Adverse Drug Reactions to Antiretroviral Therapy: Frequency, Type, and Risk Factors in Children in Mali.

Objective: The aim of our study was to evaluate the frequency, type, and risk factors associated with adverse drug reactions (ADRs) in HIV-positive children with adherence to antiretroviral therapy (ART) at the Unit of Care and Accompaniment for People Living With HIV (USAC) of Bamako.

Methods: A cross-sectional study was conducted at USAC of Bamako from May 1, 2014, to July 31, 2015. We included children aged 1 to 14 years with at least 6 months of ARV treatment initiated at USAC, with or without ADRs. Data collection was based on information collected from parents and clinical/biological assessments.

Results: Median age of participants was 36 months and female sex was predominant (54.8%). Poor adherence during the study was observed in 15% of cases. Of patients in the study, 52% had a CD4 count less than 350 cells/mm³ at the time of adverse events. In bivariate analysis, we found that participants with adherence to ART tended to be younger than those with non-adherence to ART (36 vs 72 months, p = 0.093). In multivariable analysis, prophylactic treatment was the only factor marginally associated with ART adherence in HIV patients (p = 0.09). No other adverse biological effects or clinical conditions were associated with ART adherence in this study.

Conclusions: In this study we found that ADRs were frequent in HIV-positive patients but less frequent in ART-adherent HIV-positive children. Therefore, it is essential to regularly monitor children receiving ARVs to detect and treat the complications associated with these therapies according to ART adherence.