Abstract:
Abstract
Introduction: Major adverse reactions due to antiretroviral therapy are the leading causes of
poor adherence, treatment discontinuation, and switching of drugs, thereby increasing morbidity
and hospitalization rates and further resulting in death. Despite this fact, there is a dearth of
information regarding the incidence and predictors of major adverse drug reactions among
children on antiretroviral therapy in Ethiopia.
Objective: This study aimed to assess the incidence and predictors of major adverse drug
reactions among Human Immunodeficiency virus infected children on antiretroviral treatment in
West Amhara region comprehensive specialized hospitals, Northwest Ethiopia, 2022.
Methods: A multicenter retrospective follow-up study was conducted among 460 children who
received antiretroviral treatment from January 1, 2014 to December 31, 2021. A simple random
sampling technique was employed and data were collected using kobo toolbox software from
May 11 to June 11, 2022 and then deployed to STATA 14 for analysis. The Kaplan-Meier
survival curve and the Log-rank test were used to estimate and compare the survival time.
Proportional hazard assumptions were checked using graphs and a Schonfeld residual test (pvalue
= 0.8621). Both bi-variable and multivariable Weibull regression models were fitted to
identify predictors. Finally, an AHR with a 95%CI was computed, and variables with a p-value
of < 0.05 were considered as statistically significant predictors of major adverse drug reactions.
Results: A total of 439 children records were included in the final analysis and observed for
12607.1 child-months follow-up period. From these, 73(16.63%) had developed major adverse
drug reactions and the overall incidence density rate was 5.8 (95% CI: 4.6, 7.3) per 1000 childmonths
of observations. Being female (AHR: 2.71, 95% CI: 1.52,4.84), TB-HIV co-infection
(AHR: 2.49, 95% CI:1.32,4.68), WHO stage (III and IV) (AHR:2.52, 95% CI: 1.39,4.56), AZTbased
(AHR:2.84,
95%CI:1.11,7.31), and D4T-based (AHR:5.96, 95% CI:1.63,21.84) regimens
were found to be significant predictors of major adverse drug reactions.
Conclusion and recommendation: There was a high rate of major adverse drug reactions and it
was especially high during the early months of antiretroviral treatment initiation. Hence, HIV
patients need to be closely followed in the first six months and emphasis would be given to
females, TB/HIV co-infection, advanced WHO disease stage, AZT and D4T-based regimens
children.
Keywords: Adverse drug reactions, antiretroviral therapy, children, Northwest Ethiopia
