Dolutegravir/lamivudine versus bictegravir/emtricitabine/tenofovir alafenamide fumarate: Real-world assessment of effectiveness and weight Gain in naïve people living with HIV of Asian OrigiN (DRAGON)

Abstract

Objectives: Among people living with HIV (PWH), the use of integrase strand transfer inhibitors (INSTIs) has been increasingly linked to notable weight gain, raising clinical concern. Much of the available evidence originates from trials in Western regions and Africa, while observational data from Asian settings remain scarce.

Methods: This retrospective, multicenter cohort study analyzed treatment-naïve PWH at eleven HIV care centers in Taiwan and mainland China between 2019 and 2025. Treatment-naïve patients initiating dolutegravir/lamivudine (DTG/3TC) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) were included. The primary endpoint was the proportion of patients with ≥10% weight gain. Secondary endpoints were virologic suppression (<200 copies/ml) between weeks 24-96 and changes in lipid profiles. Logistic regression with inverse probability weighting was used to identify the predictors of ≥10% weight gain.

Results: A total of 1087 patients were enrolled (DTG/3TC: 406; BIC/FTC/TAF: 681). Baseline CD4 counts were higher in the DTG/3TC group (315 vs 281 cells/µL, P = 0.01), while HIV RNA levels were lower (4.68 vs 4.96 log10 copies/ml, P < 0.01). Both regimens achieved comparable virologic suppression overall, including in participants presenting with advanced HIV disease. Weight gain was greater with BIC/FTC/TAF at week 48 (4.2 vs 2.2 kg; difference 2.0 kg; 95% CI: 1.1-2.9; P < 0.01) and week 96 (5.1 vs 2.8 kg; difference 2.3 kg; 95% CI: -1.1 to 3.5; P < 0.01). At week 48 and 96, 21.6% and 30.5% experienced ≥10% weight gain, respectively. After calculating IPTW, logistic regression analysis identified the following predictors included CD4 <200 cells/µL (aOR 2.54 and 2.89), BMI <24 kg/m² (aOR 2.59 and 2.35), and BIC/FTC/TAF (aOR 1.83 and 1.83) at week 48 and 96, respectively. At week 48 and 96, HDL cholesterol was significantly lower in the BIC/FTC/TAF group (mean differences = -2.4, and -2.4 mg/dl, respectively; P < 0.05).

Conclusion: In this large real-world Asian cohort, BIC/FTC/TAF and DTG/3TC demonstrated comparable virological efficacy. However, TAF-containing regimen-particularly among individuals with lower CD4 counts and BMI-were associated with greater weight gain and attenuated increases in HDL cholesterol, highlighting the need for careful metabolic monitoring.

Keywords: Asia; Bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF); Dolutegravir/lamivudine (DTG/3TC); Treatment-naïve adults living with HIV (PWH); Weight gain.