The FINANCIAL — Gilead Sciences, Inc. on September 2 announced that a Phase 3 study evaluating its investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 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 percent for F/TAF-based regimens versus 93.0 percent for TDF-based regimens; difference in percentages: 1.3 percent, 95 percent CI: -2.5 percent to 5.1 percent), according to Gilead.
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). General safety and discontinuation rates due to adverse events were comparable between the two arms. The most commonly reported adverse events included upper respiratory tract infection, diarrhea, nasopharyngitis, headache and bronchitis. Both regimens were generally well tolerated. Gilead plans to submit these data for presentation at a scientific conference in 2016.
“For more than a decade, Truvada has been a cornerstone of HIV therapy, and the results of this and other recent trials demonstrate the potential of F/TAF to become a next-generation backbone,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “The results from this study reinforce the efficacy, as well as the renal and bone safety advantages of TAF for patients who face a lifetime of treatment.”
In April 2015, Gilead filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for two fixed-dose combinations of F/TAF (200/10 mg and 200/25 mg), and the FDA has set a target review date under the Prescription Drug User Fee Act of April 7, 2016. A Marketing Authorization Application (MAA) in the European Union for F/TAF was fully validated on May 28, 2015.
TAF and TAF-based regimens are investigational products and have not been determined to be safe or efficacious.
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