men’s Health Issues”, said Beau Miller, President and Founder of LIVE consortium, a wellness-based educational non -profit. “Historically, this lecture topic is clouded by misinformation and confusion - specifically testosterone replacement. Not so, however, with a presentation by Dr. Scally or Nelson Vergel. Every man in Houston would benefit greatly by attending this free lecture”, added Miller.

The lecture will be held on December 15, 2009 at 6 pm at the United Way located at 50 Waugh Drive Houston, Texas 77007. Seats are limited and reservations are encouraged. Light snacks will be provided. Please email: lecturereservation@gmail.com with the number of people in your party.

Exercise: The Best Therapy for Managing Side Effects

Exercise: The Best Therapy for Managing Side Effects

How to Stay Active and Energetic

By Michael Mooney and Nelson Vergel

September/October 2009

There are many benefits of exercise in HIV disease. Besides the evident improved self-image, energy level, and mental outlook, several research studies performed with HIV-positive people have found the following clinical benefits in body composition and metabolism.

Exercise produces improved muscle function, increased body dimensions and mass, and strength when used alone.^1,2

It may reduce trunk (belly) fat mass in patients with HIV lipodystrophy.³

It increases muscle mass and decreases LDL (bad cholesterol) when combined with testosterone in eugonadal men (men with normal testosterone) with wasting.⁴

It increases build-up of lean tissue and strength gain when combined with oxandrolone (Oxandrin, an oral anabolic) in eugonadal men with wasting.⁵

Muscle hypertrophy (enlargement), induced by resistance training, may decrease triglyceride levels in the blood of hypertriglyceridemic (those with high triglycerides), HIV-positive men being treated with antiviral therapy.⁶

Acute exercise does not have a deleterious effect on HIV replication in adults with high viral loads.⁷

Moderate physical activity may slow HIV disease progression.⁸

Exercise is associated with significant improvement in mood and overall distress, as well as a significant increase in body cell and lean body mass.⁹

Exercise can increase bone density in men and women.¹⁰

Testosterone and resistance exercise promote gains in body weight, muscle mass, muscle strength, and lean body mass in HIV-positive men experiencing weight loss and low testosterone levels.¹¹

Exercise training resulted in a substantial improvement in aerobic function while immune indices were essentially unchanged. Quality of life markers improved significantly with exercise.¹²

Getting Started

Before you start an exercise program, there are some things to consider. First, get your blood pressure, heart rate, weight, body dimensions, fasting cholesterol, triglycerides, and blood sugar measured. Your doctor should be able to advise you if you are capable of exercising without health if you can.

If you feel tired and weak, start walking every day to your best ability. Walking can help increase energy levels to enable you to start a more intensive exercise program later on when you're feeling better. Using a cheap pedometer to measure your daily steps is useful. Try to reach 10,000 steps a day since that has been associated with good cardiovascular health and fat loss.

There are two types of exercise: resistance (or weight) training and cardiovascular (or aerobic) exercise. Resistance training uses weights to induce muscle growth. Cardiovascular exercise improves the way your body uses oxygen and increases metabolism so that you can burn fat and lower bad cholesterol and blood sugar.

Do low-impact aerobic exercise three to four times a week. Exercising for 20-40 minutes by walking fast, bike riding, going up the stairs, using a stationary bike, elliptical trainer, or treadmill will increase your aerobic capacity, help to burn fat, and decrease cholesterol, triglycerides, and blood sugar. Jogging should only be an option if you have very strong joints and no problems with neuropathy. Do not do aerobic exercise if you are losing weight involuntarily or if you are tired or recovering from illness. Some people worry that cardiovascular (aerobic) exercise can increase fat wasting (lipoatrophy), but this fear is unfounded, in our opinion.

Recommendations

Train with weights and machines three times a week for one hour. Starting with machines is the safest way until you get familiar with the exercises. As you feel more confident and strong, bring in free weight exercise (hopefully with the help of a workout buddy). As you get stronger, increase your weights in every exercise. Exercise one body part per week, and do three exercises per body part. One light warm-up set and two heavier sets of eight to ten repetitions (to momentary muscular failure, meaning until you can not do another rep) are enough for each exercise. If you do not have access to a gym, do push ups on the floor and squats holding books or large bottles full of water at home. As long as you are "resisting" your own body weight, you are doing resistance exercise. You can also get an exercise ball and follow this great home-based workout: www.myfit.ca/exercisedatabase/search.asp?muscle=Home&equipment=yes.

For examples of other exercises you can do at home, visit http://weboflife.nasa.gov/exerciseandaging/chapter4_strength.html.

For great resistance exercises at the gym, visit: www.myfit.ca/exercisedatabase/weight_lifting_exercises.asp.

Important Things to Remember

• Learn how to do each exercise correctly and concentrate on using strict form to get the most out of exercise and prevent injuries.
• Make sure your muscles are warm before targeting them with more challenging weights. Warm them up with a light, high-repetition exercise set.
• Don't use your body to add momentum; cheating this way takes work away from the targeted muscles. Use a deliberate speed to increase the effectiveness of the movement.
• Use a full range of motion on all exercises. Feel the muscle stretch at the bottom and go for a momentary peak contraction at the top. Don't go too fast!
• Warm up before you work out and stretch afterwards to prevent injury. Briefly stretch the major muscle groups before your training. Th is helps flexibility and muscle recovery. For stretching routines, go tohttp://weboflife.nasa.gov/exerciseandaging/chapter4_stretching.html.
• Feel the muscles working by keeping your head in what you're doing. Focus on your muscles contracting and relaxing. Concentrate on your body exercising, not on thoughts or people around you.
• If the weight's too light (more than 12 repetitions), try using a heavier one with more resistance or do the movement more slowly and really feel the contraction. You should be barely able to finish the tenth rep if your weight is the right one. Of course, as you get stronger with time, increase your weights.
• Keep rest periods to no more than about 20-30 seconds, or shorter, depending on how tired you are from your last set. This will also help to give your heart a mini-workout.

Safety First

Always remember -- safety first! If something you do in an exercise hurts, stop! Ask for help to figure out what you're doing wrong. Maybe it's improper form. If you hurt yourself, you will hinder your progress because you won't want to work out! Learn proper form! Do not exercise if you feel you are coming down with a cold.

Commit Yourself

If you can afford it, join a gym. If you spend the money, you'll be more likely to stay with it, and consistency is the key to success in any exercise program. Also, try to find someone who is enthusiastic to train with, or get a personal trainer (if you can afford one). It's easier to stay motivated when you train with someone else who has a vital interest in your mutual success. It's also safer to have someone to spot you when you lift heavy weight.

Avoid Overtraining

Working out for more than an hour can cause overtraining that can destroy your muscles, decreasing your strength. Overtraining is probably the factor most ignored by exercise enthusiasts. In order to build muscle, the body has to receive a stimulus, a reason, to grow bigger, or hypertrophy. It's really very simple: the body only does what it needs to do, what it is required to do. It isn't going to suddenly expand its muscle mass because it anticipates needing more muscles. But if it is challenged to move weights around, it will respond by growing.

Another way to look at it is, if you take any body builder and put him in bed for weeks at a time, he'll begin to rapidly lose muscle mass because the body will sense that it doesn't need the extra muscle any more. So, one needs to deliver the stimulus to begin muscular hypertrophy (growth) and that's what lifting weights does. However, overdoing exercise stresses out the body and initiates the process of actually breaking down muscle mass as the body begins to burn its own muscles to use for fuel. This is why so many people don't grow at a satisfying rate. Even worse, often times these people will think they aren't training hard enough, and increase their exercise routines, thinking they just need more stimuli! And this is where the biggest error is made -- more is not necessarily better! It seems paradoxical that you could work out less and grow more, but this is very often the case.

Therefore, any exercise beyond that which is the exact amount of stimulus necessary to induce optimal muscle growth is called overtraining.

A Workout Log Is Recommended

The best reason to keep track of your workouts is so you can see graphically what you are accomplishing, and analyze your pattern to see if you're overtraining. You will also be able to see whether you're gaining strength at a reasonable rate. You will find when you log your workouts, that if you are overtraining, you won't be gaining in strength or muscle size. So document your workouts by keeping track of the weight you lift and the amount of reps you lift for each exercise, and then when you go in to train again the next week, you'll know what you are trying to improve upon. If you find out that you're weaker than you were the time before, and everything else like nutrition, etc. is in line, you may be training too often. For downloading workout logs, visit www.exrx.net/WeightTraining/WorkoutLogs.html.

Food and Hydration

Drink at least eight glasses of water a day to keep hydrated. Dehydration can rob you of energy for your workouts. Drink plenty of water while working out and avoid sugary drinks, since they will cause fatigue after an initial burst of energy. Some people like to drink green tea or creatine in juice before a workout to help increase energy levels through a workout.

A light carbohydrate meal (fruits, carbohydrate drinks, etc.) before a workout and a protein-rich one afterwards is advisable. Keep yourself well hydrated with plenty of water throughout the workout. And get plenty of rest aft erwards.

Do not work out after eating a regular meal. Wait at least two hours. If you need a snack, have some fruit and a slice of toast with peanut butter one hour or more before working out. Do not consume protein shakes before working out (leave them for after the workout). Digestion will slow down your workouts and bring your energy down. Within 30-60 minutes after the workout, feed your muscles with a balanced meal containing protein, good fats (olive oil, flaxseed oil), and complex carbohydrates, like fruits and whole grains.

Supplements like glutamine, creatine, and whey protein may be a good thing to consider. A shake containing one heaping tablespoon of glutamine, two tablespoons of flaxseed oil, one or two scoops of whey protein, fruit, and milk (if you are not lactose intolerant, otherwise almond or rice milk, though not soy, since it has been shown to increase estrogen in both men and women), provides a good balanced meal after a workout.

Resources

Two of the best websites for video clips of exercises and an explanation of anatomy are: www.exrx.net/Lists/Directory.html and www.myfit.ca.

Also, several exercise routines are provided on our website, http://medibolics.com/exercise.html.

You can also find most exercise routines explained in videos on youtube.com and menshealth.com.

Be sure to read Michael's and Nelson's book, Built To Survive. For more valuable information, go to powerusa.org.

Nelson Vergel, a native of Venezuela, is a 26-year HIV survivor and advocate for wellness in HIV disease. He is the founding direct or of the Program for Wellness Restoration (PoWeR), the Body Positive Wellness Clinic in Houston, a founding member of the AIDS Treatment Activists Coalition (atac-usa.org), founder/moderator of the largest online HIV health support group (pozhealth at yahoogroups.com), an international speaker, an expert on nutrition and complementary therapies at TheBody.com, and the co-author of the book Built To Survive. Most recently, Nelson was select ed to be a member of the U.S. Department of Health and Human Services HIV Guidelines Panel. For more information about Nelson and his programs, please visit www.powerusa.org.

Michael Mooney is a long-time medical researcher who co-authored "Built To Survive." He was a columnist for Muscle Media for two years, has been interviewed in Sports Illustrated, quoted on ABC's Good Morning America and is Director of Education at SuperNutrition, a best-selling vitamin line. Michael's unique approaches to building bodies will be documented in an exercise video soon. Learn more about Michael's research by visiting his websitewww.michaelmooney.net.

References available online at www.positivelyaware.com.

Got a comment on this article? Write to us at publications@tpan.com.

References

1. Spence DW et al. Arch Phys Med Rehabil. 1990; 71:644-8.
2. Rigsby LW et al. Med Sci Sports Exerc. 1992;24:6-12.
3. Roubenoff R, et al. AIDS. 1999;13:1373-5.
4. Grinspoon S et al. Ann Intern Med. 2000;133:348-55.
5. Strawford A et al. JAMA. 1999;281:1282-90.
6. Yarasheski KE et al. J Appl Physiol. 2001 Jan; 90(1):133-8.
7. Roubenoff et al Appl Physiol. 1999 Apr;86(4):1197-201.
8. Mustafa T et al. Ann Epidemiol. 1999 Feb;9(2):127-31.
9. Rabkin J et al. Med Sci Sports Exerc. 1998 Jun; 30(6):811-7.
10. Tebas P et al. Clinical Infectious Diseases. 2006; 42:108–114
11. Basin S et al. JAMA. 2000;283:763-770.
12. Stringer W et al. Medicine & Science in Sports & Exercise. 30(1):11-16, January 1998.

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The Skinny on Body Fat and HIV

The Skinny on Body Fat and HIV

By Nelson Vergel

Summer 2009

Some people with HIV complain of weight and belly fat gain after they start HIV treatment. But researchers have not been able to determine what causes the problem. Some studies actually dispute that there is a problem, and say that people with HIV do not have more visceral fat than HIV-negative people. But the HIV community as a whole has come to accept the fact that body changes happen to some people living with this virus. The problems associated with increased visceral fat include poor body image, depression, bloating, fatigue, sleep apnea (breathing problems), and possible heart problems. It not only affects the way people look -- it could lower their chances of long-term survival.

Fortunately, the HIV meds most often linked to these problems are no longer commonly used, and newer meds are less likely to lead to changes in body shape and fat metabolism. Data from the several studies, including the Swiss HIV Cohort Study, showed that the use of drugs like Zerit and Retrovir (AZT) declined sharply from 2000 to 2006, along with the number of people who experience body changes.

Lipodystrophy (abnormal fat distribution) has been reported in many HIV studies. It includes one or more of the following: lipoatrophy -- a decrease in the subcutaneous fat directly under the skin (associated mostly with the use of Zerit or AZT); lipohypertrophy -- an increase in the visceral fat deep in the belly; increases in bad (LDL) cholesterol and triglycerides; and decreases in good (HDL) cholesterol, sometimes with an increase in blood sugar. The majority of people taking HIV meds do not experience any body shape changes, but some experience one or more of these metabolic complications. A 2007 meta-analysis of several studies estimated that between 14% and 40% of people taking HIV meds have some form of lipodystrophy.

The Multicenter AIDS Cohort Study (MACS) recently reported that men with HIV in general weigh less than HIV-negative men, but their visceral fat is about the same. Most men with HIV were thinner due to subcutaneous fat loss in the arms, legs, and buttocks, but had as much internal belly fat as the heavier HIV-negative men.

Fortunately, there have been advances in our understanding of lipoatrophy. We now know that it is often linked to the use of Zerit or AZT, and there are two FDA-approved treatments for facial lipoatrophy: Sculptra and Radiesse. However, the same cannot be said about lipohypertrophy, which seems to be caused by many factors. Researchers have not been able to blame any specific drugs. Several studies report that people starting standard HIV combinations have an average increase in visceral fat of 15% after 96 weeks.

An analysis of people in the French APROCO study found that those who started HIV meds with lower CD4 counts gained more visceral fat, possibly due to the large change in their CD4 counts.

It was first thought that protease inhibitors were the main culprits of belly fat gain, but several studies that did not include protease inhibitors also showed increases in visceral fat. An analysis of people in the French APROCO study found that those who started HIV meds with lower CD4 counts gained more visceral fat, possibly due to the large change in their CD4 counts. An analysis of a study comparing Aptivus to Kaletra showed that when taken with Viread and Epivir, the drugs did not increase visceral fat in those who start them with a CD4 count above 250. Some other studies have shown that people who start a protease inhibitor or non-nucleoside along with Zerit, AZT, or Videx seem to have more visceral fat gain than those who start them with other nucleosides. So, the bad guys linked to lipoatrophy may also worsen belly fat.

Switching from a protease inhibitor to Sustiva or Viramune while taking Zerit or AZT has not helped in lowering visceral fat. But a recent small study showed that people who switched from Kaletra to Reyataz while taking Truvada had a decrease of 15% in visceral fat after 6 months. So, we may start to see differences in how HIV meds affect the body when taken with newer nucleoside analogs like Truvada.

Insulin resistance is linked to fat gain, regardless of HIV status. Insulin is a hormone produced by the pancreas, and controls blood glucose (sugar). It captures glucose and pushes it into muscle tissue where it is stored as glycogen for later use as energy. Protease inhibitors may interfere with that process. Also, some people may have a genetic predisposition to insulin resistance. Zerit, AZT, Crixivan, higher doses of Norvir, and most protease inhibitors have been shown in lab studies to impair the action of insulin. This may be a part of the puzzle, but not the entire explanation for visceral fat gain. Aging, poor diet and a lack of exercise may make someone more prone to lipohypertrophy, but people who follow a healthy diet and an exercise program may still suffer from this problem.

What To Do?

Several treatments and approaches have been and are being studied:

Human growth hormone can lower belly fat, but not without side effects. Serostim (a brand of HGH) is approved to treat HIV wasting, but its side effects led the FDA to deny its approval for lipodystrophy. These included joint pain, edema (water retention), increased lipoatrophy and blood sugar increases. Its high cost and lack of insurance reimbursement (due to its lack of FDA approval) are also barriers to use. It requires daily or every other day injections under the skin. But it has been shown to decrease visceral fat by 30% in 6 months.

Tesamorelin is a copy of a hormone that causes the pituitary gland to produce growth hormone. It will soon be up for FDA approval, but, as with Serostim, the FDA may deny approval if no health benefits are seen. Like Serostim, it requires daily injections under the skin but it seems to have milder side effects: mild edema, some joint pain, and a hypersensitivity reaction in 10% of people (sweating and rash). But it does not increase blood sugar or cause lipoatrophy, and it may lower triglycerides, a problem caused by some HIV meds. It has been shown to decrease visceral fat by 15% in 6 months.

Activists are concerned that its price will be high. This could cause insurance companies and Medicare to deny payment since it may be perceived as a cosmetic product. Also, it will be sold in the U.S. by Serono, the same company that sells Serostim. Serono has had poor relations with activists in the past, and was also fined over $700 million by Medicare for using fraudulent practices to induce some physicians to prescribe Serostim.

Leptin is another new contender in the search to decrease visceral fat. This hormone, discovered in 1994, is produced by fat cells. Leptin levels in the blood are generally proportional to the level of body fat. In the hypothalamus (the part of the brain that controls appetite), high levels of leptin suppress the appetite and stimulate fat-burning. Like Serostim, it is taken as an injection under the skin, but it requires two injections a day, though other doses may be studied in the future. In a study of eight men with HIV and lipodystrophy, visceral fat decreased by 32% after 6 months, with no change in subcutaneous fat. Bad (LDL) cholesterol decreased by 16% and good (HDL) cholesterol increased by 19%, with a significant decrease of triglycerides. Leptin was well tolerated but it decreased lean mass. Early, small studies have not shown leptin to have negative effects on blood sugar, as Serostim can. But activists are asking its manufacturer to do larger studies in people with HIV to determine if leptin is useful and if it will be cost-effective.

Metformin is a diabetes drug that at first showed promise in reducing abdominal fat. But later studies have not confirmed this, and have in fact shown that it may worsen lipoatrophy. However, in people without lipoatrophy who have glucose intolerance, metformin may reduce the risk of diabetes and therefore, abdominal fat. Its effects may be enhanced by exercise. Metformin improves insulin sensitivity, triglycerides, and fatty liver, but can cause diarrhea and weight loss (which may itself lead to a decrease in visceral fat). Some people have reported low blood sugar and dizzy spells, so users of this drug should have snacks at hand to increase blood sugar if needed.

Testosterone gels (Androgel, Testim) can reduce waist size in men, but only by lowering subcutaneous fat. In studies, no visceral fat decreases were seen. Testosterone is usually prescribed for people with HIV who have low blood levels of natural testosterone. Data in women are lacking, but one study of 23 women found that those with HIV-related lipodystrophy had higher testosterone levels than HIV-positive women without lipodystrophy. Gels, injections, and a new subcutaneous pellet delivery system are becoming more commonly accepted by physicians.

Oxandrin, an oral anabolic steroid, showed encouraging results for decreasing visceral fat in a small pilot study. But LDL cholesterol increased and HDL cholesterol decreased, along with a small decrease in subcutaneous fat. No body fat studies have been done with the other commonly used anabolic steroid, nandrolone decanoate.

Nutrition studies are lacking. A study at Tufts showed a trend toward less lipodystrophy in those who exercised and increased their soluble fiber (fruits and vegetables). More research is needed on low-carbohydrate diets, which have been shown to improve insulin resistance and visceral fat in HIV-negative people. One observational cohort found that people with HIV eat more saturated fats, which could lead to fat problems. A study of nutrition and lifestyle modifications resulted in decreased belly fat in people with HIV, so there is a clear need for more care providers and organizations to include nutrition and exercise information in their educational efforts.

Sticking to an exercise program can be a challenge for many people who lead busy lives or can't afford to join a gym. But effective home exercise programs are available and could be part of the health counseling given by health care providers and organizations.

Aerobic exercise and weight training decreased triglycerides and visceral fat in a small pilot study. Another study showed that strength training increased lean body mass and decreased fat mass more than aerobic exercise, while improving cholesterol and triglycerides. A regimen of an hour of strength training combined with 20 minutes of aerobic exercise three to four times a week has been shown to work for most people (results take at least eight weeks to be noticeable). But exercise research in HIV remains in its infancy. Sticking to an exercise program can be a challenge for many people who lead busy lives or can't afford to join a gym. But effective home exercise programs are available and could be part of the health counseling given by health care providers and organizations.

Liposuction, assisted by ultrasound, seems to be effective at removing fat from the hump that can occur at the back of the neck. Breaking the fat fibers with ultrasound can loosen them up for easier removal. But this can not be used for removing the visceral fat that surrounds organs in the belly, since removing that is too risky. Some insurance plans and Medicare pay for liposuction when the fat gain is associated with pain or sleep disorders.

Fat gain can also occur in the upper part of the body, especially in the breasts. Some studies show increases in estradiol, a female hormone, in men taking Sustiva. This may cause gynecomastia (increased breast size) in a few people. Drugs like Arimidex, an estrogen blocker, or switching from Sustiva can help those who are in early stages of this problem.

Fat burners are being promoted by some TV commercials. But they have not been shown to work and can increase blood pressure and anxiety. Also, beware of nutritional growth hormone supplements -- there are no data indicating that they work.

Measuring Progress

Current Trials A few studies are currently enrolling in the U.S. to find the best ways to improve cholesterol, triglycerides, and body composition in people with HIV. More info on these studies can be found online by looking for the words in bold under "Choose a treatment" at trialsearch.org. A trial in Houston combines exercise with Niacin (a vitamin that may raise good cholesterol), Tricor (used to lower triglycerides), and prepared meals to look for improvements in lipids and visceral fat. A Boston trial is studyingAvandia plus leptin. Another in St. Louis will look at Actos with exercise for improving insulin resistance, heart metabolism, and heart function. One in Dallas will compare four approaches: a high carbohydrate vs. a high cis-monounsaturated fatty acid diet aerobic exercise with dietary advice omega-3 fish oil capsules leptin The interventions are aimed at improving elevated lipids, insulin resistance, and diabetes. A Los Angeles trial is studying whether switching women from a protease inhibitor or a non-nucleoside like Sustiva to Isentress will reduce body fat in six months. Another at ACRIA and other sites in New York City is looking at Serostim (human growth hormone) with or without Avandia to study the effects on visceral fat. Finally, a study in Los Angeles is combining L-carnitine, a nutritional supplement, with exercise to see if it improves muscle function.

We know when our bodies are changing by the way our clothes fit. Some people go one step further and measure their body dimensions before starting any new program or treatment.

The full-body DEXA scan is the gold standard test in lipodystrophy research, but is hardly used in clinical practice and cannot differentiate between visceral and subcutaneous fat. It's very useful since it gives information about fat, muscle mass, and bone density in every part of the body. It's not expensive (around $130) and is usually covered by Medicare and insurance. It should measure the full body and not just the hip area. Low bone density has also been linked to HIV, so this scan can be useful in detecting early bone changes before fractures happen, but this may not be covered by some insurance plans. A DEXA scan could be considered when someone first tests HIV-positive and then every few years to assess body changes and justify reimbursement for needed treatments. However, there are currently no guidelines for its use in the care of people with HIV.

The best way to assess visceral fat loss is the use of CT scans of the area around the belly button (at the level of vertebrae L4-L5). However, this method is used mostly in research since most insurance companies will not pay for it.

Between 30% and 50% of people with visceral fat may have impaired glucose tolerance (their bodies do not use sugars for energy very well) and may be pre-diabetic. A glucose tolerance test can reveal that problem. Glucose intolerance has been linked to fat gain, increased triglycerides, and development of diabetes. An improvement in glucose tolerance usually leads to fat loss and better lipids.

Conclusion

There is still much to be learned about visceral fat gains and HIV. The first FDA-approved treatment may be available soon, but may come with the barriers of high cost and limited access. There remains a great need for more nutrition and exercise counseling, building on studies of non-pharmaceutical options that cost little to nothing. As people with HIV grow older, advocacy is needed to push for studies of the effect of HIV and its treatment on the body, and to urge insurance companies to reimburse all treatment approaches. Lipodystrophy is a clinical problem that affects quality of life and possibly long-term survival, and it should not be regarded as purely a cosmetic concern.

Nelson Vergel is a treatment activist and the Director of Program For Wellness Restoration: powerusa.org.

Want to read more articles in the Summer 2009 issue of Achieve? Click here.

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