Treatment success rate and time to culture conversion under a prospective BPaL cohort study

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BACKGROUND: In July 2022, Indonesia implemented the 6-month BPaL (bedaquiline, pretomanid, linezolid) regimen under operational research (OR) for selected drug-resistant tuberculosis patients. The study aimed to assess treatment success rate (TSR) and time to sputum culture conversion (TSCC). METHODS: A prospective cohort study in fifteen sites between July 2022 and March 2023 enrolled patients with rifampicin-resistant/multidrug-resistant TB with additional fluoroquinolone resistance or intolerance/failures of previous second-line TB treatment. TSR was descriptively analysed, and Kaplan-Meier and Cox proportional-hazards analyses were used to evaluate TSCC. RESULTS: A total of 87 patients were enrolled, 3 were withdrawn, and 84 completed treatment and had outcomes; 82 (97.6%) patients had successful treatment, 1 (1.2%) died, and 1 (1.2%) had failure. Overall, 61 (72.6%) patients had positive cultures at baseline, and favourable outcomes were included in the TSCC analysis; all 61 (100%) converted within the first 3 months (median 32 days of treatment, IQR 30.0-56.0). None of the six variables were statistically associated with conversion time. CONCLUSION: The Indonesian BPaL OR showed a highly promising TSR of 97.6%, with 100% sputum conversion within 3 months. The lack of observed statistical differences in the TSCC across variables shows that the BPaL treatment will be equally effective in all patient groups.