New HIV Combo Drug Comparable to Standard Tx in Phase 3 Study

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.

For more information call (800) 445–3235 or visit Gilead.com.

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