A prospective cohort study of patients with drug-resistant tuberculosis (TB) in Belarus and Uzbekistan found that the 6-month, all-oral treatment regimens recommended by the World Health Organization (WHO) were safe and highly effective, researchers reported this week in Clinical Infectious Diseases.
The study, led by researchers with Medecins San Frontieres, analyzed data on adult patients with microbiologically confirmed multidrug-resistant or rifampicin-resistant (MDR/RR)-TB and pre-extensively drug-resistant (pre–XDR)-TB who received treatment with one of two BPaL (bedaquiline, pretomanid, and linezolid)-based regimens from February 2022 to June 2023. The aim of the trial was to assess the performance of BPaL-based regimens in non-clinical trial settings that have a high burden of drug-resistant TB.
While the regimens have demonstrated treatment success rates of 90% or higher in clinical trials and were recommended by the WHO in 2022, data from real-world settings are lacking.
Findings support WHO recommendation
Of the 667 patients enrolled in the study, 440 (65%) had MDR/RR-TB and 237 (35%) had pre–XDR-TB. MDR/RR-TB patients were treated with BPaL plus moxifloxacin, and pre–XDR-TB patients received BPaL plus clofazimine. Overall, 93.6% of patients had a successful treatment outcome: 95.3% of MDR/RR-TB patients and 90.4% of pre–XDR-TB patients. Sixty-nine of 667 patients (10.2%) experienced serious adverse events during treatment, including 24 deaths (3.5%), 11 of which occurred during treatment. Of the 24 deaths, 20 (83.3%) were not related to TB or TB treatment.
Among the 383 patients who were successfully treated and completed 12-month follow-up, 2 (0.5%) experienced TB recurrence.
The study authors note that the treatment success rates are comparable to results from multiple phase 3 clinical trials for BPaL-based regimens, including the TB-PRACTECAL, Nix-TB, and ZeNix trials.
“Overall, our results contribute important real-world evidence on the effectiveness of BPaL-based regimens, lending support to the new WHO guidance recommending their global implementation,” they wrote. They added that further research is needed in other key populations, including children and people with severe forms of extrapulmonary TB.
Chris Dall, MA
For more TB updates, check out the TB CAB Weekly Newsletter (Issue #7, 23 February 2025).
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