A randomised control trial of BIC/F/TAF vs DRV/c/F/TAF in context of HIV test-and-treat, BicTnT.

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  • Additional Information
    • Source:
      Publisher: Taylor & Francis Group Country of Publication: England NLM ID: 101738312 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2578-7470 (Electronic) Linking ISSN: 25787470 NLM ISO Abbreviation: HIV Res Clin Pract Subsets: MEDLINE
    • Publication Information:
      Original Publication: London : Taylor & Francis Group, [2019]-
    • Subject Terms:
      HIV Infections*/drug therapy ; HIV Infections*/virology ; Tenofovir*/therapeutic use ; Tenofovir*/analogs & derivatives ; Anti-HIV Agents*/therapeutic use ; Viral Load*/drug effects ; Emtricitabine*/therapeutic use; Humans ; Male ; Female ; Adult ; HIV-1/drug effects ; HIV-1/genetics ; Adenine/analogs & derivatives ; Adenine/therapeutic use ; Piperazines/therapeutic use ; Heterocyclic Compounds, 3-Ring/therapeutic use ; Heterocyclic Compounds, 4 or More Rings/therapeutic use ; Darunavir/therapeutic use ; Alanine/therapeutic use ; Alanine/analogs & derivatives ; Treatment Outcome ; RNA, Viral ; Sulfonamides/therapeutic use ; Middle Aged ; Cobicistat/therapeutic use ; United Kingdom ; Drug Combinations ; Amides ; Pyridones
    • Abstract:
      Background: Head-to-head data for bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF; B) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/F/TAF; D) are lacking in the context of rapid antiretroviral therapy (ART) initiation. This study, BIC-T&T, evaluates the efficacy and tolerability of B vs D in a UK test-and-treat setting.
      Setting: BIC-T&T was a randomised, open-label, multi-centre, study in which participants initiated ART within 14 days after confirmed HIV-1 diagnosis before baseline laboratory.
      Methods: The primary endpoint is the virological response (HIV RNA < 50copies/mL) at week 12 by time-weighted average change in log 10 HIV RNA recorded in viral load assays from treatment initiation to week 12, using two-sample Wilcoxon rank-sum test.
      Results: 36 participants were randomised: 94% were male, 53% white; mean (SD) age was 35 years (11.8). Baseline mean (±SD) log 10 HIV-RNA was 4.79 (± 0.87) log 10 copies/mL and CD4 505 (±253) cells/mm 3 . The mean (±SD) time from confirmed HIV diagnosis to ART initiation was 7.9 (± 3.7) days. The time-weighted mean decrease in log 10 HIV RNA from treatment initiation to week 12 was significantly greater in B in comparison to D (3.1 vs. 2.6 log 10 copies/mL, p  < 0.001). Both regimens demonstrated good tolerability with infrequent laboratory abnormalities and no grade 3 or 4 adverse events.
      Conclusion: In this first head-to-head study in the context of ART initiation, HIV RNA decline from baseline to week 12 was significantly more rapid for BIC/F/TAF compared with DRV/c/F/TAF.
    • Contributed Indexing:
      Keywords: BIC/ftc/taf; DRV/c/F/TAF; HIV infection; rapid ART strategy; test-and-treat
    • Accession Number:
      99YXE507IL (Tenofovir)
      0 (Anti-HIV Agents)
      G70B4ETF4S (Emtricitabine)
      JAC85A2161 (Adenine)
      0 (Piperazines)
      0 (Heterocyclic Compounds, 3-Ring)
      0 (Heterocyclic Compounds, 4 or More Rings)
      8GB79LOJ07 (bictegravir)
      YO603Y8113 (Darunavir)
      OF5P57N2ZX (Alanine)
      0 (RNA, Viral)
      0 (Sulfonamides)
      LW2E03M5PG (Cobicistat)
      0 (Drug Combinations)
      EL9943AG5J (tenofovir alafenamide)
      0 (Amides)
      0 (Pyridones)
    • Publication Date:
      Date Created: 20240908 Date Completed: 20240908 Latest Revision: 20241018
    • Publication Date:
      20241018
    • Accession Number:
      10.1080/25787489.2024.2400453
    • Accession Number:
      39244669