European regulators are now reviewing Gilead’s fixed-dose combination of bictegravir (BIC), emtricitabine and tenofovir alafenamide as a treatment for HIV-1 infection.
The once-daily single tablet regimen, combing a novel investigational integrase strand transfer inhibitor with emtricitabine/tenofovir alafenamide (FTC/TAF), has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase III clinical trials involving treatment-naïve adult patients and among virologically suppressed adults who switched regimens.
The marketing application for BIC/FTC/TAF centres on data from four Phase III studies in which the regimen met its primary goal of non-inferiority to ViiV Healthcare’s flagship drug dolutegravir (DTG) 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; two in treatment-naïve patients and one in virologically suppressed patients 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.
“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,” noted Norbert Bischofberger, executive vice president, Research and Development, and chief scientific officer at Gilead.