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ABSTRACT
Background
This study aimed to evaluate the therapeutic effect and tolerance of bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF) use for 24 weeks in anti-retroviral therapy (ART)-naïve patients in China.
Methods
This single-center retrospective cohort study included ART-naïve patients who received BIC/FTC/TAF from July 2021 to April 2022. The proportion of patients with HIV RNA < 50 copies/mL at the end point of 24 weeks (virological suppression rate) was the primary outcome, and the changes in CD4 cell count, CD4/CD8 ratio, weight, blood lipid, and safety were secondary outcomes.
Results
A total of 80 ART-naïve patients were enrolled. The virological suppression rate was 86.3% at 24 weeks. The median CD4 cell count increased from 212 cells/μL (interquartile range [IQR]: 90.3–398.3) at baseline to 348 cells/μL (IQR: 219.8–541.0) at 24 weeks. The median CD4/CD8 ratio increased from 0.25 (IQR: 0.13–0.37) at baseline to 0.40 (IQR: 0.26–0.66) at 24 weeks. During the follow-up of 80 ART-naïve patients using BIC/FTC/TAF, 16 participants had adverse events; however, these events did not lead to drug withdrawal.
Conclusion
This real-world cohort study showed that BIC/FTC/TAF could achieve good immunological and virological responses in ART-naïve patients. In addition, this study also shows good safety.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgments
The authors thank the site staff who supported the study.
Ethics statement
The Ethics Committee of Guiyang Public Health Clinical Center (202226) approved this study. The informed consent requirement was waived since the study was retrospective. This study complied with the Declaration of Helsinki.
Data availability statement
The data supporting this study’s findings are available from the corresponding author upon reasonable request.
Author contribution statement
Hai Long had full access to all of the data in the study and took responsibility for the integrity of the data and the accuracy of the data analysis. Lin Gan and Xiaoxin Xie were involved in the study concepts and design. All authors (Lin Gan, Xiaoxin Xie, Yanhua Fu, Yebing Song, Chunli Song, Tingting Ren, and Hai Long) were involved in data acquisition, analysis, and interpretation. Lin Gan and Hai Long supervised the analysis and were involved in the drafting of the manuscript. All authors read, critically revised and approved the manuscript.