Data shows FUZEON does not increase lipodystrophy in pre-treated HIV patients


Lower incidence of diarrhoea reported with FUZEON

Basel, 12 February, 2004 - A new 48-week analysis of the TORO 1 and 2 studies indicates that FUZEON (enfuvirtide) has no adverse impact on lipid profiles or body fat distribution (lipodystrophy and lipoatrophy). In addition, patients on FUZEON reported approximately half the incidence of diarrhoea. These findings support the pivotal role of FUZEON in HAART.

"Toxicities, and in particular lipodystrophy and lipoatrophy, are a real challenge for HIV treating physicians and patients and drug toxicities are the main reason why patients discontinue therapy" commented Professor David Cooper, Director, Australian National Centre for HIV Epidemiology and Clinical Research (NCHECR) St Vincent's Hospital, Sydney. "With FUZEON, we are now able to look into establishing a new standard of care for pre-treated patients and in Australia we are investigating other approaches to spare or reduce toxicity using FUZEON. First results from our toxicity sparing trial using FUZEON are expected to be presented later this year."

What is lipodystrophy/lipoatrophy?
Body fat changes in HIV are known as lipodystrophy and lipoatrophy. There are three general patterns of body fat changes that are seen in people with HIV who are taking combination anti-retroviral (ARV) therapy; gaining fat on the abdomen, between the shoulder blades or around the neck or in the breasts (lipodystrophy); losing fat from under the skin which becomes obvious in the face, arms, legs and buttocks (lipoatrophy); and a mixture of both fat gain and fat loss. These fat changes are often known as "fat redistribution" and can be accompanied by metabolic changes (rises in levels of fats and sugar in the blood).

Latest FUZEON data
This new analysis included DEXA (dual x-ray absorptiometry) body composition scans in a sub-group of patients in the TORO studies, which showed that those in the FUZEON arm (n =65) experienced little to no median changes from baseline in fat redistribution at 48 weeks, compared to patients taking a regimen that did not include FUZEON (n=12). There were no relevant differences between the two arms in the magnitude of changes for glucose, total cholesterol, LDL cholesterol and triglycerides. Previously presented safety analysis at 48 weeks showed that adding FUZEON to the treatment regimen did not exacerbate most of the known toxicities associated with other ARV's. In particular, the reported incidence of diarrhea in the FUZEON containing arm was approximately half that of the arm without FUZEON. There were no differences between the two arms in the magnitude of changes for glucose, total cholesterol, LDL cholesterol and triglycerides. Small differences were observed for insulin and very low-density levels.

With the introduction of FUZEON, physicians now have available four classes of anti-retroviral therapy and an important new option for pre-treated patients. The antiretroviral drug classes available prior to the introduction of FUZEON (the reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and the protease inhibitors) work inside the already infected CD4 cell. However, FUZEON works before the other classes of drugs, acting outside the immune cell and blocking the virus before it can enter. Based on the results presented at CROI, Roche is exploring clinical research to assess the benefits of adding FUZEON to nucleoside sparing regimens designed to decrease toxicities associated with HIV treatment. This approach is being supported by the NCHECR, the Australian research centre that pioneered research into risks of body fat distribution linked to lipodystrophy.

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Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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