Background: There are 35 million people living with Human immunodeficiency virus (HIV) in the World. Kenya’s estimated HIV prevalence is 6 percent among people aged 15-49 years, 7.6 percent in women compared to 5.6 percent in men. There are 41.7 percent of adults on antiretroviral drugs (ARVs). Despite these drugs reducing morbidity and mortality, they have also resulted in adverse drug reactions (ADRs) which have affected patients’ adherence. Some of the documented reactions include hepatoxicity, mitochondrial toxicity, peripheral neuropathy, hypersensititvity reactions, anaemia and lipodystrophy syndrome among others. The Pharmacy and Poisons Board (PPB) in Kenya established a pharmacovigilance system in 2004 where these adverse reactions are monitored and reported by health professionals. The individual case safety reports (ICSRs) generated from these cases are sent to PPB. These reports are then forwarded to the World Health Organization Collaborating Centre for International Drug Monitoring, Uppsala for detection of safety signals from the ICSRs.
Objective: The main objective of the study is to analyse the individual case safety reports for severity, outcomes and risk factors associated with ADRs due to antiretroviral therapy (ART) from the spontaneous reporting database in patients who received ART in Kenya.
Methodology: This will be a retrospective cross-sectional study that will analyze 840 ICSRs on ART-related ADRs reported between January 2014 and December 2014 from the National Pharmacovigilance System at the Pharmacy and Poisons Board in Kenya (PPB). A data collection form will be used to extract information from the database on patient demographics, ADR description, suspected drug details, severity of reaction and outcome of the reaction before data entry and analysis. Patients will be assigned codes instead of their names. Review of the reports will be done at PPB to maintain patient confidentiality. Data analysis will be performed using STATA version 10.0 Software. Descriptive statistics will be carried out on data collected to determine the frequency distribution of baseline characteristics of patients on ART with ICSRs. Logistic regression will also be conducted to identify the risk factors associated with the reported ADRs. The association between reported ADRs and specific variables such as patients’ age, sex and ART regimens will be assessed at 95% confidence interval. P values of 0.05 or less will be considered as statistically significant.
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