FDA Approves Two New HIV Combo Pills

The U.S. Food and Drug Administration has approved two once-daily, fixed-dose combination pills for HIV that use previously approved single drugs: Prezcobix and Evotaz. Janssen’s Prezcobix is a combination of the protease inhibitor darunavir and boosting agent cobicistat. It’s useful for patients new to treatment and those who haven’t developed a resistance to darunavir, which is marketed under the brand name Prezista as an individual antiretroviral. Cobicistat (brand name Tybost) raises the level of other antiretroviral drugs.

“This approval gives physicians the option of a darunavir-based fixed-dose combination tablet to treat adults living with the HIV-1 infection, which can help reduce the number of pills in their overall treatment regimen,” said Karen Tashima, a professor of medicine in the division of infectious diseases at Brown University and a lead investigator in the study that led to Prezcobix’s approval. “Additional options remain an important medical priority to meet the diverse needs of those living with and managing this disease.”

Bristol-Myers Squibb’s Evotaz combines cobicistat and the protease inhibitor atazanavir (brand name Reyataz). BMS officials said Evotaz performed well in a 602-patient clinical trial compared with ritonavir-boosted atazanavir, with sustained effectiveness and safety through 48 weeks. Some 85 percent of those taking the cobicistat combination and 87 percent of those on the ritonavir regimen achieved HIV levels of below 50 copies per milliliter of blood.