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Observational Study
. 2024 Apr;25(4):440-453.
doi: 10.1111/hiv.13593. Epub 2023 Dec 26.

Twelve-month effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV: Real-world insights from BICSTaR cohorts

Stefan Esser  1 , Jason Brunetta  2 , Alexy Inciarte  3 , Itzchak Levy  4 , Antonella D'Arminio Monforte  5 , John S Lambert  6 , Berend van Welzen  7 , Katsuji Teruya  8 , Marta Boffito  9 , Chun-Eng Liu  10 , Ozlem Altuntas Aydın  11 , David Thorpe  12 , Marion Heinzkill  13 , Andrea Marongiu  12 , Tali Cassidy  12 , Richard Haubrich  14 , Lisa D'Amato  15 , Olivier Robineau  16
Affiliations
Observational Study

Twelve-month effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV: Real-world insights from BICSTaR cohorts

Stefan Esser et al. HIV Med. 2024 Apr.

Abstract

Background: Real-world evidence is an essential component of evidence-based medicine. The aim of the BICSTaR (BICtegravir Single Tablet Regimen) study is to assess effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in antiretroviral treatment-naïve (TN) and treatment-experienced (TE) people with HIV.

Methods: BICSTaR is a prospective, observational cohort study. Participants (≥18 years) are being followed for 24 months. A pooled analysis is presented at 12 months, with the primary endpoint of effectiveness (HIV-1 RNA <50 copies/mL) and secondary endpoints of safety and tolerability (as per protocol). An exploration of patient-reported outcome measures using standardized questionnaires is included.

Results: Between June 2018 and May 2021, 1552 people with HIV were enrolled across 12 countries. The analysed population comprised 1509 individuals (279 TN, 1230 TE); most were white (76%), male (84%) and had one or more comorbid conditions (68%). Median age was 47 years. After 12 months of B/F/TAF treatment, HIV-1 RNA was <50 copies/mL in 94% (221/236) of TN participants and 97% (977/1008) of TE participants. Median CD4 cell count increased by 214 cells/μL (p < 0.001) in TN participants and 13 cells/μL (p = 0.014) in TE participants; median CD4/CD8 ratios increased by 0.30 and 0.03, respectively (both p < 0.001). Persistence was high at 12 months (TN, 97%; TE, 95%). No resistance to B/F/TAF emerged. Study drug-related adverse events occurred in 13% of participants through 12 months, leading to B/F/TAF discontinuation in 6%.

Conclusions: The findings of this study provide robust real-world evidence to support the broad use of B/F/TAF in both TN and TE people with HIV.

Keywords: ART‐experienced; ART‐naïve; B/F/TAF; antiretroviral therapy; bictegravir; real‐world evidence.

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References

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