Outcomes After Switching to BIC/FTC/TAF in Patients with Virological Failure to Protease Inhibitors or Non-Nucleoside Reverse Transcriptase Inhibitors: A Real-World Cohort Study

Abstract

Hui-Min Chang,1– 3 Pei-Yun Chou,4,5 Chen-Hsi Chou,2 Hung-Chin Tsai4– 6 1Department of Pharmacy, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; 2Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan; 3Department of Pharmacy and Master Program, Collage of Pharmacy and Health Care, Tajen University, Pingtung, Taiwan; 4Section of Infectious Diseases, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; 5National Yang Ming Chiao Tung University, Taipei, Taiwan; 6Institute of Biomedical Sciences, National Sun Yat-Sen University, Kaohsiung, TaiwanCorrespondence: Hung-Chin TsaiSection of Infectious Diseases, Department of Medicine, Kaohsiung Veterans General Hospital, #386 Ta-Chung 1st Road, Kaohsiung, 813, TaiwanTel [phone] ext. 2029Fax [phone]Email [email protected] ChouInstitute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, TaiwanEmail [email protected]: This study evaluated the real-world tolerability and treatment effectiveness of BIC/FTC/TAF in treatment-experienced patients living with HIV-1 in Taiwan, especially in those with viremia at switch.Patients and Methods: This was a retrospective cohort study of adult patients in Taiwan with HIV-1 who received BIC/FTC/TAF from between November 2019 and November 2020. The primary endpoint was the rate of viral suppression (plasma HIV RNA load < 50 copies/mL) while on BIC/FTC/TAF. The secondary endpoints included durability of treatment, incidence of and reasons for discontinuation of BIC/FTC/TAF, and changes in weight and lipid profiles.Results: A total of 175 patients were switched to BIC/FTC/TAF. Among them, 74 patients (42%) were using INSTI based regimen, 34 patients (19%) NNRTI based regimen and 65 patients (37%) with PI based regimen before switching. Before starting BIC/FTC/TAF, 84.6% of the patients were virologically suppressed, of whom 97.3% maintained suppression while on BIC/FTC/TAF. Overall, 15.4% of the patients (n=27) had a detectable viral load before BIC/FTC/TAF, of whom 81.5% achieved and maintained virologic suppression on BIC/FTC/TAF during follow-up. Only two patients discontinued BIC/FTC/TAF due to adverse events, with rash being the predominant cause. By month 12, the median changes in weight was +4 kg (IQR, − 1.8 to 8.2). There were no significant differences from baseline to the end of follow-up in triglycerides (p = 0.07), total cholesterol (p = 0.92), LDL-C (p = 0.12), and HDL-C (p = 0.053).Conclusion: The results of this real-world cohort study suggest that switching to BIC/FTC/TAF may be an option to achieve and maintain virological suppression, even in patients with residual viremia at baseline. Our results also demonstrated a low discontinuation rate, a moderate gain in weight, and no significant increases in lipid levels with BIC/FTC/TAF. However, studies with larger sample sizes are warranted to evaluate the clinical implications of our findings.Keywords: Biktarvy, bictegravir, switching, virological failure, viremia

Keywords

• biktarvy
• bictegravir
• switching
• virological failure
• viremia