Posted by Michael Wonder on 13 Jul 2018
Gilead receives approval in Canada for Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for the treatment of HIV-1 infection
12 July 2018 - Gilead Sciences Canada today announced that Health Canada has granted a notice of compliance for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) a once-daily single tablet regimen for the treatment of HIV-1 infection.
Biktarvy combines the potency of a novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy dual nucleoside reverse transcriptase inhibitor backbone, and is the smallest INSTI-based triple-therapy single table regimen available.
The approval of Biktarvy is supported by data from four ongoing Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults.
