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October 2, 2008

FDA Approves Boosted-Reyataz for Treatment First-Timers

The U.S. Food and Drug Administration (FDA) has approved Reyataz (atazanavir) boosted with low-dose Norvir (ritonavir) for use in people who are new to antiretroviral (ARV) therapy.

Doctors who prescribe Reyataz for ARV first-timers often recommend that it be boosted with Norvir, based on early evidence suggesting that it was a more effective way to use the protease inhibitor. Similarly, HIV treatment guidelines from the U.S. Department of Health and Human Services (DHHS) have for several years recommended that Reyataz for ARV newcomers be boosted with Norvir.

Official FDA approval was based on Bristol-Myers Squibb’s submission of 48-weeks worth of data from the 96-week CASTLE study, which found that boosted once-daily Reyataz plus Truvada (tenofovir plus emtricitabine) had similar efficacy and safety to twice-daily Kaletra (lopinavir/ritonavir) plus Truvada.

Search: Reyataz, atazanavir, Norvir, ritonavir, Kaletra, lopinavir, Truvada, tenofovir, emtricitabine, FDA


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