Enhanced immune recovery with B/F/TAF compared with DTG/3TC in HIV patients: A prospective observational study.

OBJECTIVE: Real-world data on the efficacy, safety, and impact of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) and Dolutegravir/Lamivudine (DTG/3TC) in HIV patients remain limited in China. This study intends to address these gaps to inform antiretroviral therapy (ART) selection and improve patient care.

METHODS: A single-center, prospective observational study was conducted in Nantong Third People's Hospital. Patients initiating ART with either B/F/TAF or DTG/3TC between January 1, 2021, and December 31, 2023, were enrolled. Comprehensive baseline and follow-up data, consisting of demographic characteristics, HIV-related metrics, and biochemical parameters, were collected and analyzed.

RESULTS: Among 212 patients (140 on B/F/TAF and 72 on DTG/3TC), baseline characteristics were comparable. At week 48, both the B/F/TAF and DTG/3TC regimens achieved comparable virological suppression rates (91.42 % vs. 91.67 %, P = 0.953). However, the median increase in CD4 cell count was significantly higher with B/F/TAF (137 cells/µL) compared with DTG/3TC (112 cells/µL; P = 0.030). Logistic regression analysis further supported these findings, showing that the B/F/TAF regimen was significantly associated with immune recovery at week 48. The unadjusted odds ratio (OR) for immune recovery was 2.06 (95 % confidence interval: 1.10-3.87). This association remained significant after adjusting for gender, age, BMI, WHO stage, baseline CD4 count, HIV RNA, and additional laboratory results. No significant differences were observed in biochemical parameters or adverse events between the groups.

CONCLUSIONS: These findings underscore the clinical advantages of the B/F/TAF regimen in promoting immune reconstitution among HIV patients. Future studies should investigate whether the observed differences in immune recovery translate into reduced morbidity and mortality rates over time.