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news.Gilead Sciences has reported that Phase 2 trial of tenofovir alafenamide fumarate (TAF), designed to treat HIV, has met its 24-week primary objective.
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The ongoing double-blind 48-week trial is evaluating TAF 10mg/elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg with Stribild in treatment-naïve adults.
A comparable virologic response was observed at 24 weeks of therapy in TAF-based regimen and Stribild based on patient group with HIV RNA levels of less than 50 copies/mL.
Statistically appreciably smaller reductions in bone mineral density at the lumbar spine and hip, from baseline to week 24, were noted in TAF-based regimen as compared to Stribild.
Gilead Sciences chief scientific officer, research and development executive vice president Norbert Bischofberger said, "These interim findings are encouraging and warrant advancing this TAF-containing single tablet regimen into Phase 3 development."
Additionally, the study reported small, statistically significant differences in serum creatinine and in calculated creatinine clearance between the arms, favoring TAF-based regimen.
No considerable differences in the occurrence of laboratory abnormalities and adverse events were observed in the two arms.