Nov 1 2012
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that a Phase 2 clinical trial evaluating tenofovir alafenamide fumarate (TAF; formerly referred to as GS-7340), an investigational novel prodrug of tenofovir for the treatment of HIV-1 infection, met its primary objective. The ongoing study compares a once-daily single tablet regimen containing TAF 10 mg/elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg with StribildTM (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) among treatment-naïve adults. The TAF-based regimen achieved a similar virologic response to Stribild based on the proportion of patients with HIV RNA levels (viral load) of less than 50 copies/mL at 24 weeks of therapy (87 percent versus 90 percent, respectively).
Compared to Stribild, the TAF-based regimen demonstrated statistically significantly smaller reductions from baseline to week 24 in bone mineral density at the lumbar spine and hip (p<0.005). In addition, small, statistically significant differences were seen in serum creatinine and in calculated creatinine clearance between the two arms in favor of the TAF-containing regimen (p<0.02). No patient discontinued study drug for renal adverse events. There were no statistically significant differences in the frequency of laboratory abnormalities and the frequency and nature of adverse events were generally similar between the two arms. Both regimens were generally well tolerated. Gilead plans to submit these data for presentation at a scientific conference next year.
"These interim findings are encouraging and warrant advancing this TAF-containing single tablet regimen into Phase 3 development," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences.
TAF is also being studied in a second ongoing Phase 2 trial evaluating a single tablet regimen containing TAF, Janssen R&D Ireland's protease inhibitor Prezista® (darunavir), cobicistat and emtricitabine compared to Truvada® (emtricitabine and tenofovir disoproxil fumarate) plus Prezista and cobicistat, dosed as individual components. The study is fully enrolled and 24-week results will be available in the first half of 2013.