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.
