Time to Severe Adverse Drug Reaction and Predictors among Adults living with Human Immunodeficiency Virus on Highly Active Antiretroviral Therapy in Northwest Amhara

Abstract

Background: Antiretroviral therapy severe adverse drug reactions are the main public health problem, and cause morbidity, mortality and hospital admission. Updated information is scares in study area. Objective: The aim of this study was to determine time to development of severe adverse drug reactions and predictors among adults on antiretroviral therapy in Amhara region, Northwest Ethiopia. Methods: Institution based retrospective follow up study was conducted among patient on antiretroviral therapy between April1,2018 to March31, 2023.Data were collected and reviewed on 634 charts. We used stratified simple random sampling technique. The collected data were entered into Epi-data 4.6 and exported to STATA for analysis. Kaplan-Meier curve and log-rank test was done. Assumption of Cox proportional hazards model was checked, and Cox-Snell residual was used to test goodness of fit of the model. Bi-variable and multi variable cox regression models were performed to identify predictors of severe adverse drug reactions. Finally significant predictors were selected at P-value <0.05. Result: A total of 634 study participants followed retrospectively for the last five years. Onset of severe adverse drug reactions 29, 25(86.2%), 3(10.3%) and 1(3.4%) were occurred within 9 th , 15th and 21th months from the initiation of ART respectively. The incidence of severe adverse drug reaction was 18 per 10000 (95% CI: 0.0012, 0.0026) person months with a total follow up time of 16315 person months observations, baseline WHO clinical stage (lll&lV) (AHR = 9.86, 95% CI: 5.21, 13.24), patient baseline CD4 count less than 350 (AHR = 3.21, 95% CI: 1. 01, 5.43), were found to be significant predictors for time to development of severe adverse drug reaction. Conclusion: Severe adverse drug reaction was higher during the early stages of ART initiation time, and it decreases over the follow-up period of ART, older age, (primary & no) education, WHO stage(lll&lV), low CD4 count, and poor treatment adherence, were found to be significant predictor associated with time to development of severe adverse drug reaction.