Overview on adverse effects of bedaquiline containing regimens for drug resistant tuberculosis

Abstract

Bedaquiline (BDQ), first approved by the US Food and Drug Administration in 2012, has become a fundamental drug in all oral regimens for the treatment of drug-resistant tuberculosis (DR-TB) due to its ability to inhibit the proton pump of mycobacterial ATP synthase, disrupting energy production in Mycobacterium tuberculosis . The aim of this review is to evaluate and summarize current studies on the adverse effects of BDQ-containing regimens for DR-TB, with a focus on identifying the most frequently reported adverse drug reactions (ADRs). A comprehensive literature search was conducted using databases such as PubMed and Google Scholar with keywords including “Bedaquiline,” “adverse drug reactions,” and “drug-resistant tuberculosis,” yielding 44 studies, of which 34 were included in the final analysis. Data were extracted and thematically organized based on reported adverse events. The most common ADR identified was QT prolongation, affecting 17.5% of patients, followed by hepatotoxicity (13.2%), peripheral neuropathy (9.5%), arthralgia (7.3%), and ototoxicity (6.7%), highlighting the need for vigilant monitoring during BDQ treatment. While BDQ plays a crucial role in DR-TB management, its association with significant ADRs necessitates careful patient monitoring, particularly through regular ECG assessments. Future research should focus on optimizing treatment protocols to improve the safety and efficacy of BDQ regimens in DR-TB therapy.