NDA for New HIV-1 Single Tablet Combination Therapy
Bristol-Myers Squibb and Gilead announced that it has submitted to the FDA a New Drug Application (NDA) for a fixed-dose combination of atazanavir sulfate, a protease inhibitor and cobicistat (Gilead), an investigational pharmacokinetic enhancer or boosting agent for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Currently, atazanavir is the only protease inhibitor being evaluated with cobicistat in a prospective, randomized Phase 3 double-blind clinical trial (Gilead Study 114). The study is comparing the efficacy and safety of cobicistat-boosed Reyataz vs. ritonavir-boosted Reyataz in treatment-naïve adult patients for 48 weeks. Study 114 may support the clinical use of atazanavir and cobicistat together.
Reyataz (atazanavir sulfate) is already approved for the treatment of HIV-1, in combination with other antiretroviral agents, in patients ages 6 and older who are treatment-naïve or treatment-experienced.