Antiretroviral-induced adverse drug reactions in HIV-infected patients in Mali: a resource-limited setting experience

Aboubacar Alassane Oumar1*, Mamadou Dakouo2, Anicet Tchibozo2,
Mamoudou Maiga3, Guida Landouré4, Raysso Abdi-Bogoreh5,
Paul M. Tulkens6, Sounkalo Dao7, Jean Cyr Yombi8

1Department of HIV/TB Research & Training, HIV/TB Research & Training Center Bamako, USTTB
2Department of Public Health, Université de Montreal, Montreal, Canada
3Department of Global Health, Northwestern University, Chicago, USA
4Department of Neurology, Centre Hospital, University du Point «G», Bamako, Mali
5Department of Medicine, d’odontostomatologie, Bamako, Mali
6Department of Cellular & Molecular Pharmacology, Catholic University of Louvain, Brussels, Belgium
7Department of Infectious Diseases, Centre Hospital, University du Point «G», Bamako
8Department of Internal Medicine & Infectious Diseases, AIDS Reference Center, Catholic University of Louvain, Brussels, Belgium

International Journal of Basic & Clinical Pharmacology | May 2019 | Vol 8 | Issue 5 Page 831-836

ABSTRACT

Background: There are few reports in the literature from sub-Saharan Africa (SSA) regarding
antiretroviral-induced adverse drug reactions (ADRs). Antiretroviral therapy (ART) is now
widely available in SSA, and ADRs during HIV infection are also frequent. In this study, we
reported the frequency and risk factors of ART-induced ADRs in a Malian population.

Methods: This prospective cohort study was performed in the HIV Care and Counseling Centre
(CESAC) of Mali from 2011 to 2012. Adult patients infected with HIV and who had recently
started ART were included and followed-up clinically Were included in this study, adult
patients living with HIV and had recently started ART who were followed up for at least 6
months to determine the incidence of ADRs using Naranjo’s classification scale.

Results: During this study, 357 (42.3%) patients presented ADRs (40.1% of our patients (n=338)
experienced at least one ADR, and 2.2% (n=19) experienced at least two ADRs). The prevalence
of ADRs by organ system was: 45.9% neurological (n=164); 29.4% metabolic (blood chemistry)
(n=105); 15.4% hematological (n=55). High probable rate of ADR was observed as indicated by
the Naranjo score in 83.7% of the cases. Zidovudine (AZT) and stavudine (d4T) use was
identified as a risk factor for either anaemia or peripheral neuropathy whereas nevirapine
(NVP) and female gender were risk factors for skin reactions. Patients with advance disease
had the highest rate of ADRs compared to the others.

Conclusions: Based on the Naranjo probability scale, our data show that ADRs such as
peripheral neuropathy and anemia are very frequent. These ADR was linked to AZT and D4T. Our
findings highlight the need for active monitoring, continuous pharmacovigilance of ART and
change of some ART drug in this population.

Keywords: Antiretrovirals side effects, AZT, D4T, Mali, Proactive pharmacovigilance, Sub-Saharian Africa