HGH Approved by FDA for Treating AIDS Wasting

AIDS wasting is called cachexia. Typically there is weight loss, specifically lean muscle mass, which is sometimes replaced with fat. There are other symptoms including loss of appetite, nausea, diarrhea, poor nutrient absorption, and oral issues that make it difficult to eat.

FDA Approves HGH to Treat AIDS Wasting

HIVThe Food and Drug Administration has approved a treatment allowing Serono Laboratories to distribute its experimental version of HGH (human growth hormone) to individuals who are suffering with AIDS-related wasting syndrome. In order for a person with AIDS to receive HGH, they must have lost 10% of their normal body weight without any apparent cause, and they must have tried the appetite stimulants Marinol and Megace.

HGH rehabilitates the body’s metabolism so that is focuses on rebuilding the protein stores that have been lost from lean tissue mass as a result of AIDS. Wasting can be acute, caused by a definite gastrointestinal infection or other type of infection; or it can be chronic and non- specific.

The treatment IND covers 12 weeks of therapy during which time doctors must examine their patients 4 times and collect basic safety data for Serono. Patients can be re-enrolled for an another 12 weeks if they still need HGH after the first 12 week period.

Patients or a third- party will be responsible for the reimbursement of doctors for collecting data and costs associated with the paper, and patients will pay $25 per mg of HGH, and a daily dose is 6 mg. This cost recovery is a precedent-setting aspect of Serono’s treatment IND. That’s a cost of $150 per day.

AIDS activists put a lot of pressure on Serono Labs, the pharmaceutical company that produces Serostim (HGH). Because of this pressure if a person qualifies, Serono has put a cap of $36,000 per calendar year. After that, the drug will be provided free.

The Role of HGH in Cachexia

While there is no question that HGH plays an important role in AIDS wasting or cachexia, it is critical that the patient’s doctor make a diagnosis and first rule out any other medical conditions that are similar to cachexia.

Once the doctor has confirmed cachexia, Good nutrition, appetite stimulates, and exercise are all tried first. They are are affordable and for some they work. However, for others they do not and so many doctors are turning to HGH as a treatment for AIDS wasting. It is much better now that the FDA has approved HGH for the use in AID wasting or cachexia, because the results have been very positive.

Treating With HGH

Currently the HGH regimen is a daily injection at bedtime. This best mimics the body’s natural cycle for producing HGH and releasing it into the bloodstream. Dosages are related to body weight. It is important that exercise is combined with HGH otherwise the weight gain will be unhealthy fat called lipodystrophy.

This term also describes metabolic abnormalities that are associated with HIV/AIDS. This included the wasting of fat in the face, buttocks, arms and legs, increased fat in the upper back and abdomen areas, increased blood lipids, and insulin resistance. Some manifestations of lipodystrophy are the result of the HIV drugs while others are caused by the actual HIV infection.

Researchers have been gathering scientific data to study the role HGH has in relieving some of the lipodystrophy symptoms. What they consistently finding is that there is a reversal of the increase in abdominal fat.

The STARS Study

St. Luke’s-Roosevelt Hospital in New York City and the main investigator Donald Kotler, M.D., conducted one of the most complex HGH and lipodystrophy studies, called STARS — Serostim in the Treatment of Adipose Redistribution Syndrome. The study’s most recent results were presented by Dr. Kotler at the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) that was held in San Diego in late September.

The multi-center STARS trial randomized 239 HIV positive subjects

  • 87% male
  • 13% female
  • 80% Caucasion
  • 20% non-Caucasian
  • All 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 measured:

  • Levels of non-HDL cholesterol
  • Reduction of visceral adipose tissue (VAT).
  • Insulin resistance
  • Self assessed quality of life
  • Lean body mass
  • Body image

Conclusion

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. After the initial daily dosage, going to alternating days was sufficient to keep the visceral fat from returning. However, when hGH was stopped the fat returned.

Er. Kotler concluded that the return of insulin levels to baseline, VAT reduction, and the decrease in total and non-HDL cholesterol levels, indicates that HGH therapy could lead to an overall reduction of cardiovascular disease risk to the general population.

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.

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