Gilead Sciences reports positive trial results for combination HIV therapy

Gilead Sciences has announced the findings of four clinical trials that highlight the safety and efficacy of a new combination therapy for HIV-1.

The four phase III studies evaluated a fixed-dose combination of bictegravir, a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (FTC/TAF) for the treatment of HIV-1 infection.

All of the trials met their primary objectives of non-inferiority, with three of the ongoing studies comparing the new combination to regimens containing dolutegravir, while the fourth compared switching to the new treatment to remaining on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor.

Gilead designed the new regimen to combine the potency of the integrase inhibitor bictegravir with the demonstrated efficacy and safety profile of the FTC/TAF backbone.

The company plans to submit regulatory applications for this new treatment approach in the US and Europe later this year, with data from these studies to support this process.

Dr Norbert Bischofberger, executive vice-president for research and development and chief scientific officer at Gilead Sciences, said: "Based on the results from these phase III studies, the combination of bictegravir and FTC/TAF could represent an important advance in triple-therapy treatment for a broad range of HIV patients."

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