Effectiveness and safety of bedaquiline, pretomanid, linezolid and moxifloxacin in drug-resistant tuberculosis patients in selected public hospitals in Ethiopia: a multicenter retrospective cohort study

Tuberculosis is a major public health problem, and its treatment has become challenging due to the emergence of drug-resistant tuberculosis. Since 2022, the World Health Organization has called for the rollout of the 6-month bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) for the treatment of drug-resistant tuberculosis, but its effectiveness and safety are yet to be known in Ethiopia. The aim of this study was to investigate the time to culture conversion, treatment outcomes, and safety of patients enrolled on BPaLM regimen in selected public hospitals in Ethiopia from September 2023 to July 2025. A facility-based, retrospective cohort study was conducted on patients with drug-resistant tuberculosis who were enrolled on BPaLM and three treatment initiating centers were chosen as the study area due to the high volume of patients. The selected centers were St. Peter Specialized Hospital, All-Africa Leprosy, Tuberculosis, and Rehabilitation Training Centre, Comprehensive Specialized Hospital, and Dilla University Referral Hospital. Records of the patients were reviewed from the beginning to the end of treatment. Information on socio-demographic and clinical characteristics was extracted from patients’ charts and registries from May 1st 2025 to July 30 2025. All 104 patients who received the BPaLM regimen in the selected treatment initiating centers were included in the study. Descriptive statistical methods were presented as frequencies and percentages for categorical variables, medians, and interquartile range for continuous variables. Time to culture conversion was summarized using Kaplan-Meier curves. A total of 98 (94%) of the patients had good treatment outcomes, 2(1.9%) were lost to follow up, and 3(2.9%) died. Culture conversion rates were 48% at 30 days, 78% at 60 days, and 93% at 90 days. Adverse events during treatment occurred in 16 (15%) and 5 (4.8%) experienced a serious adverse event that resulted in hospitalization. Gastrointestinal disturbance was the most common adverse event occurring in 16(15%), followed by visual disturbance 3 (2.9%), prolonged QT interval 2 (1.9%), and peripheral neuropathy 2 (1.9%). National Tuberculosis programs and hospitals should strengthen the adoption of the 6-month all oral BPaLM regimen for all eligible drug-resistant tuberculosis patients, given the high treatment success, rapid culture conversion, and manageable safety profile. Strong active drug safety monitoring should also be in place to closely monitor patients for adverse events, to anticipate and consequently decrease the rate of serious adverse events.