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.
4 Drug Overview
5 Product Profiles
5 Biktarvy : HIV
LIST OF FIGURES
11 Figure 61: Datamonitor Healthcare’s drug assessment summary of fostemsavir for HIV
12 Figure 2: Datamonitor Healthcare’s drug assessment summary of Biktarvy for HIV
LIST OF TABLES
6 Table 1: Biktarvy drug profile
7 Table 2: Approval history of Biktarvy for HIV in the US, Japan, and five major EU markets
225 Table 85: Fostemsavir for HIV – SWOT analysis
10 Table 4: Biktarvy for HIV – SWOT analysis
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