Incidence and predictors of sever adverse drug reactions among patients on antiretroviral therapy at Debre Markos Referral Hospital, Northwest Ethiopia

Background: Due to its nature of chronicity and the trend of using more drugs for patients with HIV, antiretroviral toxicity becomes a major challenge of HIV management. Evidences revealed that magnitude of experiencing at least one form of drug toxicity in different setting have been reached up to 90% among patients on antiretroviral therapy. The main aim of this study was to estimate the incidence and predictors of severe adverse drug reactions among People Living with Human Immunodeficiency Virus (PLHIV) at Debre Markos Referral Hospital. Methods: Retrospective follow up study with survival analysis was carried out among people living with Human Immunodeficiency virus. Mean survival time of the cohort was estimated using Kaplan-Meier method. To model the relationship between explanatory variables and the time to adverse drug reaction, Cox-proportional hazard regression model was fitted. Results: Out of the total 485 participants 67 (13.81%; 95% C.I: 10.7%, 16.8%) had experienced sever adverse drug reactions (ADRs). The incidence rate of severe adverse drug reaction development was 3 per 100-person years. Patients residing out of the catchment area to the facility were 73% at higher risk to develop ADR at any time, compared to those living within the catchment area (AHR=1.73; 95% C.I: 1.04, 2.86). The risk of ADRs among patients with baseline WHO clinical stage of III and IV was 2.59 times higher at any time compared to those with WHO stages I and II (95% C.I: 1.54, 4.36). Conclusion: The incidence of adverse drug reactions was relatively lower than reported in different parts of Ethiopia and other African countries. However, the overall burden in the 10 years period was still high. Health professionals working in the ART clinic need to give special attention for patients coming from outside of catchment areas, commercial sex workers and drivers and patients on advanced WHO clinical stages to prevent ADR development among these groups.