New study on Egrifta ( tesamorelin ) compared to Serostim (HGH) in HIV + men.

Appleby discussed the differences between EGRIFTA and Serostim, a synthetic version of Human Growth Hormone that is FDA approved for the treatment of HIV-related wasting and weight loss. In its trials, Serostim also reversed the effects of lipodystrophy, but the FDA was not convinced that the risks associated with Serastim outweighed its benefits with lipodystrophy, and did not approve it for that purpose.

The differences between Serostim and EGRIFTA are significant. Serostim (generic name: somatropin) is a daily injection of a synthetic hormone that often comes with severe side effects including joint and muscle pain, swelling, and an increase in glucose levels in the bloodstream that can increase the risk of diabetes. The desired effects of Serostim begin to be visible after a few weeks on the drug, and the monthly cost is a staggering $10,000. EGRIFTA (generic name: tesamorelin) is a daily injection of a drug that causes the body to produce its own growth hormone. The possible side effects, including fluid retention, pain, rash and glucose intolerance, are mild in comparison to Serostim. The good results begin to be visible in three months, and the monthly cost of treatment is a less staggering $2,900.

EGRIFTA will not reverse facial wasting and will not increase arm or leg width. It does not address the kind of fat that is acquired through overeating and not exercising. It specifically targets fat surrounding the internal organs in the abdomen.

Appleby described the trials that led to the FDA approval of EGRIFTA. No one with an active malignancy was allowed to participate, and all participants had to be off Serostim for at least 6 months. Those in the study were also asked to follow a healthy diet and exercise routine. The critical results were calculated not in weight but in fat distribution measurements. Steve was one of the participants in those trials who experienced a satisfying reduction of his lipohypertrophy, and then its unfortunate return after the treatments ended.

Despite the fact that the FDA has approved EGRIFTA as a treatment for a syndrome that can be damaging to the cardio-vascular system, the biggest marketing hurdle is the refusal of many insurance companies to consider it anything more than a cosmetic treatment. Those insurers are also shortsighted in their refusal to see that erasing the scarlet letter of HIV infection will have a restorative impact on the daily lives of HIV-positive men, with an overall betterment of their health and a consequential lowering of other costly HIV-related treatments and medications covered by most health insurance providers. During the question and answer portion of the EGRIFTA seminar, some spoke about the unclear possibility of a patient assistance program and about current monthly co-pays that vary drastically from a few dollars to a reported high of $600. In the USA, EGRIFTA is distributed by Serono Laboratories and is not currently available at some of the national drug store chains. Many HIV doctors are still unfamiliar with EGRIFTA, and their patients are driving their continued education with requests for the treatment.

After the seminar, Steve reported that the attendees were satisfied that EGRIFTA’s benefits are clear, as was the fact that there is little that can be done but wait for the drug’s developer and marketer to battle successfully with health insurance companies that consider it an unnecessary cosmetic intervention, similar to liposuction.

At the POZitive Attitudes meeting, Appleby was preaching to the choir when he concluded his seminar by saying “The bottom line is that EGRIFTA is a good drug with few side effects.”

Miami HGH dsitributor convicted.

Jeffrey H. Sloman, Acting United States Attorney for the Southern District of Florida, and David W. Bourne, Special Agent in Charge, U.S. Food and Drug Administration ( FDA ), Office of Criminal Investigations, Miami Field Office, announced that after a two week trial before U.S. District Judge Alan S. Gold, a jury convicted Arnesto Segredo, 43, of Miami, of conspiring to divert the prescription drugs Serostim and Nutropin AQ, both human growth hormones, and one count of causing the diversion of these human growth hormones, in interstate commerce. Sentencing is scheduled for October 23, 2009 at 4:00 p.m.

According to the evidence presented at trial, Segredo caused California-based human growth hormone suppliers, all of which were unlicensed to engage in the wholesale distribution of prescription drugs in California, to regularly ship to him in Miami hundreds of boxes of Serostim, and some Nutropin AQ, from 2000 through the end of 2002. Serostim is an injectable drug approved by the FDA for the treatment of AIDS-wasting syndrome in HIV-infected patients, and Nutropin AQ is an injectable drug approved by the FDA for the treatment of growth hormone deficiency, including children with short stature.

From 2000 through 2001, Segredo operated Life Extension Institute, a Miami-based prescription drug wholesaler, which was also not licensed to engage in the distribution of prescription drugs in Florida. He later operated through Genendo Purchasing Organization, a Miami-based prescription drug wholesaler that became licensed in Florida in July 2001. A significant portion of the Serostim that Segredo distributed through these two companies originated from California-based AIDS patients who sold their Serostim supplies secured from the Medi-Cal Medicaid program.