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Twenty-four month effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV: Real-world data from the BICSTaR Japan cohort.

Created on 08 Aug 2026

Authors

Dai Watanabe, Katsuji Teruya, Yoshiyuki Yokomaku, Rumi Minami, Tomoyuki Endo, Nao Taguchi, Johanna Ramroth, Andrea Marongiu, David Thorpe, Takuma Shirasaka, Shinichi Oka

Published in

Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy. Volume 32. Issue 9. Pages 103047. Aug 04, 2026. Epub Aug 04, 2026.

Abstract

BICSTaR (BICtegravir Single Tablet Regimen) is a multinational observational study assessing the virologic effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (HIV). Previously, the 12-month analysis of the Japan cohort of BICSTaR showed high levels of virologic effectiveness and tolerability with B/F/TAF.
Data for 84 treatment-experienced (TE) or 116 treatment-naïve (TN) participants aged ≥20 years receiving B/F/TAF as part of routine clinical care in Japan were collected retrospectively and prospectively. Outcomes analyzed at 24 months included HIV-1 RNA <50 copies/mL, treatment persistence, drug-related adverse events (DRAEs), and patient-reported outcomes (prospective cohort only).
At 24 months, 97% of TN and TE participants had HIV-1 RNA <50 copies/mL (missing-equals-excluded analysis), and 96% of participants remained in the study and were receiving B/F/TAF. DRAEs were reported by 14% of participants (TN: 16%; TE: 10%), with diarrhea (TN: 3%; TE: 2%) and weight gain (TN: 4%; TE: 0%) being the most common; the majority of DRAEs occurred in the first 12 months. Participants enrolled prospectively reported stable or improved quality of life through 24 months.
Treatment with B/F/TAF in routine HIV clinical care in Japan was associated with high persistence, virologic effectiveness, and was well tolerated through 24 months.

PMID:
42551554
Bibliographic data and abstract were imported from PubMed on 08 Aug 2026.

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