Adverse drug reactions associated with antiretroviral treatment among adult Ethiopian patients in a tertiary hospital.

ABSTRACT

BACKGROUND: Adverse drug reactions (ADRs) are frequently encountered among patients taking Antiretroviral Treatment (ART). The aim of this study was to describe the type and frequency of ADRs among adult Ethiopians on ART. OBJECTIVE: to describe the type and frequency of short term adverse drug reactions among adult Ethiopian patients on ART at Tikur Anbessa teaching Hospital in Addis Ababa, Ethiopia. METHODS: From October 2008 to December 2009, 228 HIV positive patients were enrolled to a tertiary teaching hospital in Addis Ababa. Patients were closely monitored for ADRs for a median observation period of 18 weeks (79 total person-years of observation). Time-dependent occurrence of clinical adverse effects and abnormal laboratory values as defined by the AIDS Clinical Trial Group were analyzed (41). RESULTS: A total of 392 ARV drug related ADRs occurred Mild GI disturbances (36.8%) and headache (35.9%) were the most frequently reported symptoms. Thirty (7.7%) of the ADRs were severe requiring change or interruption of therapy (19 hematological and 11 hepatotoxic). Severe hematological complications were anemia (4.8%), neutropenia (2.6%) and thrombocytopenia (0.9%). Anemia occurred earl), in the first 4 weeks of ART treatment. Hepatic toxicity was also seen early but continued throughout the observation period, decreasing over time. Other ADRs encountered were grade I/II toxicities of rash, peripheral neuropathy, and metabolic disturbances. CONCLUSION AND RECOMMENDATIONS: ADRs occurred frequently in patients receiving ART. Grade III/IV toxicity that required withholding or change of treatment occurred in nearly 10% of the patients. Regular clinical, and laboratory monitoring appropriate to centers with limited resources need to be devised to monitor toxicity of ART Patient education on the easily recognizable ADRs could also reduce severe drug toxicities.