Study on the effectiveness and safety of BIC/FTC/TAF in adult HIV-1 patients in China: A retrospective real-world cohort study

Abstract

Abstract Background To evaluate the therapeutic effect and tolerance of BIC/FTC/TAF used for 24-week in ART-naïve in China. Methods This single-center retrospective cohort study included ART-naïve who received BIC/FTC/TAF from July 2021 to April 2022. The proportion of patients with HIV RNA < 50 cp/ml at the end point of 24-week (virological inhibition rate) was the primary outcome, and the changes of CD4 cell count, CD4/CD8, weight, blood lipid, and safety were secondary outcomes. Results A total of 80 ART-naïve were enrolled. The inhibition rate of virology was 86.3% 24-week. The median CD4 cell count increased from 212 cells/µL (90.3-398.3) at baseline to 348 cells/µL (219.8–541.0) at 24-week. The median CD4/CD8 ratio increased from 0.25 (0.13–0.37) at baseline to 0.40 (0.26–0.66) at 24-week. During the follow-up of 80 ART-naïve using BIC/FTC/TAF, 16 patients had adverse events; however, no drug withdrawal was caused by adverse events. Conclusion This real-world cohort study showed that BIC/FTC/TAF could achieve good immunological and virological responses in ART-naïve. In addition, this study also shows good safety.