Gilead Sciences, Inc. (Nasdaq: GILD) today announced three-year (144-week) efficacy and safety results from two pivotal Phase 3 studies (Studies 102 and 103) evaluating the once-daily single tablet regimen Stribild
(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 after three years of treatment, Stribild demonstrated comparable efficacy 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 inhibitor-based regimen of ritonavir-boosted atazanavir plus Truvada
(emtricitabine and tenofovir disoproxil fumarate) in Study 103. These data are being presented this week at the 14th European AIDS Clinical Society Conference (EACS) in Brussels, Belgium.
“HIV has become a chronic disease that can be managed with life-long therapy, increasing the need for convenient, once-daily treatment options that offer long-term efficacy and tolerability,” said Jürgen Rockstroh, MD, Professor of Medicine, University of Bonn, Germany. “In these large-scale clinical trials, Stribild demonstrated high and durable viral suppression and a favorable safety profile over three years of therapy. These results support Stribild as an important single-tablet treatment option for people starting antiretroviral therapy.”
Study 102 found that, at 144 weeks of treatment, 80 percent of Stribild patients (n=279/348) compared to 75 percent of patients receiving Atripla (n=265/352) achieved HIV RNA (viral load) less than 50 copies/mL based on the FDA snapshot algorithm (95 percent CI for the difference: -1.3 to 11.1 percent for Stribild vs. Atripla).
Similarly, in Study 103, 78 percent of Stribild patients (n=274/353) versus 75 percent of patients taking a protease inhibitor-based regimen of ritonavir-boosted atazanavir plus Truvada (n=265/355) achieved HIV RNA less than 50 copies/mL (95 percent CI for the difference: -3.2 to 9.4 percent for Stribild vs. the atazanavir-based regimen).
In both studies, rates of discontinuation due to adverse events were similar across all treatment groups (6 percent for Stribild in each study, 8 percent for Atripla and 9 percent for the atazanavir-based regimen).