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AIDS wasting, which is known as cachexia, is associated with advanced HIV. Typically, it involves the loss of weight, especially lean muscle mass, which may be replaced by fat. There are a number of factors that cause the weight loss including nausea, loss of appetite, diarrhea, oral issues that result in difficulty eating, and poor nutrient absorption. This condition occurred much more frequently prior to the introduction of antiretroviral therapies that are now used.
Human Growth Hormone can play an important role in cachexia; however, it is important that first a diagnosis be made by the individual’s physician, as there are many other medical conditions that can resemble cachexia.
Once a diagnosis is confirmed, early intervention can have positive results. Proper nutrition, exercise, and appetite stimulants are all inexpensive and commonly used. However, some physicians are now using hGH to treat AIDS wasting and in individuals where there is a natural deficiency of hGH, it is showing positive results.
Currently the hGH regimen for cachexia is a daily injection given at bedtime designed to mimic the natural cycle of growth hormone being released into the bloodstream. The dosages are based on body weight and generally ranges from 4-6 mg. Human Growth Hormone on its own generally leads to weight gain. However, unless combined with resistance exercise to help build lean muscle mass, the gain will be primarily fat.
HGH therapy for cachexia costs on average about $250 per day. AIDS activists placed a great deal of pressure on Serono Labs, which produces Serostim, a version of hGH. As a result, for those individuals that qualified, Serono capped the cost at $36,000 per calendar year. After that, the drug is provided for free.
Lipodystrophy is a term used to describe irregular body fat and metabolic abnormalities that are associated with HIV. It can include increased fat around the abdomen and/or upper back, and the wasting of fat from the arms, legs, face, and buttocks. These metabolic abnormalities include insulin resistance, and increased blood lipid levels.
Some lipodystrophy manifestation is associated with the actually HIV infection, while others are related to the anti-HIV drugs, and still others are tied to the aging process. It becomes even murkier in that body chemistry, lifestyle choices, and genetic factors also play a role.
According to Dr. Graeme Moyle from the London Chelsea and Westminster Hospital, until now much of the treatment of lipodystrophy has been driven by what’s fashionable to do. It’s been more about marketing and less about science.
However, now researchers are collecting scientific data investigating the role of hGH in relieving some of the symptoms associated with lipodystrophy. What they are seeing in a reversal of the increase in abdominal fat. For example, some medications in individuals with wasting can promote fat gain and hGH can reverse that.
St. Luke’s-Roosevelt Hospital in New York City and Donald Kotler, M.D., who is the principal investigator in one of the most complex hGH and lipodystrophy studies to date. The trial called STARS — Serostim in the Treatment of Adipose Redistribution Syndrome. Dr. Kotler presented the study’s most recent results at the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in late September in San Diego.
The multi-center STARS trial randomized 239 HIV positive subjects consisting of 87% male, 13% female; and 80% Caucasion, 20% non-Caucasian, who had an abnormal waist circumference or waist-to-hip ratio. They were to take:
- 4 mg hGH daily
- 4 mg hGH every other day
- or placebo for 12 weeks
A second 12-week phase was then entered by participants during which
- Those who had received daily hGH were randomized to receive placebo (27 subjects) or hGH on alternate days (23 subjects)
- Those who began taking hGH on alternate days continued to do so (48 subjects)
- And the initial placebo group went on to take 4 mg hGH daily (53 subjects).
At some point during the 24-week trial, everyone received hGH at some point during the 24-week trial, but no one received hGH on a daily basis for more than half the trial.
The trial’s principle measurements:
- Reduction of visceral adipose tissue (VAT) this is the firm internal abdominal fat that lies beneath the soft fat just under the skin.
- Levels of non-HDL cholesterol
- Insulin resistance
- Lean body mass
- Self assessed quality of life
- Body image
What Dr. Kotler’s team found was to achieve a significant visceral fat reduction; at the 4 mg dosage a daily dose of hGH was required. Changing to alternating days after the initial daily dosage was adequate to keep the visceral fat from returning. However, when hGH was stopped the fat returned.
Dr. Kotler concluded that VAT reduction, the return of insulin levels to baseline, and the decrease in total and non-HDL cholesterol levels, suggests that hGH therapy could lead to an overall reduction of cardiovascular disease risk to the general population.
Currently hGH is not approved by the FDA in the treatment of lipodystrophy or cachexia. While can prescribe unapproved (off-label) use of hGH, health insurance providers will usually only pay for approved drugs, and unfortunately not many people can afford to buy hGH.
This study is an excellent start in proving that hGH could play an important role in decreasing the body of fat while increasing weight through lean muscle mass.