Journal of Pharmacovigilance

Abstract

Adverse Drug Reactions to Antiretroviral Therapy (ART): Prospective Study in HIV Infected Adults in Sikasso (Mali)

Aboubacar Alassane Oumar, Amadou Abdoulaye, Mamoudou Maiga, Younoussa Sidibé, Yacouba Cissoko, Issa Konaté, Maimouna Diarra, Fanta Sangho, Jean Paul Dembélé, Paul M Tulkens and Sounkalo Dao

Objective: The purpose of this study was to evaluate the adverse effects of Antiretroviral Therapy (ART) in adult HIV-infected patients in decentralized setting of Sikasso, in Mali. Methods: This is a proactive study that took place from 2 January 2011 to 30 December 2012 at the Hospital of Sikasso (Department of Medicine). HIV-infected adult patients who have started ART at least 3 months before were included in this study to monitor the laboratory and clinical Adverse Drug Reactions (ADR) for at least 6 months. The WHO classification of adverse drug reactions has been used to investigate the causality of antiretrovirals. Results: Women were the most represented with 58% of the cases. The most represented age range was 26-47 years with 73.6%. Of the 178 patients enrolled, 61.2% had an ADR. ADR were neurological (40.4%), digestive (35.8%), cutaneous (18.3%) and hematological (5.5%). Stavudine was the most incriminated molecule, in 24.8% of the cases. The WHO grade 4 classification of ART toxicity was represented in 3.4% of the cases. The WHO causality score of “certain” was found in 29.8% of the cases. Conclusion: Adverse effects of Antiretrovirals are frequent and could be life-threatening in short and long terms. Regular follow-up of patients receiving these triple therapies, and the associated complications, is essential. We recommend active surveillance of antiretroviral therapy to strengthen Pharmacovigilance in Mali.