Gilead announced that a Phase 3 study evaluating its investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) for the treatment of HIV-1 infection met its primary objective.

The Phase 3 study is a randomized, double-blind clinical trial among 663 virologically suppressed adults (HIV-1 RNA levels <50 copies/mL) on a stable regimen containing Truvada (FTC/TDF) for ≥6 consecutive months. Patients were randomized 1:1 to either maintain their Truvada-based regimen (Truvada + placebo + third agent) or switch to an F/TAF-based regimen (F/TAF + placebo + third agent). The study will follow patients for 96 weeks after randomization. The primary objective is to evaluate the efficacy of switching FTC/TDF to F/TAF vs. maintaining FTC/TDF as determined by the proportion of subjects with HIV-1 RNA <50 copies/mL at Week 48 as defined by the FDA snapshot analysis.

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The study is ongoing but preliminary results show that 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-1 RNA levels <50 copies/mL (94.3% for F/TAF-based regimens vs. 93% for TDF-based regimens; difference in percentages: 1.3%, 95% CI: -2.5–5.1%). 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).

In April 2015, Gilead filed a New Drug Application (NDA) with the Food and Drug Administration (FDA) for two fixed-dose combinations of F/TAF (200/10mg and 200/25mg), and the FDA has set a target review date of April 7, 2016.

TAF is a novel nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread (TDF), as well as improved renal and bone laboratory parameters compared to TDF in combination with other antiretroviral agents.

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