Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Patients With HIV-1 Infection and Ongoing Substance Use Disorder: The BASE Study. (12th February 2023)

• Record Type: Journal Article
• Authors: Havens, Joshua P; Bares, Sara H; Lyden, Elizabeth; Podany, Anthony T; Scarsi, Kimberly K; Fadul, Nada; Swindells, Susan
• Is Part Of: Open forum infectious diseases. Volume 10:Number 3(2023)
• Publication Date: 2023-02-12
• Subjects: bictegravir/emtricitabine/tenofovir alafenamide -- HIV -- substance use disorder; Communicable diseases -- Periodicals; Medical microbiology -- Periodicals; Infection -- Periodicals; 616.9
• DOI: 10.1093/ofid/ofad080
• Languages: English
• ISSNs: 2328-8957

Abstract

Abstract: Background: People with human immunodeficiency virus (HIV) and substance use disorder (PWH/SUD) are at higher risk of nonadherence to antiretroviral therapy. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) exhibits high rates of efficacy with a favorable adverse event profile. The BASE study (NCT03998176) is a phase 4, single-arm study evaluating the effectiveness and safety of B/F/TAF among PWH/SUD. Methods: Viremic (HIV RNA >1000 copies/mL) PWH/SUD initiated B/F/TAF once daily for 48 weeks (W). The primary endpoint was proportion of participants with HIV RNA <50 copies/mL at W24. Secondary endpoints were proportion of participants with HIV-1 RNA <50 copies/mL at W48, safety, B/F/TAF adherence (dried blood spot [DBS] concentrations of emtricitabine triphosphate and tenofovir diphosphate [TFV-DP]), substance use (NIDA-ASSIST), and quality of life (SF-12). Results: Forty-three participants were enrolled; 95% reported methamphetamine use. Median age was 38 (range, 21–62) years; 21% were female, 81% White, 14% Black, and 16% Hispanic. Thirty-two (74%) and 21 (49%) participants had HIV RNA <50 copies/mL (intention-to-treat) at W24 and W48, respectively. Seven participants (16%) experienced confirmed virologic failure through W48; 1 developed emergent drug resistance (M184V). Fifteen participants (35%) experienced grade ≥3 adverse events. Five participants (12%) reported suicidal ideation; none resulted in discontinuation. Median DBS concentrations were representative of 5–6 doses/week (TFV-DP, 1603 fmol/punches). NIDA-ASSIST scores declined from baseline to W48 with methamphetamine use decreasing most (−7.9 points; −29%), and SF-12 physical/mental scores increased 1.2 and 7.6 points, respectively. Conclusions: B/F/TAF among a high-risk population of PWH/SUD resulted in an initial 72% viral suppression rate at W24 before dropping to 49% at W48 as retention declined. One participant developed emergent drug resistance (M184V). Abstract : Use of bictegravir/emtricitabine/tenofovir alafenamide among people with HIV and substance use disorder was safe and effective, with low rates of emergent HIV drug resistance despite incomplete adherence and declining retention to visits.