Gilead announced two-year results from two pivotal Phase 3 studies evaluating the company’s newest single tablet HIV regimen, StribildTM, among treatment-naïve patients with HIV-1 infection. Data show that Stribild was non-inferior after two years of treatment to two standard of care HIV regimens, Atripla in Study 102 and a protease-based regimen of ritonavir-boosted atazanavir plus Truvada in Study 103. The regimen was approved by the FDA on August 27 for use by treatment-naïve HIV-positive adults based on 48-week results from Studies 102 and 103. A marketing application for Stribild is currently under review in the European Union.
- Pharmaceuticals & Drug Trials