New HIV Combination Medication Meets Primary Objective
The FDA has set a target review date of April 7, 2016.
Officials with 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 study is ongoing but preliminary Gilead officials report 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 with the Food and Drug Administration 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.