Clinical Impact and Cost-Effectiveness of Rapid vs. Non-Rapid Initiation Antiretroviral Therapy Regimens in HIV-Positive Men Who Have Sex With Men in China: A Study Combining Modelling and 96-Week Multicenter Cohort Data

Background International treatment guidelines recommend rapid initiation of antiretroviral therapy (ART) for individuals newly diagnosed with HIV-1 infection; however, robust long-term real-world evidence remains limited in China. We aimed to evaluate the clinical outcomes and cost-effectiveness of efavirenz (400 mg) plus lamivudine and tenofovir disoproxil fumarate (EFV + 3TC + TDF) versus the coformulated bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in rapid (≤ 14 days from diagnosis) versus non-rapid (> 14 days) initiation among HIV-diagnosed men who have sex with men (MSM). Methods A real-world cohort of 301 ART-naïve HIV-positive MSM was stratified into four groups: rapid BIC (G1, n = 74), rapid EFV (G2, n = 77), non-rapid BIC (G3, n = 84), non-rapid EFV (G4, n = 66). Primary endpoint was CD4 + T-cell count change from baseline at weeks 48 and 96; secondary endpoints included viral suppression (< 50 copies/mL) and treatment persistence. Confounding was mitigated via the cloning, censoring, and weighting (CCW) method to emulate a randomized controlled trial (RCT), with cost-effectiveness analyzed using a hybrid economic evaluation model referencing China’s 2024 per capita GDP. Results At week 96, rapid initiation was associated with superior CD4 + T-cell recovery, particularly in the EFV-based regimen (mean difference: 144 cells/µL, p < 0.001 for rapid vs. non-rapid EFV). BIC/FTC/TAF demonstrated significantly better immunological recovery (mean difference: 151 cells/µL, p < 0.001 for non-rapid BIC vs. EFV) and higher treatment persistence (75.68%-84.52% vs. 53.25% for rapid EFV). Economic evaluation indicated a favorable profile for BIC/FTC/TAF. Conclusion Rapid ART initiation achieved excellent virological suppression, superior long-term immunological recovery, and cost-effectiveness. Compared with EFV + 3TC + TDF, BIC/FTC/TAF exhibited advantages in efficacy, economic value, and treatment persistence.