Gilead's fixed-dose combo F/TAF meets Phase III endpoint

US biotech giant Gilead Sciences (Nasdaq: GILD) says that a Phase III study evaluating its investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10mg and 200/2 mg) (F/TAF) for the treatment of HIV-1 infection met its primary objective.

The ongoing study was designed to explore the efficacy and safety of F/TAF-based regimens among virologically suppressed adult patients switching from HIV treatment regimens containing emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (Truvada). At Week 48, the F/TAF-based regimens and the TDF-based regimens achieved similar rates of virologic suppression based on the proportion of patients with HIV RNA levels (viral load) of less than 50 copies/mL (94.3% for F/TAF-based regimens versus 93.0% for TDF-based regimens; difference in percentages: 1.3%, 95%CI: -2.5% to 5.1%.

Compared to the TDF-based regimens, the F/TAF-based regimens demonstrated statistically-significant differences in mean bone mineral density (BMD) at the hip and spine (p<0.001) and in the median change in estimated glomerular filtration rate (eGFR) (p<0.001).