There is currently no effective drug treatment available for the treatmen of excess abdominal fat caused by lipodystrophy – but that could change very soon.
A US Food and Drug Administration (FDAThe U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the nation's blood supply. The Australian equivalent is the Therapeutic Goods Administration (TGA).) advisory committee has unanimously recommended that tesamorelin (Egrifta), an experimental(Of a drug) Not licensed for use in humans, or as a treatment for a particular condition. Experimental drugs are studied in clinical trials to determine their safety and efficacy, and are sometimes made available via Special Access Schemes prior to their approval. product be approved by the agency. Though the FDA is not required to follow the recommendations of its advisory committees, it usually does so.
Egrifta is an injectable synthetic human growth hormone-releasing factor. Phase IIIA large clinical trial designed to establish whether a drug is effective and safe enough for widespread use. Phase III studies include expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. clinical trials of the drug indicate that it decreases visceral adipose tissue (VAT) – fat deep within the belly – by about 17%.
There are, however, conflicting reports regarding the risk of diabetes[Diabetes mellitus] A disorder in which sugars in the diet cannot be metabolised into energy due to a lack of the enzyme insulin. Late-onset diabetes mellitus may be a long-term side effect of some anti-HIV drugs. in people receiving the treatment in these trials.
Theratechnologies, who manufacture Egrifta, is already planning a safety monitoring program that will go into effect if the FDA agrees with the advisory committee panel and approves the drug for use in the United States.