Adverse drug reactions causing treatment change among patients taking highly active antiretroviral therapy in health care facilities of Mekelle, Ethiopia

Adverse drug reactions to antiretroviral drugs have been identified as one of the major cause for non-adherence and change in regimen that in turn affects treatment outcomes negatively. This study was undertaken to determine the prevalence of adverse drug reactions to highly active antiretroviral therapy that result in change in regimen in two health care facilities (MH and MHC) in Mekelle, Ethiopia. A cross sectional retrospective study was conducted on a total of 3304 HIV patients currently on HAART, 2901 from MH & 403 from MHC. Data from patient information sheet were collected using pre-tested data collection format from April to May, 2009. Of the study subjects 1597 & 234 were females from MH & MHC respectively. The regimens used during the study period were ZDV/3TC/NVP, D4T/3TC/NVP, D4T/3TC/EFV and ZDV/3TC/EFV. Occurrence of ADR was the reason for change in regimen in 255 of the total 3304 patients; the prevalence of which was 8.31% in MH and 3.47% in MHC. The most common adverse reactions recorded were peripheral neuropathy, anemia & lipodystrophy in MH and anemia, skin rash & liver toxicity in MHC. High correlation was observed between being female and the occurrence of ADRs. This study has shown that the occurrence of ADR is a significant factor in changing regimens in health care facilities in Mekelle.