New Drug Application Submitted for Triple-Therapy HIV Drug

Gilead recently submitted a new drug application for the approval of a novel, once-daily HIV combination therapy. The investigational fixed-dose drug contains bictegravir 50-mg, an integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide 200/25-mg, called BIC/FTC/TAC, according to a press release.

The experimental combination therapy has shown high rates of virologic suppression among patients with HIV-1. Additionally, there were no treatment-related resistance developed through 48 weeks in a phase 3 clinical trial, which included treatment-naïve patients and virologically suppressed patients who switched treatments.

The drug application is supported by positive data from 4 phase 3 clinical trials. In each trial, BIC/FTC/TAC met its primary objective of non-inferiority, according to the release.

The 3 ongoing clinical trials were designed to assess the safety and efficacy of the investigational drug compared with triple-therapy regimens containing dolutegravir 50-mg. The studies include treatment-naïve patients and those switching to the experimental treatment.

Thee fourth ongoing clinical trial includes virologically suppressed patients who switch to BIC/FTC/TAC or remain on 2 nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor, Gilead reported.

A marketing authorization application for the investigational treatment will be submitted to the European Union during the third quarter of 2017, according to the release.

“We aim to simplify the management of HIV for a broad range of patients with this single tablet regimen that combines the potency of an integrase inhibitor, bictegravir, and the demonstrated long-term safety profile of the FTC/TAF backbone,” said Norbert Bischofberger, PhD, executive vice president, Research and Development and chief scientific officer of Gilead Sciences. “This regulatory filing is a demonstration of Gilead’s ongoing commitment to bringing forward treatment innovations that have the potential to address the needs of patients and physicians.”