Journal of Pharmacovigilance

Abstract

Adverse Effects and Regimen Switch among Patients on Antiretroviral Treatment in a Resource Limited Setting in Ethiopia

Gebrehiwot Teklay, Befikadu Legesse and Mebratu Legesse

Background: Highly active antiretroviral therapy is the cornerstone of management of patients with human immunodeficiency virus infection. Antiretroviral therapy can prolong survival of patients however this drugs are associated with adverse effects that can affect patient adherence and if severe may require regimen change. The aim of the study is to assess the prevalence of antiretroviral associated adverse effects and management strategies undertaken among patients taking antiretroviral therapy in Jimma University Specialized Hospital.
Methods: A retrospective review of patient medical records (2009-2011) was done to assess adverse effects associated with antiretroviral therapy. A sample of 403 patient medical records was selected using systematic random sampling method. Data was collected using structured data abstraction format. Data were entered into SPSS windows version 16 and chi-square test was used to analyze factors associated with adverse effects. P-value of less than 0.05 was considered as statistical significant.
Results: About 65.5% of patients had developed at least one adverse effect to antiretroviral drugs. The most commonly encountered adverse effects were gastrointestinal and central nervous system effects. Severe side effects that resulted in high rate of regimen switch and discontinuation included anemia, peripheral neuropathy, rash and hepatotoxicity.
Conclusion: Majority of patients taking antiretroviral therapy experienced mild to severe adverse effects in the course of treatment which can affect the patient treatment outcome. Thus close monitoring of toxicities considering the risk-benefit ratio of continuing, switching or discontinuation of treatment is critical.