October 08, 2009
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FDA advisory committee recommends maraviroc for treatment-naive patients with HIV

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The FDA Antiviral Drugs Advisory Committee has voted to recommend maraviroc (Selzentry, Pfizer) tablets for use in treatment-naive adult patients with CCR5-tropic HIV.

The decision came in the wake of 48- and 96-week efficacy and safety data from the ongoing phase III MERIT trial and the MERIT ES trial.

Results of these trials demonstrated that, at 48 weeks, maraviroc plus zidovudine/lamivudine (Combivir, GlaxoSmithKline) was as effective as efavirenz (Sustiva, Bristol Myers Squibb) plus zidovudine/lamivudine in reducing viral load to the co-primary endpoint of <400 copies/mL. However, the maraviroc combination did not achieve non-inferiority in reaching the other co-primary endpoint, which was to reduce the viral load to <50 copies/mL at 48 weeks.

Among patients who remained on therapy until the 96-week mark, safety results indicated less than half the number of malignancies were observed in patients taking the maraviroc regimen than in those taking the efavirenz regimen. There were no new safety signals identified with maraviroc treatment at 96 weeks.

Maraviroc was previously given accelerated approval in August 2007 and full approval in November 2008 by the FDA for use in treatment-experienced adult patients with only CCR5-tropic HIV-1 virus in combination with other antiretroviral therapies.