Background: Large-scale, multicenter, long-term real-world studies investigating the associations between bictegravir (BIC)/emtricitabine (FTC)/tenofovir alafenamide fumarate (TAF) (B/F/TAF) versus dolutegravir (DTG)-based regimens and virologic, immunologic, metabolic outcomes, and mortality in people with HIV (PWH) are scarce.
Methods: Our study incorporates anonymized clinical records of PWH who newly started antiretroviral therapy (ART) in 19 centers across China. We retrieved data for PWH who initiated ART between January 1, 2020 and December 31, 2023. Inclusion criteria: baseline age ≥18 years, ART naïve, and initiated one of the following regimens: B/F/TAF, DTG+ tenofovir disoproxil fumarate (TDF) + lamivudine (3TC) (DTG+TDF+3TC), or DTG/3TC. Poisson regression models with time offset and robust variance were used to estimate adjusted incidence rate ratios (aIRRs) for virologic suppression (HIV RNA <50 copies/mL), all-cause mortality, AIDS-related mortality, and non-AIDS-related mortality, adjusting for key demographic and clinical variables. Linear mixed models with interaction terms (time-versus-treatment group) and restricted cubic splines with one knot at 1 year after ART initiation were used to evaluate differences in CD4 counts, CD4/CD8 ratios, body weight, blood glucose, triglycerides, and total cholesterol changes among treatment groups.
Findings: 13,895 Individuals (median age: 38 years [IQR 29-53], 86.6% male) were included. Compared to the B/F/TAF regimen, individuals initiating DTG+TDF+3TC were associated with an 8% increase in virologic suppression incidence (aIRRs 1.08, 95% CI 1.00-1.17), while those on DTG/3TC observed no significant differences. CD4 count and CD4/CD8 ratio were significantly smaller in the DTG/3TC group during the first year and over 2-4 years compared to B/F/TAF. DTG+TDF+3TC group were associated with significantly lower triglycerides (-0.41 mmol/L, 95% CI -0.48 to -0.35 in the first year; -0.06 mmol/L, 95% CI -0.12 to 0 over 2-4 years) and total cholesterol (-0.57 mmol/L, 95% CI -0.62 to -0.52 in the first year; -0.07 mmol/L, 95% CI -0.12 to -0.01 over 2-4 years) and less weight gain (-4.13 kg, 95% CI -4.73 to -3.54 in the first year; -1.39 kg, 95% CI -1.98 to -0.81 over 2-4 years) compared to B/F/TAF. All-cause mortality did not differ significantly between B/F/TAF and DTG+TDF+3TC users, but individuals who started DTG/3TC were observed to have a 37% higher all-cause mortality rate (1.37, 1.06-1.77) compared to B/F/TAF. Non-AIDS-related mortality was associated with 53% higher in DTG/3TC users (1.53, 1.15-2.03) compared to B/F/TAF. Among individuals with baseline weight >77 kg, each 10% increase in body weight at one year on ART was associated with 23% higher all-cause mortality and 38% higher non-AIDS-related mortality.
Interpretation: PWH initiating B/F/TAF in China were observed to have comparable virologic suppression compared to those starting DTG/3TC and DTG+TDF+3TC, although differences were observed in immunologic improvement, mortality rates, and metabolic changes. Subsequent weight gain after ART initiation merits heightened attention among individuals with higher baseline body weight.
Funding: National Key Technologies R&D Program of China.
Keywords: Bictegravir; China; Dolutegravir; Integrase strand transfer inhibitor (INSTI); Mortality; People with HIV (PWH).
© 2026 Published by Elsevier Ltd.