By Advocate.com Editors
Originally published on Advocate.com November 20 2002 12:00 AM ET
Officials from pharmaceutical company Roche, which codeveloped Fuzeon, the first HIV entry inhibitor currently under review at the Food and Drug Administration, said Monday at a meeting in Scotland that the medication is most effective when used by HIV-positive people for whom at least two other anti-HIV drugs are still working, the Raleigh News and Observer reports. The remarks were part of a presentation of a 24-week study of the injectable anti-HIV drug. All of the treatment-experienced HIV-positive study participants benefited from adding Fuzeon to their treatment regimens, including those on failing combinations, but the biggest reductions in HIV viral loads were experienced by those who had at least two other anti-HIV drugs in their regimens to which they had not developed resistance.
The majority of the study participants also reported that the twice-daily injections of Fuzeon were "manageable" and did not cause substantial changes in their daily routines. "The combination of better than expected efficacy, tolerability, and adherence data with the increasing incidence of drug resistance means demand for Fuzeon will be greater than initially anticipated," said David Reddy, head of HIV/AIDS drugs at Roche. The FDA is expected to grant marketing approval for Fuzeon in the first quarter of 2003. The medication will likely cost between $12,000 and $15,000 per patient per year, making it the most expensive anti-HIV medication on the market, analysts say.