Abstract Background We compared the effectiveness and safety profiles of doravirine, lamivudine, tenofovir disoproxil fumarate (DOR/3TC/TDF) with bictegravir, emtricitabine, tenofovir alafenamide fumarate (BIC/FTC/TAF) in people with HIV (PWH) who had achieved virological suppression on efavirenz (EFV)-based antiretroviral regimens. Methods This study was a single-center, real-world, prospective observational cohort study. The main inclusion criteria: PWH aged ≥18 years who had received an EFV-containing regimen for ≥6 months and achieved confirmed virological suppression. Participants were stratified according to clinical decisions to switch to DOR/3TC/TDF or BIC/FTC/TAF. The primary effectiveness end point was the proportion of participants with HIV-1 RNA ≥50 copies/mL at week 48, with a preset 4% noninferiority margin. Results A total of 349 participants received at least 1 dose of study drugs (142 in DOR group, 207 in BIC group). At 48 weeks, 2 (1.4%) in the DOR group and 1 (0.5%) in the BIC group had HIV-1 RNA ≥50 copies/mL (estimated treatment difference ETD, 1.0%; 95% CI, −1.6% to 3.7%), establishing noninferiority. In the BIC group, mean CD4 counts decreased significantly by ∼76.5 cells/µL at week 48 (95% CI, −111.801 to −41.218; P .001) compared with baseline. Over 48 weeks, adverse event rates were comparable between the 2 groups (P = .758). At week 48, the BIC group exhibited a baseline-adjusted mean increase of 0.269 mmol/L in total cholesterol (TC) and 0.171 mmol/L in low-density lipoprotein cholesterol (LDL-C), while the DOR group demonstrated a mean reduction of 0.453 mmol/L in triglycerides (TG), 0.412 mmol/L in TC, and 0.241 mmol/L in LDL-C relative to baseline. All β values for the group–time interaction terms were negative (P .001). The change in body weight from baseline to week 48 in the DOR group was 1.8 kg lower than that in the BIC group (95% CI, −2.474 to −1.114; P .001). Conclusions In previously virologically suppressed PWH on an EFV-based regimen, the switch to DOR/3TC/TDF maintained virological suppression noninferior to that of BIC/FTC/TAF, with favorable metabolic profiles.
Li et al. (Fri,) studied this question.