+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

Biktarvy ([bictegravir + emtricitabine + tenofovir alafenamide (TAF)]; Gilead) Drug Overview 2019

  • PDF Icon

    Report

  • 16 Pages
  • June 2019
  • Region: Global
  • Citeline
  • ID: 4846138
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, the author 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.

Table of Contents

OVERVIEW
  • Drug Overview
  • Product Profiles
  • Biktarvy: HIV

LIST OF FIGURES
Figure 1: The author's drug assessment summary of fostemsavir for HIV
Figure 2: The author's drug assessment summary of Biktarvy for HIV
LIST OF TABLES
Table 1: Biktarvy drug profile
Table 2: Approval history of Biktarvy for HIV in the US, Japan, and five major EU markets
Table 3: Fostemsavir for HIV – SWOT analysis
Table 4: Biktarvy for HIV – SWOT analysis