Gilead Sciences has announced that the company's Marketing Authorization Application (MAA) for an investigational, once-daily single tablet regimen containing bictegravir (50 mg; BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg; FTC/TAF) for the treatment of HIV-1 infection in adults has been fully validated and is now under evaluation by the European Medicines Agency (EMA).

BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in phase 3 clinical trials among treatment-naïve adult patients and among virologically suppressed adult patients who switched regimens.

"This investigational single tablet regimen represents a potential advance in HIV treatment by combining the potency of an integrase inhibitor, bictegravir, with the demonstrated safety profile of the FTC/TAF backbone," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "Gilead remains at the forefront of driving innovation in HIV, with our continued commitment to working to simplify and improve treatments for people living with HIV."

The MAA for BIC/FTC/TAF is supported by data from four phase 3 studies in which the regimen met its primary objective of non-inferiority at 48 weeks. Three of the ongoing studies are designed to explore the efficacy and safety of BIC/FTC/TAF compared to triple-therapy regimens containing dolutegravir (50mg; DTG); two in treatment-naïve patients and one in virologically suppressed patients (HIV-1 RNA levels <50 copies/mL) switching from an existing DTG-containing antiretroviral regimen. A fourth ongoing study in virologically suppressed patients compares switching to BIC/FTC/TAF versus remaining on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor.

The BIC/FTC/TAF filing will be reviewed by the EMA under the centralized licensing procedure for all 28 member states of the European Union, as well as Norway and Iceland.

Gilead submitted a New Drug Application (NDA) for BIC/FTC/TAF in the United States on June 12, 2017, and 48-week data from two phase 3 studies investigating BIC/FTC/TAF compared to regimens containing DTG in treatment-naïve adult patients will be presented at the International AIDS Society Conference on HIV Science (IAS 2017), July 23-26, 2017, in Paris.

Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally.