Gilead’s Stribild Posts Three-Year HIV-1 Results

Gilead Sciences has posted three-year (144-week) efficacy and safety results from two pivotal Phase III studies (Studies 102 and 103) evaluating the once-daily single tablet regimen combination drug 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) and a protease inhibitor-based regimen of ritonavir-boosted atazanavir plus Truvada (emtricitabine and tenofovir disoproxil fumarate).

One study showed that 80% of Stribild patients achieved HIV RNA (viral load) less than 50 copies/mL based on the FDA snapshot algorithm, compared to 75 percent of patients receiving Atripla, after three years. The other study showed 78 percent of Stribild patients versus 75 percent of patients taking a protease inhibitor-based regimen of ritonavir-boosted atazanavir plus Truvada achieved HIV RNA less than 50 copies/mL.

Stribild was approved by the FDA in August 2012 and by the EC in May 2013.