Biktarvy

Drug Overview

Biktarvy ([bictegravir + emtricitabine + tenofovir alafenamide (TAF)]; Gilead) is an single-tablet regimen (STR) approved for the treatment of HIV-1 infection. It is a co-formulation of Gilead’s novel integrase strand transfer inhibitor (INSTI) bictegravir, and the marketed drug Descovy, which is a fixed-dose combination (FDC) of the nucleoside reverse transcriptase inhibitors (NRTIs) emtricitabine and TAF. TAF is a newly developed prodrug of tenofovir disoproxil fumarate (TDF) which is currently only available for the treatment of HIV as part of FDCs.

Although Biktarvy only demonstrated non-inferiority to regimens containing the integrase inhibitor Tivicay (dolutegravir; ViiV Healthcare), which has achieved blockbuster sales due to its best-in-class status, Datamonitor Healthcare believes that physicians’ familiarity with the F/TAF backbone will contribute to Biktarvy’s greater uptake over ViiV Healthcare’s Triumeq ([dolutegravir + abacavir + lamivudine]). Additionally, although Triumeq includes the high-resistance integrase inhibitor Tivicay, cardiovascular concerns relating to the Epzicom ([abacavir + lamivudine]) backbone, as well as hypersensitivity reactions for patients who are HLA-B*5701-positive, are anticipated to give a competitive edge to Biktarvy.