Closing the Gaps in Pediatric and Adolescent HIV Care: Viral Suppression and Adverse Events after 2018 Antiretroviral Optimization in Uganda

Background : Despite the scale-up of Dolutegravir (DTG)-based regimens in sub-Saharan Africa, limited data exist on the real-world impact of antiretroviral therapy (ART) optimization on viral load suppression (VLS) and safety among children and adolescents. We evaluated regimen transitions, viral load trends, and safety outcomes among children and adolescents in HIV care at Mildmay Uganda Hospital (MUgH). Methods : We conducted a descriptive retrospective cohort study of children and adolescents aged ≤19 years receiving HIV care at MUgH between January 2018 and December 2023. Sociodemographic, clinical, and viral load data were abstracted from registers, patient files, and electronic medical records. Regimen transitions were classified into 11 groups, including Abacavir (ABC)/Zidovudine (AZT) to DTG, DTG to DTG, Efavirenz (EFV) or Nevirapine (NVP) to DTG, EFV or NVP to Protease Inhibitor(PI), EFV or NVP to PI/DTG, and PI to DTG, PI, or PI/DTG. Viral load was classified as suppressed (≤200 copies/mL), low-level viremia (201–999), or high-level viremia (≥1000). Descriptive statistics summarized baseline characteristics and regimen transitions. VLS before (2019) and after optimization (2022) was compared using chi-square tests. Adverse events were classified by Medical Dictionary for Regulatory Activities system organ class. Results : A total of 1,036 participants were included, with mean age 14.4 (±4.1) years; 58.0% were ≥15 years and 52.7% female. Most (94.4%) resided in the Kampala Metropolitan Area and 95.2% initiated ART at MUgH. Following optimization, viral suppression improved across multiple transitions: EFV→DTG (81.3% to 88.0%), PI→DTG (52.3% to 86.1%), ABC/AZT→DTG (65.6% to 90.6%), and NVP→DTG (80.6% to 88.8%). EFV→PI maintained 80.0% suppression, whereas NVP→PI consistently showed 100% high-level viremia. Overall suppression increased from 67.9% to 81.7% (p<0.001). Adverse events were predominantly Respiratory, thoracic and mediastinal disorders (49.2%), asymptomatic presentations (16.5%), and skin disorders (12.2%), with other events occurring at ≤2%. Conclusion: ART optimization at MUgH enhanced viral suppression, particularly with dolutegravir-based regimens, while protease inhibitor transitions showed slower improvement. Persistent viremia and frequent respiratory events highlight the need for vigilant monitoring, adherence evaluation and support, and timely interventions to sustain long-term treatment success among children and adolescents living with HIV.