ORIGINAL RESEARCH article
Front. Virol.
Sec. Antivirals and Vaccines
Effectiveness and safety of bictegravir/emtricitabine/tenofovir 1 alafenamide fumarate for people with ultra-high viral load of HIV-1: 2 a retrospective real-world cohort study
Provisionally accepted
- 贵阳市公共卫生救治中心, Gguiyang, China
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Background:This study evaluated the effectiveness and safety of 10 bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in treatment-naïve 11 adults with HIV-1 and an ultra-high viral load (uVL; HIV-1 RNA ≥500,000 12 copies/mL)—a population at high risk for suboptimal outcomes. 13 Methods: A retrospective cohort study was conducted among 75 patients initiating 14 BIC/FTC/TAF. The modified intent-to-treat (mITT) group included all patients, while 15 the per-protocol (PP) group comprised 58 individuals who completed 96 weeks of 16 follow-up. Virological suppression, immunological response, safety, and resistance 17 were assessed. 18 Results: Virological suppression rates in the PP group were 98.3% at week 48 and 19 96.6% at week 96, compared to 74.7% and 78.7% in the mITT group—a gap largely 20 due to non-clinical dropouts. Immunological recovery was significant, with median 21 CD4+ counts increasing from 61.5 to 326.0 cells/μL (p<0.001).No 22 treatment-emergent resistance was detected. Adverse events were mild (6.9%). 23 Conclusion:BIC/FTC/TAF is highly effective and safe for adherent uVL patients, 24 demonstrating rapid viral suppression and immune recovery. However, real-world 25 effectiveness is significantly limited by socioeconomic barriers, highlighting the need 26 for improved programmatic support to enhance retention and treatment access.
Keywords: Bictegravir/emtricitabine/tenofovir alafenamide fumarate, hiv/aids, ultra-high viral load, efficacy, Safety
Received: 04 Jul 2025; Accepted: 29 Oct 2025.
Copyright: © 2025 He, Xie, Fu, He, Luo and LONG. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Xiangxi He, 850412886@qq.com
Hai LONG, longlong1225@126.com
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