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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).