Metabolic Effects of Switching from TAF/FTC/RPV to BIC/TAF/FTC in Real-World Clinical Setting

Abstract Background As people living with HIV (PWH) age, the prevalence of comorbidities such as cardiovascular disease, diabetes, and dyslipidemia is increasing, leading to greater polypharmacy. Lifelong antiretroviral therapy (ART) therefore requires regimens that are not only virologically effective and well tolerated, with a high genetic barrier and minimal drug–drug interactions, but also metabolically neutral. Since antiretroviral drugs may influence metabolic parameters, the selection of regimens with a favorable cardiovascular and metabolic profile is of growing importance. This study evaluated the efficacy, safety, tolerability, and metabolic impact of switching from TAF/FTC/RPV to BIC/TAF/FTC in a single-center real-life cohort. Methods We conducted a retrospective analysis of 126 PLWH who switched from TAF/FTC/RPV to BIC/TAF/FTC between June 2020 and January 2025. Virological efficacy, safety, and tolerability were assessed over 48 weeks. Metabolic and cardiovascular effects were evaluated by changes in FINDRISC and ASCVD risk scores at week 48, as well as by variations in lipid profile, glucose levels, body weight, body mass index (BMI), and renal function. Results The cohort included 126 patients, 82% male, with a median age of 57 years (IQR 52–65) and a median of three prior ART regimens. At baseline, all participants had HIV-RNA < 20 copies/mL and a median CD4 + T-cell count of 872 cells/µL (IQR 646–1093). At least one comorbidity was present in 89.7% of patients, most commonly cardiovascular (36.3%), bone (32.3%), central nervous system (18.6%), liver (16.2%), lipid disorders (25.7%), and glucose metabolism alterations (10.9%); 16% had HBV coinfection. No virological failures were observed during follow-up. Treatment discontinuation occurred in four patients due to death (one prostate cancer) or intolerance (three cases: insomnia, gastrointestinal disorder, headache). No significant changes were observed in FINDRISC or ASCVD scores at week 48. Lipid parameters, glucose levels, and creatinine remained stable over time. Conclusions Switching from TAF/FTC/RPV to BIC/TAF/FTC maintained virological suppression and demonstrated good safety and tolerability, with no clinically significant impact on metabolic or cardiovascular risk over 48 weeks