Self-reported adverse drug reactions and their influence on highly active antiretroviral therapy in HIV infected patients: a cross sectional study.

Wondmagegn Tamiru Tadesse,Alemayehu Berhane Mekonnen,Wubshet Hailu Tesfaye,Yidnekachew Tamiru Tadesse

doi:10.1186/2050-6511-15-32

Wondmagegn Tamiru Tadesse, Alemayehu Berhane Mekonnen + Show 2 more

Open Access

https://doi.org/10.1186/2050-6511-15-32

Copy DOI

Abstract

BackgroundPatients on antiretroviral therapy have higher risk of developing adverse drug reactions (ADRs). The impact of ADRs on treatment adherence, treatment outcomes and future treatment options is quiet considerable. Thus, the purpose of this study was to describe the common self-reported ADRs and their impact on antiretroviral treatment.MethodsCross-sectional study was conducted at antiretroviral therapy (ART) clinic of Gondar University Hospital. Semi-structured interview questionnaire was used to extract self-reported ADRs, socio-demographic, and psycho-social variables. Variables related to antiretroviral medication, laboratory values and treatment changes were obtained from medical charts. Chi-square and odds ratio with 95% confidence interval were used to determine the associations of dependent variables.ResultA total of 384 participants were enrolled. At least one adverse drug reaction was reported by 345 (89.8%) study participants and the mean number of ADRs reported was 3.7 (±0.2). The most frequently reported ADRs were nausea (56.5%) and headache (54.9%). About 114 (31.0%) participants considered antiretroviral therapy to be unsuccessful if ADRs occurred and only 10 (2.6%) decided to skip doses as ADRs were encountered. Based on chart review, treatment was changed for 78 (20.3%) patients and from which 79% were due to documented ADRs (p = 0.00). Among them, CNS symptoms (27.4%) and anemia (16.1%) were responsible for the majority of changes. Around four percent of patients were non-adherent to ART. Non-adhered participants and those on treatment changes were not statistically associated with self-reported ADRs. Only unemployment status (AOR = 1.76 (1.15 - 2.70), p = 0.01) and ADR duration of less than one month (AOR = 1.95 (1.28-2.98), p = 0.001) were significantly associated with self-reported adverse effects of three or more in the multivariate analysis.ConclusionSelf-reported ADRs to antiretroviral therapy are quite common. More of the reactions were of short lasting and their impact on adherence and treatment change were less likely. However, documented ADRs were the most prevalent reasons for ART switch. Moreover, the level of unemployment was a strong predictor of self-reported ADRs.

Highlights

Patients on antiretroviral therapy have higher risk of developing adverse drug reactions (ADRs)
The level of unemployment was a strong predictor of self-reported ADRs
Few studies try to look the association between socio-demographic variables and adverse drug reactions, our study showed no difference in reported ADRs between age and sex differences

Summary

Introduction

Patients on antiretroviral therapy have higher risk of developing adverse drug reactions (ADRs). The clinical benefits of HAART is characterized by increased survival and longevity in HIV patients [5]. These clinical benefits are associated with aversive adverse drug reactions (ADRs). Edward and his colleague defined ADR as an appreciably harmful or unpleasant reaction resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product [6]

Objectives

Methods

Findings

Discussion

Conclusion