Adverse Events Associated with Multidrug-Resistant Tuberculosis Treatment in Mali

Événements indésirables associés au traitement de la tuberculose multirésistante au Mali

Abstract

Background: Adverse events induced by second-line anti-tuberculosis drugs severely impact adherence to treatment. In this study, we determined the incidence of adverse events and their impact on multidrug-resistant tuberculosis (MDR-TB) treatment at the department of Pneumo-phtisiology of the Teaching Hospital of Point-G, Bamako, Mali.

Methods: A prospective and descriptive cross-sectional study was conducted from January 2018 to August 2019 at the department of Pneumo-phtisiology of the Teaching Hospital of Point G. The study participants were all MDR-TB hospitalized patients and received a 9-months standardized shorter MDR-TB regimen. Adverse events were assessed based on clinical and laboratory outcomes criteria, and the assessment of ADR causality was performed using the World Health Organization (WHO)  algorithm.

Results: Adverse events were recorded in 86.2% (n=31) of patients, with an average age of 40 years old (ranging from 18 to 77 years). The most observed adverse events were digestive disorders, with 37.3%, followed by pain upon injection, with 19.3%. WHO grade IV toxicity of hearing loss (mixed or bilateral deafness) was observed in 3.62% (n=3) of participants. The causality of the WHO adverse events was "probable and possible" in 24.1% (n=20). Management of these adverse events consisted of counseling and antihistamine drugs prescription. The evolution was favorable in 42% of cases, however the fatality rate was 5.6%.

Conclusion: Various adverse events were observed in this study population. Therefore, special attention through pharmacovigilance is needed to improve the management of serious adverse events in this group of patients.

Keywords: Adverse events, MDR-TB, TB Treatment, second-line anti-tuberculosis drugs, Mali.