Impact of adverse events of antiretroviral treatment on regimen change and mortality in Ugandan children

BACKGROUND: Outcomes of antiretroviral treatment have been documented in both developed and developing countries. It has been reported consistently that the treatment is associated with many adverse events. However, little is known about their impact on the quality of life, clinical management, and survival in children aged less than 6 years in Uganda. OBJECTIVES: The purpose of this study was to determine the prevalence of the adverse events of antiretroviral treatment, their impact on mortality and the change in regimens prescribed to children treated at Mildway Centre in Uganda. METHOD: A retrospective chart review was performed for children younger than 6 years, treated since the Mildway Centre was opened in 1999. In order to achieve a larger sample, the records of children treated from January 2000 to July 2005 were included in the study. A pre-tested data collection form was used to collate socio-demographic and clinical data of the patients. These included the documented adverse events, causes of death, stage of infection, duration of treatment, regimen prescribed, year of enrolment into the treatment program, as well as whether or not they were still alive. Descriptive statistics were used in the analysis of data. RESULTS: Of the 179 children, the majority were males and had a median age of 4 years. The majority (58.8%) of children had suffered from severe immune depression since they met the WHO clinical stage III and IV, 73.8% had a baseline CD4T of less than 15%. Four regimens were prescribed to the children. The most common was a regimen containing zidovudine, lamivudine, and nevirapine (34.6%), followed by a regimen containing stavudine, lamivudine, and nevirapine (27.9%). Eleven children (6.1%) had their regimen changed, of which six (54.5%) were due to adverse events. The prevalence of adverse events was 8%; of the 14 documented adverse events, the most common were severe anaemia (3), vomiting (3), and skin rashes (3). After 12 months on treatment, 8% of the patients had died. The most common causes of death were infectious diseases (28.6%), severe anaemia (21.4%), and severe dehydration (21.4%). CONCLUSION: The prevalence of adverse events was 8%; they were responsible for 54.5% of regimen changes and 21.4% of deaths in children treated at the study site. These findings suggest the need for incorporating pharmacovigilance practices into the provision of antiretroviral treatment.