Adverse Drug Reactions Related to Treatment of Drug-Susceptible Tuberculosis in Brazil: A Prospective Cohort Study

Flávia M Sant´Anna,Valeria C Rolla,Carolina A S Schmaltz,Mariana Araújo-Pereira,Bruno B Andrade,Raquel V C De Oliveira,María B Arriaga

doi:10.3389/fitd.2021.748310

Abstract

Standard anti-tuberculosis treatment is highly effective, but a great challenge is the management of adverse drug reactions (ADR). Our study aimed to characterize ADR according to type, severity and time of occurrence. A prospective tuberculosis (TB) cohort has been followed, from 2010 to 2016, at a reference center in Rio de Janeiro, Brazil. Clinical and laboratory tests information were collected in all visits. ADR were described according to the affected organ/system, classified as clinical and/or laboratory, early (first 2 months) or late. ADR’s causality and intensity were assessed. In our study 552 patients were included, 78.8% presented at least one ADR, 34% were people living with HIV (PLHIV). Most ADR were clinical (53%), early (82.5%), mild/moderate (88.7%) events and of “metabolic annutritional disorders” category. There were no significant differences in type, severity or causality between “early” and “late” groups. However, “early” group presented a higher frequency of “metabolic and nutritional disorders” (27.8%) and “gastrointestinal system disorders” (23.5%), while “skin and appendages disorders” were more frequent in the “late” group. ADR are frequent and occur at any time during treatment, although the majority are early and grade and not severe.

Highlights

The World Health Organization (WHO) estimates that by 2019, 10 million people worldwide were infected with Mycobacterium tuberculosis and 1.4 million people died of tuberculosis (TB) [1]
While examining adverse drug reactions (ADR) according to the time of onset, we found that there were no significant differences in type of event, severity, or relation with TB drugs between early versus late ADR
After grouping the ADR events according to the WHO-Antiretroviral therapy (ART) classification, it was possible to observe that the most frequent categories were “metabolic and nutritional disorders”, “gastrointestinal system disorders” and “skin and appendages disorders”, all initiating throughout the early phase (Figure 4A)

Summary

INTRODUCTION

The World Health Organization (WHO) estimates that by 2019, 10 million people worldwide were infected with Mycobacterium tuberculosis and 1.4 million people died of tuberculosis (TB) [1]. Standard anti-TB treatment (ATT) is highly effective and one of the great challenges for ATT success is management of TB drugs toxicity This toxicity is manifested through adverse drug reactions (ADR) [3]. ADR can range from mild to severe [4], can occur early or late in the course of ATT and are associated with unfavorable TB outcomes; if not detected quickly may be associated with high morbidity [5]. These events can result in treatment interruption, replacement of the associated drug and sometimes prolonged treatment length, hospitalization, low adherence and increased risk of resistance [6]. Our study aimed to characterize adverse events according to type, severity, causality, and time of occurrence in a population prospectively followed at a reference center for tuberculosis in Rio de Janeiro, a region with high burden of TB in Brazil

Ethics Statement

Study Design

RESULTS

DISCUSSION

ETHICS STATEMENT