Abstract Background The regimen bedaquiline, pretomanid, and linezolid (BPaL), with or without moxifloxacin, is recommended for treating multidrug-resistant TB (MDR TB). We describe real-world outcomes and tolerability of BPaL, with or without fluroquinolone (BPaL-FQ) in the U.S. Methods Using data collected by the California MDR TB Service for patients receiving BPaL and BPaL-FQ during 2020–2024, we analyzed favorable outcomes (cure or treatment completion), relapse, and adverse event frequency and severity. Results Ninety-seven patients were started on any pretomanid-containing regimen during 2020-2024; 76 (78%) of these had pulmonary TB, 21 (22%) had concurrent or exclusive extra-pulmonary disease. Sixty-nine patients received at least four weeks of BPaL or BPaL-FQ and had final outcome documented. Favorable treatment outcomes were reported in 64 (93%) patients overall and in more than 80% of patients in almost all subgroups, irrespective of underlying resistance pattern, site of disease, or co-morbidities. There were no microbiologically-confirmed TB relapses. Two deaths occurred in patients receiving BPaL-FQ. Adverse events that led to a drug change occurred in 40% of patients and included peripheral neuropathy, cytopenias, gastrointestinal upset, and headache or dizziness. The majority were attributed to linezolid 600 milligrams daily and associated with linezolid trough above two micrograms per milliliter; fluroquinolones were also frequently implicated. Discussion In a cohort of patients receiving BPaL or BPaL-FQ in California during 2020-2024, a majority had a favorable outcome. More than a third of patients required drug dosage change or discontinuation to complete therapy. Linezolid was the main driver of poor tolerability and regimen changes.
Katrak et al. (Wed,) studied this question.
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