Gilead Sciences reports positive trial data for new combination HIV therapy

Gilead Sciences has announced positive clinical trial data from a phase III study evaluating its investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) for the treatment of HIV-1 infections.

The 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, also known as Truvada.

After 48 weeks, it was shown that the F/TAF-based regimens and Truvada achieved similar rates of virologic suppression, as well as improved performance in terms of bone mineral density and estimated glomerular filtration rate.

Having achieved its primary efficacy endpoint in this trial, Gilead will be using the data to support regulatory assessments for the drug that are ongoing in the US and Europe.

Dr Norbert Bischofberger, executive vice-president for research and development and chief scientific officer at Gilead Sciences, said: "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."

The investigational fixed-dose F/TAF combination therapy for HIV was also accepted for EU review earlier this year. An alternative treatment combining emtricitabine, tenofovir alafenamide and rilpivirine is also being examined.