Gilead Sciences (Nasdaq:GILD) today announced two-year (96-week) results from two pivotal Phase 3 studies (Studies 102 and 103) evaluating the company’s newest single tablet HIV regimen, Stribild TM (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), 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 ® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Study 102 and a protease-based regimen of ritonavir-boosted atazanavir plus Truvada ® (emtricitabine and tenofovir disoproxil fumarate) in Study 103. These results were presented today in an oral session at the 11th International Congress on Drug Therapy in HIV Infection (HIV11) in Glasgow, United Kingdom.
“In these studies, Stribild demonstrated a robust clinical profile, including sustained efficacy, safety and resistance results over two years of treatment,” said Jürgen Rockstroh, MD, Professor of Medicine, University of Bonn, Germany and a lead investigator for Study 103. “Stribild was also associated with a lower incidence of certain central nervous system side effects compared to Atripla, and had a favorable triglycerides profile versus the atazanavir-based regimen.”
Stribild combines four compounds in one daily tablet: elvitegravir, an integrase inhibitor; cobicistat, a pharmacoenhancing agent; emtricitabine and tenofovir disoproxil fumarate. The regimen was approved by the U.S. Food and Drug Administration (FDA) on August 27, 2012 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.
Study 102 found that at 96 weeks of treatment, 84 percent of Stribild patients (n=293/348) and 82 percent of Atripla patients (n=287/352) achieved HIV RNA (viral load) < 50 copies/mL, based on the FDA snapshot algorithm (95 percent CI for the difference: -2.9 to +8.3 percent for Stribild vs. Atripla; predefined criterion for non-inferiority was a lower bound of a two sided 95 percent CI of -12 percent).