Abstract:
Human immunodeficiency virus (HIV) infection has continued to be a challenge to
public health globally even though the overall growth of this epidemic has stabilized. Due to
increase in people receiving antiretroviral therapy (ART) there is a significant reduction in AIDSrelated morbidity and mortality. People infected with HIV are now living longer, and healthier
life. However significant number of patients discontinue their initial HAART regimen because of
adverse drug reaction.
Objective: To assess patterns and determinants of adverse drug reaction among adult patients on
HAART at MTUTH, Tepi General Hospital and G/Tsadik Shawo general hospital, Southwest
Ethiopia.
Methods: Facility based retrospective cohort study was conducted among peoples living with
HIV/AIDS receiving antiretroviral therapy. The data were entered into Epidata manager version
4.0.2 and analyzed using SPSS version 26. Both bivariate and multivariable Cox proportional
hazard models were used to identify predictor variables. Variables with p-value 0.25 and less in
the bivariate analysis were entered into the multivariable proportional hazard model. P-values less
than 0.05 and the corresponding hazard ratio with its 95% confidence intervals (CI) in the
multivariable Cox proportional hazards model were considered to be significantly associated with
the timing of ADRs.
Results: Of the total 1182 patients followed retrospectively for the last five years, 164(13.87%)
had experienced ADRs. One hundred seventeen (71.43%) of the total ADRs occurred in the first year of
ART initiation while 28(17.07%) occurred in the second year of ART initiation. Females were
2.31 times at risk of developing ADR compared to males. The odds of ADR development among
patients who never attended formal education were 2.84 times higher than those who attended
secondary school and above. Smokers were 3.47 times more likely to develop ADR compared to
non-smokers. Patients with WHO clinical stage III and IV were 3.61 times at higher risk of getting
ADR compared to those who were at stage I and II. Participants who did not receive
cotrimoxazole prophylaxis were at 2.65 times odd of having ADR compared to those who
received the prophylaxis. Patients who were non-adherent to HAART regimen were 2.13 times
more likely to develop ADR compared to those who adhered to their medication while those who
did not get isoniazid prophylaxis were at 1.72 times odd of developing ADR compared to those
who received this prophylaxis.
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Conclusion: The risk of adverse drug reaction among the study participants was high in the early
years of ART initiation and it decreased over the time of treatment. Patients’ sex, educational status,
smoking status, WHO clinical stage, cotrimoxazole prophylaxis, adherence to HAART
regimen and isoniazid prophylaxis were the independent predictors of ADR risk.
