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Risk factors, management and outcomes of adverse drug reactions in adult patients on antiretrovirals at Kenyatta National Hospital, Nairobi

L Mwangangi
R Juma
D Scott
D Nyamu
K Kuria


Background: Antiretrovirals have been associated with serious adverse drug reactions. Several factors have been suggested as independent risk factors for their development. Identification of these factors may help in prevention and management of the adverse drug reactions.
Objective: To describe the factors associated with adverse drug reactions, their management, and the clinical outcomes.
Design: A retrospective cohort study.
Setting: Kenyatta National Hospital, Comprehensive Care Centre.
Subjects: Adult patients receiving antiretrovirals from 2003 to 2006.
Main outcome measures: The primary outcomes were the risk-factors, interventions and outcomes of documented adverse drug reaction after exposure to antiretrovirals.
Results: Systematic random sampling was used to pick 350 patients’ files. The risk factors for experiencing at least one adverse drug reaction were: having a baseline CD4 count less than 123 (odds ratio [OR] = 1.82, 95% confidence interval [CI]: 1.18 to 2.79; p=0.006); treatment with antiretrovirals for more than 32 months (OR =1.76, CI: 1.15 to 2.71; p=0.010), using didanosine containing regimens (OR=3.7, CI: 1.40 to 9.70; p=0.008) or being on stavudine containing regimens (OR=4.4, CI: 2.53 to 7.71; p=0.001). The most common intervention was addition of a non-antiretroviral while 41% of events resulted in a change of anti-retroviral therapy.
Conclusions: Current standard regimens in resource-limited countries are associated with an increased risk of adverse drug reactions. Almost half of adverse reactions are managed by addition of a non-anti-retroviral drug alone but 41% necessitated a change of anti-retrovirals.