Adverse Events Among People Living With HIV Receiving Dolutegravir-Based Regimens: Findings From a 6-Month Active Pharmacovigilance Study in Uganda.

Background: Dolutegravir (DTG)-based antiretroviral therapy (ART) is recommended as first-line treatment for people living with HIV-1 (PLHIV) in Uganda. However, data on its safety profile in routine care remain limited. This study actively monitored adverse events (AEs) among PLHIV receiving DTG-based regimens, assessing factors associated with their occurrence. Methods: We conducted a prospective cohort study nested within a parent cohort from July 2021 to September 2022 across 3 Ugandan sites (urban, peri-urban, and rural). Adults on DTG/lamivudine/tenofovir (TLD), either transitioning from prior ART regimens or initiated on TLD as first-line therapy, were followed for 6 months. AEs were systematically captured using structured interviews and classified by the Medical Dictionary for Regulatory Activities System Organ Class. Univariable and multivariable logistic regression analyses identified predictors of AEs. Results: Among 607 participants, 50 (8.2%) reported adverse events (AEs). Neuropsychiatric disorders were most common (2.5%), followed by cardiovascular (1.8%) and reproductive system disorders (1.5%). Other AEs, including gastrointestinal, eye, and skin disorders, were rare (<1%). In multivariable analysis, participants at site 3 and being single had significantly lower odds of AEs (aOR 0.04, 95% CI 0.00-0.29, Conclusions: DTG-based ART regimens demonstrated a favorable safety profile, with AEs occurring infrequently and predominantly in neuropsychiatric, cardiovascular, and reproductive categories. Study site, Marital status and prior Zidovudine exposure were associated with AE risk, emphasizing the need for tailored monitoring, strengthened awareness in AE reporting and standardized pharmacovigilance across facilities.