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Incidence and Predictors of Severe Adverse Drug Reaction Among Adult HIV Patients Initiated with Highly Active Antiretroviral Therapy in Northwest Ethiopia: A Retrospective Follow-up Study #MMPMID41369962
Begashaw S; Birhan TY; Zeleke EG; Abuhay HW
AIDS Behav 2025[Dec]; ? (?): ? PMID41369962show ga
Severe adverse drug reactions (ADRs) associated with antiretroviral therapy (ART) present a major public health challenge, particularly in resource-limited settings like Ethiopia where pharmacovigilance systems are often constrained. Despite the widespread rollout of ART, contemporary evidence on the incidence and predictors of these severe events in the Ethiopian context remains limited. This study aimed to determine the time to development of severe ADRs and identify their significant predictors among adults receiving ART in Northwest Ethiopia. A retrospective follow-up study was conducted, enrolling 634 HIV-positive adults who initiated ART between April 1, 2018, and March 31, 2023. Participants were selected using a stratified random sampling technique. Data were extracted meticulously from patient medical records and analyzed using STATA version 17. Survival analysis was performed using Kaplan-Meier curves and log-rank tests, while bi-variable and multivariable Cox proportional hazards regression models were carried out to identify independent predictors. Over a total follow-up period of 16,315 person-months, 29 patients developed severe ADRs, with the majority of incidents occurring within the first 9 to 21 months of treatment initiation. The overall incidence density was calculated at 18 per 10,000 person-months (95% CI: 12, 26). Multivariable analysis identified advanced baseline WHO clinical stage (III & IV) (Adjusted Hazard Ratio [AHR] = 9.86, 95% CI: 5.21, 13.24) and a low baseline CD4 count below 350 cells/muL (AHR = 3.21, 95% CI: 1.01, 5.43) as statistically significant predictors for a shorter time to severe ADR. The findings indicate that the risk is highest in the initial months of therapy and is strongly correlated with advanced disease stage and immunosuppression at baseline. This underscores the critical need for intensified clinical monitoring and counseling for high-risk patients, especially during the first year of ART, and highlights the urgency of strengthening national pharmacovigilance systems to improve patient safety outcomes.
AIDS+Behav 2025 ; ? (?): ?
