Tenofovir alafenamide fumarate: Phase II data

A double-blind, U.S. Phase II trial in 170 treatment-naïve patients with HIV-1 infection showed that once-daily TAF/elvitegravir/cobicistat/emtricitabine met the primary endpoint of non-inferiority to Gilead's Stribild elvitegravir/cobicistat/emtricitabine/tenofovir in the proportion of patients with HIV RNA levels <50 copies/mL at week 24 (87% vs. 90%). The TAF-based regimen also produced significantly smaller reductions from baseline to week 24 in BMD at the lumbar spine and hip vs. Stribild (p<0.005). Additionally, the TAF-based regimen led to small, significant improvements in serum creatinine and in calculated creatinine clearance vs. Stribild (p<0.02). No patients discontinued treatment for renal adverse events. The trial will be unblinded after week 48, at which point patients will have the option to receive the TAF-based regimen in an open-label rollover extension.

Gilead expects to report 24-week data in 1H13 from a separate Phase II trial comparing a single-tablet regimen of TAF/darunavir/cobicistat/emtricitabine vs. cobicistat-boosted Prezista darunavir plus Truvada emtricitabine/tenofovir in treatment-naïve patients with HIV-1 infection. In 2011, Gilead and the Janssen R&D Ireland unit of Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) partnered to develop the single-tablet therapy containing Prezista (see BioCentury, Nov. 21, 2011). ...