Week 48 Results from Dolutegravir/Lamivudine Versus Bictegravir/Emtricitabine/ Tenofovir Alafenamide Fumarate: Real-World Assessment of Weight Gain in Naïve People Living with HIV of Asian OrigiN (Dragon)

Several studies have demonstrated that significant weight gain occurs in some people living with HIV (PWH) after initiating integrase strand transfer inhibitors (INSTIs). Most studies on weight change have been clinical trials primarily focused on Africa, Europe, and North America, with limited representation from real-world studies in Asia. This retrospective observational study, conducted at nine designated HIV-care hospitals from March 2019 to January 2024, aimed to address this gap. Of the 533 patients screened, 314 met the criteria for the BIC/FTC/TAF group, while 181 qualified for the DTG/3TC group. At week 48, 86.3% of patients in the DTG/3TC group and 84.8% in the BIC/FTC/TAF group achieved HIV RNA <50 copies/mL (difference: 1.5%; 95% CI: -5.4% to 8.4%; p=0.67, evaluated in a snapshot, per-protocol-exposed population), meeting the criteria of non-inferiority. After calculating inverse probability of treatment weights, logistic regression analysis identified the following risk factors for weight gain of ≥10% at week 48: BIC/FTC/TAF (aOR 1.72; 95% CI: 1.16–2.54; p<0.01), CD4 counts <200 cells/uL (aOR 2.00; 95% CI: 1.32–3.03; p<0.01), HIV RNA ≥100,000 copies/mL (aOR 2.05; 95% CI: 1.37–3.07; p<0.01), and BMI <24 (aOR 3.51, 95% CI: 2.29–5.37, p<0.01). In conclusion, the study demonstrates that INSTIs, particularly BIC/FTC/TAF, may lead to significant weight gain in Asia. Furthermore, consistently high and comparable effectiveness was observed in both the BIC/FTC/TAF and DTG/3TC groups. Prospective studies involving a larger number of patients are warranted to further explore these findings.