COMPARATIVE SAFETY AND TOLERABILITY OF THE SHORT-COURSE BPaLM REGIMEN VERSUS CONVENTIONAL THERAPY FOR MDR-TB: A RETROSPECTIVE COHORT STUDY FROM A TERTIARY PULMONOLOGY HOSPITAL IN ROMANIA
ANTONELA DRAGOMIR 1,2,3, BEATRICE MAHLER 1,2,3, SILVIU VLĂSCEANU 5,3, ANCA FÂCĂ 3,6, EMILIA HOMEA 3, TEODORA MELINTE 3, DRAGOȘ BĂICEANU 4, TRAIAN PANCIU 4, ELMIRA IBRAIM 4, ALEXANDRU STOICHIȚĂ 1,2,3,4*
1 Pneumology II Department, Faculty of Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
2 Pneumology Clinic, “Marius Nasta” Institute of Pneumology, Bucharest, Romania
3 Faculty of Medicine, “Marius Nasta” University of Medicine and Pharmacy, Bucharest, Romania
4 Research Department, “Marius Nasta” Institute of Pneumology, Bucharest, Romania
5 Thoracic Surgery Department, “Marius Nasta” Institute of Pneumology, Bucharest, Romania
6 Clinical Pharmacy Department, “Marius Nasta” Institute of Pneumology, Bucharest, Romania
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Multidrug-resistant tuberculosis (MDR-TB) continues to represent a major public health concern in Romania, where treatment outcomes are often compromised by drug-related toxicity and poor adherence. This study aimed to evaluate the safety and tolerability of the six-month, all-oral BPaLM regimen (bedaquiline, pretomanid, linezolid, moxifloxacin) in comparison with conventional 18 - 20-month MDR-TB regimens, while incorporating demographic risk profiling. We conducted a retrospective cohort study at the Marius Nasta Institute, Bucharest, including 46 patients treated between January and September 2024. Patients received either the standardized BPaLM regimen or individualised long-course therapy. Clinical monitoring comprised electrocardiography, laboratory analyses, sputum cultures and chest radiographs. The primary endpoint was the incidence and severity of adverse events. Adverse event rates were similar between BPaLM and long-course regimens, although age-related patterns were observed within each treatment group. Smoking exposure was not associated with adverse outcomes, and multivariable analysis did not identify independent predictors after adjusting for age, sex, smoking status and treatment regimen. Overall, BPaLM demonstrated a comparable safety profile with improved tolerability in younger adults.
