Main Article Content
Background: The introduction of antiretroviral therapy (ART) hasresulted in significant mortality reduction and improvement in thequality of life. However, this has come at a cost of increased drugtoxicity. The objective of this study was to assess the patterns andpredictors of ART toxicity in adult HIV patients in Ethiopia.Methods: This is a prospective cohort study conducted at seventeaching hospitals between September 2009 and December 2013involving 3921 HIV patients on ART. Adverse drug reactions(ADR) due to ART were identified based on clinical assessmentand/or laboratory parameters. Multivariable random effectsPoisson regression analysis was used to identify factorsindependently associated with toxicity.Result: ADR due to ART drugs was reported in 867 (22.1 %) of theparticipants; 374 (9.5%) had severe forms. About 87% of reportedtoxicities were limited to three organ systems – the skin, nervoussystem and blood. The overall incidence of ADR was 9 per 100person years. About a third of toxicities occurred during the firstsix months after ART initiation with the incidence rate of 22.4 per100 person years. Concomitant anti-tuberculosis treatment was thestrongest independent predictor of toxicity.Conclusion: ADR was found to be highly prevalent in HIV patientson ART at tertiary hospitals in Ethiopia. Most of these conditionsoccurred early after ART initiation and in those with concomitantanti-tuberculosis treatment. Thus, routine monitoring of patientson ART should be strengthened with particular emphasis in thefirst 6 months. Strategies should also be devised to replace olderand more toxic agents with newer and safer drugs available.