Comparative safety and efficacy of BIC/FTC/TAF versus DTG+3TC in antiretroviral treatment-naive patients with HIV as first-line regimens: A real-world cohort study

Abstract

While bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir plus lamivudine (DTG+3TC) are first-line regimens for treatment-naive people with HIV (PWH), long-term real-world head-to-head comparisons of their metabolic and renal outcomes remain limited. We conducted a retrospective cohort study of ART-naive PWH initiating these regimens in China, utilizing 1:2 propensity score matching (PSM) to balance baseline covariates for 1,445 participants (901 BIC/FTC/TAF; 544 DTG+3TC). Over a 24-month follow-up, the study demonstrated comparable virologic suppression (99.7% vs. 100.0%; p = 0.623), weight changes, and cumulative incidence of metabolic abnormalities between the two groups. Conversely, although the crude 24-month incidence of eGFR decline was higher with DTG+3TC (54.8% vs. 40.7%; p = 0.039), adjusted Cox models revealed that the regimen was not independently associated with this decline (HR 1.20; 95% CI 0.97–1.48; p = 0.18).These findings indicate that both regimens offer comparable long-term virologic efficacy and metabolic safety profiles, supporting their routine clinical utility while highlighting the need for cautious interpretation of renal markers during integrase inhibitor-based therapy.