- A Phase 3 clinical trial assessing the safety and efficacy of Gilead Sciences' (GILD +1.2%) investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) (200/10 mg and 200/25 mg) in HIV-1 patients switching from Truvada (emtricitabine/tenofovir disoproxil fumarate) (FTC/TDF) met its primary endpoint. At week 48, both regimens achieved similar rates of virologic suppression as measured by the proportion of patients with HIV RNA levels (viral load) of <50 copies/mL, 94.3% for F/TAF and 93.0% for FTC/TDF.
- Secondary endpoints assessed renal and bone safety as measured by by estimated glomerular filtration rate (eGFR) and hip and spine bone mineral density (BMD) at week 48 (and again at week 96). The F/TAF regimen showed statistically significant differences in favor of F/TAF in the two parameters compared to Truvada. The study is ongoing. Its estimated completion date is July 2016.
- TAF delivers comparable antiviral efficacy to TDF at less than one-tenth the dose while being much less stressful on the kidneys and bones.
- The company filed an NDA with the FDA in April for the two fixed-dose combinations of F/TAF. The PDUFA date is April 7, 2016. Its MAA in the EU was validated on May 28.