Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy) Approved for HIV Treatment

Bictegravir (BIC) is an unboosted HIV integrase inhibitor with a high in vitro barrier to resistance. The U.S. FDA has now approved the combination of BIC with emtricitabine and tenofovir alafenamide in a single-pill formulation (BIC/FTC/TAF; Biktarvy).

In phase III randomized trials in treatment-naive adults with HIV infection, virologic suppression with Biktarvy was noninferior to dolutegravir (DTG)/abacavir (ABC)/lamivudine (3TC) and DTG plus TAF/FTC (NEJM JW Infect Dis Nov 2017 and Lancet 2017; 390:2063). In randomized trials in people who were already virologically suppressed on a protease-inhibitor regimen or on DTG, ABC, and 3TC, Biktarvy maintained virologic control.

Biktarvy dosed as one pill per day is indicated for initial treatmen…