Antiretroviral Induced Adverse Drug Reactions in Hiv Infected Patients in Mali: A Resource-Limited Setting

Background: To our knowledge, there is a rare report regarding antiretroviral induced adverse drug reactions (ADRs) in Malian patients who were infected with the human immunodeficiency virus (HIV). We have evaluated the frequency of antiretroviral therapy (ART) induced ADRs in this population and have assessed some risk factors of these reactions. Methods & Materials: This is a prospective cohort study that was performed in the Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome Research Center (The CESAC) of Mali during years 2010–2011. Adults patients, who were infected with HIV and newly started on ART, were included in this study and by laboratory and clinical follow-up was performed for at least 6 months to detect the occurrence of any ADR. Naranjo's scale of classification has been used to characterize the side effects. Results: During this study 94.6% of patients showed at least one ADR and 5.3% at least two ADRs. Prevalence of ADRs based on affected organ was 3.1% gastrointestinal (GI), 15.4% hematological, 45.9% neurological, 10.6% cutaneous, 1.4% hepatic, and 20.4% metabolic adverse effects. Adverse events were highly probable according to the Naranjo score (83.7%).The use of Zidovudine and Stavudine was observed as risk factors for anaemia, and peripheral neuropathy,and lipodystrophy, respectively, while nevirapine and female gender were identified as risk factors for skin reactions, lipohypertrophy by bivariate logistic regression. Conclusion: Side effects were frequently encountered in our study. The nature of these adverse events was mostly peripheral neuropathy, lipoatrophy, lipodystrophy, and anemia. The link between the use of antiretroviral drugs and adverse events was highly probable according to the Naranjo probability scale. We recommend an active clinical and laboratory monitoring of antiretroviral therapy to strengthen pharmacovigilance in Mali.