In the news ... 2008

Prezista granted expanded approval

by Paul Dalton, October 25, 2008

The Food and Drug Administration has granted traditional approval for the protease inhibitor Prezista (darunavir) as well as expanded its approval to include its use as part of a person’s first HIV regimen. The decision follows impressive results from the POWER, ARTEMIS and TITAN studies.

Prezista was given accelerated approval in June 2006 for use by people with experience taking HIV therapy, based on results from POWER 1 and 2. These studies found the drug to be superior to placebo when taken with optimized background therapy. The traditional approval was based in part on 96-week follow-up data from these studies that showed sustained reductions in HIV levels.

The ARTEMIS study of almost 700 people compared once-a-day Prezista to Kaletra, both taken with the fixed dose combination Truvada (tenofovir + emtricitabine/FTC). After 48 weeks, 84% of people taking Prezista had HIV levels below 50 copies, compared to 78% of those on Kaletra. There were similar rates of side effects between the two groups.

TITAN studied almost 600 people with some experience on HIV treatment, who had never taken Kaletra. People took either Prezista or Kaletra together with at least 2 other HIV drugs. After 48 weeks, more people taking Prezista (77% vs. 67%) had HIV levels below 50 copies. Rates of side effects were similar between the groups.

People taking HIV treatment for the first time will take 800mg Prezista (two 400mg capsules) + 100mg Norvir (ritonavir) once daily. The 400mg tablets will be available in pharmacies on November 1, 2008.