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

• DOI: 10.1111/hiv.13593
• Publication Date: 2023-12-27T05:44:11Z
• Authors: Stefan Esser; Jason Brunetta; Alexy Inciarte; Itzchak Levy; Antonella D'Armin...; John S. Lambert; Berend van Welzen; Katsuji Teruya; Marta Boffito; Chun‐Eng Liu; Ozlem Altuntas Aydın; David Thorpe; Marion Heinzkill; Andrea Marongiu; Tali Cassidy; Richard Haubrich; Lisa D'Amato; Olivier Robineau
• Keywords: Emtricitabine; Tenofovir alafenamide; Regimen; Tolerability; Clinical endpoint

Abstract Background Real‐world evidence is an essential component of evidence‐based medicine. The aim the BICSTaR (BICtegravir Single Tablet Regimen) study to assess effectiveness and safety bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in antiretroviral treatment‐naïve (TN) treatment‐experienced (TE) people with HIV. Methods a prospective, observational cohort study. Participants (≥18 years) are being followed for 24 months. A pooled analysis presented at 12 months, primary endpoint (HIV‐1 RNA <50 copies/mL) secondary endpoints tolerability (as per protocol). An exploration patient‐reported outcome measures using standardized questionnaires included. Results Between June 2018 May 2021, 1552 HIV were enrolled across countries. analysed population comprised 1509 individuals (279 TN, 1230 TE); most white (76%), male (84%) had one or more comorbid conditions (68%). Median age was 47 years. After months B/F/TAF treatment, HIV‐1 copies/mL 94% (221/236) TN participants 97% (977/1008) TE participants. CD4 cell count increased by 214 cells/μL ( p < 0.001) 13 = 0.014) participants; median CD4/CD8 ratios 0.30 0.03, respectively (both 0.001). Persistence high (TN, 97%; TE, 95%). No resistance emerged. Study drug‐related adverse events occurred 13% through leading discontinuation 6%. Conclusions findings this provide robust real‐world support broad use both