Incidence and Predictors of Sever Adverse Drug Reactions Among Patients on Antiretroviral Therapy at Debre Markos Referral Hospital, Northwest Ethiopia

Abstract

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.

The Incidence of Adverse Drug Reaction Among Adult Patients on Antiretroviral Therapy in Ethiopia: Frailty Model

“…This discordance might be due to the difference in follow-up time, in our case the follow-up time was five years, however, the study in India was a two years follow-up, which is less than half our study period, this might have contributed to large rates of ADRs as most of ADRs are likely to occur in the first one to two years of the follow-up period. Besides, the finding was higher than the study conducted in Northwest Ethiopia 27 where the incidence rate was 3/100 PY. This difference might be due to the difference in the definition of ADRs, in our case ADRs was defined as anemia, skin rash, pain (tingling) of extremities, vomiting, hepatotoxicity, jaundice; However, the study in Northwest Ethiopia defined ADRs as at least one of the following events: hospitalization, or switch/discontinuation of drug because of adverse drug reaction, this tight definition might contributed to lower rates of ADRs.…”

“…The WHO clinical stage of the patients was an important predictor of ADRs, where patients in the advanced clinical stage at the initiation of HAART were at higher risk of developing ADRs at any time compared to patients in clinical stage I. The finding is supported by the study conducted in Bahir Dar, Northwest Ethiopia 7 Debre Markos, Northwest Ethiopia 27 and India. 26 This could be because individuals in advanced clinical stages of the disease may be unable to withstand drug adverse effects, resulting in drug modifications or hospitalizations, thereby finding themselves at higher risk of drug reactions.…”

Incidence and Predictors of Severe Adverse Drug Reactions among Patients on Antiretroviral Drugs in Harari Regional State, Eastern Ethiopia

“…In this study, the incidence of severe ADRs is relatively higher than in the two studies conducted in the Northern parts of Ethiopia Tigray (3.6 per 100 person year) [24] and Amhara region (3 per 100 person-years) [22]. Tis difference may relate to the diference in follow-up time in which the follow-up time in our case is lower than that of the two studies.…”

“…Calculation. Te sample size of the study was determined for survival data, Cox proportional regression model by using Epi Info 7.0 by taking the percentage of exposed group and unexposed group who experienced severe adverse drug reactions 19% and 9%, respectively, from previous study conducted in Debre Markos referral hospital [22], with the consideration of the following assumption margin of error 5% and 95% confdence interval, power 80%, and by adding 10% of the loss to follow-up which gives 150 of exposed group and 299 of unexposed group and total sample size of 449 with a ratio of exposed to unexposed group 1 : 2. Te study settings were selected randomly, and lists of all eligible participants were obtained from ART clinics in the selected facilities and were used as the sampling frame.…”

“…A structured data extraction form was developed from ART follow-up charts and relevant literature and used [22][23][24][25]. Tree clinical nurses were deployed for data collection.…”