European Medicines Agency Validates Single Tablet Regimen Filing for HIV

The European Medicines Agency (EMA) fully validated a Marketing Authorization Application (MAA) for the HIV-1 combination treatment bictegravir plus emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).

Data from phase 3 trials showed that BIC/FTC/TAF demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in treatment-naïve adults and virologically suppressed adults 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,” Norbert Bischofberger, PhD, executive vice president of Research and Development and chief scientific officer at Gilead, said in a press release. “Gilead remains at the forefront of driving innovation in HIV, without continued commitment to working to simplify and improve treatments for people living with HIV.”

The MAA contains data from 4 phase 3 clinical trials, which showed that BIC/FTC/TAF met its primary objective of non-inferiority at 48 weeks.

Three of the studies are ongoing, and investigators are examining the safety and efficacy of BIC/FTC/TAF compared with triple-therapy regimens that contain 50 mg of dolutegravir. Two of 3 studies include treatment-naïve patients and the third contains patients who are virologically suppressed.

The fourth ongoing study includes virologically suppressed patients and is designed to compare switching to BIC/FTC/TAF versus remaining on a suppressive regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor, according to the release.

The EMA will review the BIC/FTC/TAF MMA filing under the centralized licensing procedure for all 28 member states of the European Union, plus Norway and Iceland. In the United States, a New Drug Application was submitted for BIC/FTC/TAF on June 12, 2017.