Abstract:
Background: The introduction of combined antiretroviral therapy improves the life quality and life span of people living with HIV/AIDS (PLWH). However, the adverse drug reactions associated with antiretroviral therapy might impede the benefit that gains from it which is variably reported across the world and also in Ethiopia. Consequently, little is known about the problem in the current study area. This is therefore, to study the incidence and predictors of severe adverse drug reactions among patients on antiretroviral drugs the in Harari regional state, Eastern Ethiopia.
Objective: The aim of this study was to assess the incidence and predictors of severe adverse drug reactions among patients on antiretroviral therapy in Harari national regional state from February 25 to March 25, 2022 .
Methods: A hospital-based retrospective- cohort study was conducted among 449 randomly selected medical records of the people living with HIV on first line antiretroviral therapy who enrolled from January 1, 2018 to December 30, 2020 and have at least one repeated visit at the same facility. The computer generated simple random sampling technique was used to select the patient medical records using the unique antiretroviral number in both exposed and unexposed group. Data was collected using the adapted data extraction form from antiretroviral therapy follow-up charts and entered into Epidata version 3.1 and exported to STATA version 15 for analysis. Kaplan Meier survival curve with log-rank test was used to compare survival curves for categorical independent variables. A p value ≤ 0.05 declared as significant association and hazard ratio used to report the effect size.
Result: The overall incidence density of the severe adverse reactions was 0.722 per 100 months (0.00722) (95% CI: 0.0055, 0.0096). After adjusting for all potential confounder using multivariable cox proportional hazard ratio, advanced clinical diseases (AHR=3.44; 95% CI:1.54, 7.65), HIV/TB coinfections (AHR= 2.38; 95% CI: 1.23, 4.62) and being female (AHR=3.12; 95% CI: 1.57, 6.18) were significantly associated with experience of severe adverse drug reactions among patients on antiretroviral therapy in Harari, Eastern Ethiopia.
Conclusion: In this study the incidence of severe adverse reactions was consistent with the previous studies, advanced WHO clinical stage, HIV/TB Coinfection and being female were the independent predictors of the severe adverse drug reactions
