Long-term efficacy and safety of fixed-dose dolutegravir-lamivudine in people with HIV: A retrospective study from India.

Abstract

BackgroundHIV continues to be a significant health concern across the world. Combination antiretroviral therapy (cART) comprising of three-drug regimens has improved clinical outcome but involves long-term toxicity concerns. Hence, to reduce drug exposure, interest in two-drug regimens has increased. This study evaluates the real-world efficacy and safety of a two-drug regimen that is a fixed-dose combination (FDC) of Dolutegravir 50 mg and Lamivudine 300 mg tablets in people living with HIV (PLHIV) in India.MethodsThe retrospective data included PLHIV aged ≥18 years, virally suppressed at baseline, and switched to DTG/3TC between November 2021 and April 2022. Patients were followed for 96 weeks, with routine clinical and laboratory assessments. Virological failure was defined as viral loads >1000 copies/mL, while safety assessments tracked adverse events (AEs), weight gain, and metabolic parameters.ResultsAmong 218 patients (mean age 48.08 ± 10.58 yrs), 97.8% achieved virological suppression at 96 weeks with sustained virological suppression at key time points (24, 48, 72, and 96 weeks). CD4 counts improved significantly (p = .002), specifically in females. Body weight increased moderately, with 16.28% experiencing ≥10% weight gain by 96 weeks. Minor statistically significant variations in cholesterol, triglycerides, and creatinine levels were observed. Nine patients discontinued DTG/3TC due to AEs, primarily weight gain and gastrointestinal issues.ConclusionThe study demonstrates that the DTG/3TC FDC is an effective, safe, and well-tolerated regimen for maintaining virological suppression in real-world settings, supporting its viable use as a switching strategy in reducing drug exposure and managing long-term toxicity.