Bictegravir 30mg / Emtricitabine 120mg / Tenofovir alafenamide 15mg tablets

BackgroundTreatment guidelines recommend rapid antiretroviral therapy (ART) initiation among eligible people with HIV to improve treatment outcomes and reduce HIV transmission. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), an integrase strand transfer inhibitor-based single-tablet regimen, is recommended for rapid start in US and European guidelines. This systematic literature review synthesized evidence on the efficacy, safety and effect on patient-reported outcomes (PROs) of B/F/TAF rapid start among newly diagnosed people with HIV.MethodsMEDLINE, Embase, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials databases were searched in January 2024, supplemented by searches of conference proceedings and clinical trial records. English-language interventional studies of B/F/TAF rapid start among ART-naïve people with HIV reporting efficacy, safety or PROs were eligible. Study quality was assessed using York Centre for Reviews and Dissemination or Risk Of Bias In Non-randomized Studies of Interventions checklists. Results were synthesized narratively.ResultsAcross eight included studies, 745 people with HIV received B/F/TAF rapid start, 171 received rapid start comparators and 255 received non-rapid start comparators. At Weeks 24 and 48, 80%-94% and 74%-96% of people with HIV treated with B/F/TAF rapid start achieved viral load ConclusionsB/F/TAF rapid start was efficacious, safe and associated with high engagement in care and improved PROs.

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Abstract Background Doravirine/islatravir is an investigational regimen that is being studied for human immunodeficiency virus type 1 (HIV-1) treatment. Methods In this phase 3, double-blind, double-dummy trial (ClinicalTrials.gov NCT04233879), previously untreated adults with HIV-1 were randomized (1:1) and stratified by HIV-1 RNA (≤/>100 000 copies/mL) and CD4 count (</≥200 cells/µL) to doravirine/islatravir (100/0.75 mg) or bictegravir/emtricitabine/tenofovir alafenamide (50/200/25 mg) orally once-daily (primary endpoint: percentage of participants with HIV-1 RNA <50 copies/mL at week 48; US Food and Drug Administration snapshot, 10% noninferiority margin). Results Overall, 597 participants were treated; enrollment stopped early due to decreases in CD4 and lymphocyte counts observed in other islatravir studies. Doravirine/islatravir was noninferior to bictegravir/emtricitabine/tenofovir alafenamide: 265 of 298 (88.9%) versus 264 of 299 (88.3%) had HIV-1 RNA <50 copies/mL (difference, 0.5%; 95% confidence interval [CI]: −4.7, 5.6). Mean change from baseline in CD4 count was +182 and +234 cells/µL (difference, −50; 95% CI: −79, −21) with doravirine/islatravir versus bictegravir/emtricitabine/tenofovir alafenamide. Mean change in lymphocyte count was 0.01 and 0.21 × 109/L (difference, −0.20; 95% CI: −0.30, −0.10). Adverse events (AEs) occurred in 90.6% and 87.3% of participants, with coronavirus disease 2019 being most common (14.1%, 16.4%). Treatment-related AEs were similar (28.9%, 25.8%). AEs that led to discontinuations were higher with doravirine/islatravir (8.7%, 3.7%) due to protocol-specified criteria that required discontinuation for decreased CD4 and lymphocyte counts. Conclusions Doravirine/islatravir (100/0.75 mg) once-daily was noninferior to bictegravir/emtricitabine/tenofovir alafenamide through week 48 for initial HIV-1 treatment. Due to decreases in CD4 and lymphocyte counts, development of this dose of doravirine/islatravir was stopped. Clinical Trials Registration NCT04233879.

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