Transition to generic dolutegravir: immunologic, virologic, and metabolic outcomes in a resource-limited setting

Dolutegravir (DTG) is a preferred antiretroviral agent; however, real-world data on outcomes after switching from branded to generic DTG remain limited. This study aims to evaluate metabolic, immunological, and virological outcomes following the transition from branded to generic DTG in HIV treatment programs in resource-limited settings. A longitudinal analysis was conducted among 188 people living with HIV (PLWH) who transitioned to generic DTG-based regimens. Clinical, immunological, virological, and metabolic parameters were assessed at multiple time points before and after the transition (median pre-transition 21.7 months; post-transition 10 months). Analyses covered four periods: pre-transition, 0-3, 3-6, and > 6 months post-transition. Primary outcomes were CD4 count change and viral suppression (undetectable viral load). Metabolic effects included changes in weight, BMI, lipid profile, and HbA1c. Linear and generalized linear mixed-effects models were applied. Following transition to generic DTG, CD4 counts continued to rise at 8.9 cells/µL/month (p < 0.001), particularly those with baseline CD4 < 200, with 74.5% of PLWH showing immunological improvement. Viral suppression was higher from 57.4% pre-transition to 71.8% at > 6 months post-transition. LDL increased slightly (+ 0.55 mg/dL/month, p < 0.001), while triglycerides (- 0.73 mg/dL/month, p = 0.03) and HbA1c (- 0.01%/month, p = 0.01) decreased. BMI and weight showed no significant changes. Adverse drug reactions occurred in 12.2%, most commonly sleep disturbance (4.89%). Transitioning from branded to generic DTG was associated with sustained immunological and virological outcomes and stable metabolic parameters. These findings support generic DTG as a safe, effective, cost-saving option for routine HIV care in resource-limited settings.