Authors
Stefan Esser, Jason Brunetta, Alexy Inciarte, Itzchak Levy, Antonella D'Arminio Monforte, 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
Publication date
2024/4
Journal
HIV medicine
Volume
25
Issue
4
Pages
440-453
Description
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 …
Total citations
20246
Scholar articles
S Esser, J Brunetta, A Inciarte, I Levy… - HIV medicine, 2024