Fosamprenavir Offers Results Similar to Those of Other Protease Inhibitors When Patients With HIV Switch Regimens: Presented at AIDS 2008

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Title: Fosamprenavir Offers Results Similar to Those of Other Protease Inhibitors When Patients With HIV Switch Regimens: Presented at AIDS 2008
URL: http://www.pslgroup.com/dg/2278BA.htm
Doctor's Guide
August 8, 2008

By Kate Jongbloed

MEXICO CITY -- August 8, 2008 -- Patients with human immunodeficiency virus (HIV) who switch from one protease-inhibitor regimen to fosamprenavir demonstrate similar success in maintaining viral suppression, researchers noted here at the 17th International AIDS Conference (AIDS 2008).

"Subjects who were switched to fosamprenavir from another protease-inhibitor regimen [experienced] favourable virologic and safety outcomes," stated Benjamin Young, MD, University of Colorado, Denver, Colorado.

"We compared safety, tolerability, and efficacy of switching subjects who were virologically stable on their current therapy of protease inhibitor to a fosamprenavir-based therapy versus those who maintained their baseline protease-inhibitor therapy," Dr. Young explained, speaking here at a poster presentation on August 5.

Dr. Young and colleagues recruited 304 patients between the ages of 21 and 71 to participate in the open-label, randomised trial. Prior to the study, participants were using protease-inhibitor drugs including atazanavir, indinavir, saquinavir, lopinavir/ritonavir, nelfinavir, and ritonavir.

At the start of the trial, 153 participants were introduced to fosamprenavir while 97 remained on their primary protease-inhibitor regimens. At 24 weeks, this second group was able to switch to fosamprenavir as well, although 43 subjects chose not to switch.

Study results after 48 weeks indicated that subjects who had switched to fosamprenavir either immediately or after 24 weeks increased their CD4-positive cell counts. Those that did not receive fosamprenavir did not experience as much change in their CD4-positive cell counts as those who had switched. Participants who began receiving fosamprenavir at 24 weeks, however, experienced higher virologic response rates by week 48 than did other participants, Dr. Young noted.

Researchers indicated a 15% withdrawal rate for all protease inhibitors, caused by adverse events, lack of efficacy, or other reasons (such as protocol violation or pregnancy). The 3 most common adverse events among the fosamprenavir patients included diarrhoea, increased blood triglycerides, and increased blood bilirubin.

Virologic failure -- meaning viral load of greater than 400 copies/mL -- occurred in 19 subjects from the groups that did not switch to fosamprenavir or that switched at the beginning of the trial. Of these 19 subjects, 8 individuals opted to stay in the trial and had reached a viral load less than 400 copies/mL at the last study visit.

Funding for this study was provided by GlaxoSmithKline, Research Triangle Park, North Carolina.

[Presentation title: Switching to Fosamprenavir (FPV) Led to Similar Efficacy and Safety in HIV-1-Infected Subjects on Their First PI Regimen: A Prospective, Open-Label, Multicenter, Randomized Trial (ESS100290). Abstract TUPE0067]

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