Profiling adverse reactions to novel drug-resistant tuberculosis regimens containing bedaquiline and linezolid

Objectives Tuberculosis (TB) poses a major global health concern, with drug-resistant strains posing significant treatment challenges. Drug-resistant TB (DR-TB) requires second-line anti-TB drugs, which often have severe side effects. This study focuses on evaluating adverse drug reactions (ADRs) in DR-TB patients to improve treatment outcomes by timely identification and management. Material and Methods This was a 2-year prospective observational descriptive study of 145 registered DR-TB patients initiated on treatment, among whom 79 developed ADRs. Demographic, clinical, and treatment data were collected from all 79 DR-TB patients. ADRs were assessed using statistical methods to determine any associations with factors such as age, sex, HIV status, and treatment regimen. Results The mean age of the study population having ADR was 38.5 years, with 67.0% male. Most patients (78.4%) were underweight, 77.2% were anemic, and 29.1% had comorbidities, mainly hypertension. About 74.6% of patients had a previous history of anti-TB treatment. Rifampicin (R)-mono resistance (64.5%) was the predominant resistance pattern. The overall ADR incidence was 54.5%, with peripheral neuropathy being the most frequent ADR (41.3%). Linezolid was the most commonly implicated drug, responsible for 58.6% of ADRs. Conclusion The study found a high incidence (54.5%) of ADRs in DR-TB patients, particularly peripheral neuropathy and anemia linked to linezolid. There were no significant associations between ADR occurrence and factors like age, sex, or HIV status. Vigilant monitoring and early intervention are critical for managing ADRs and improving treatment adherence among these patients.