Selection of BPaLM regimen in the treatment of rifampicin-resistant tuberculosis improved outcomes

Researchers compared the efficacy of standard therapy for rifampicin-resistant tuberculosis and a combination regimen of bedaquiline, pretomanid and linezolid combined with moxifloxacin. Combination therapy with four oral antituberculosis drugs was significantly more effective in preventing adverse outcomes.

An international team of scientists from University College London, the Republican Scientific and Practical Centre for Pulmonology and Tuberculosis in Minsk and the Republican Specialized Scientific and Practical Medical Centre for Phthisiology and Pulmonology in Tashkent, supported by Médecins Sans Frontières, conducted a comparative study of combination therapy with bedaquiline, pretomanid and linezolid (BPaL) combined with moxifloxacin (BPaLM) and standard therapy in a population of patients with rifampicin-resistant tuberculosis. The results of the study are published on Medscape portal.

Adverse outcome was recorded in 41% of the standard therapy group and 12% of the BPaLM group. Patients with equal efficacy and superior efficacy were significantly more in the BPaLM group.

Of the adverse outcome criteria, premature discontinuation of treatment was the most frequently reported, and was recorded in 89% of patients in the standard therapy group and 69% of patients in the BPaLM group. Adverse events were the reason for treatment discontinuation in 23% of patients in the standard therapy group and in 64% of patients in the BPaLM group.

However, adverse events of grade 3 and higher were observed in fewer BPaLM group patients (23% vs. 48%). The most frequent adverse events included adverse events from the liver, cardiovascular system and hematopoietic organs (anemia). Comparative analysis according to sex, age, disease severity, retreatment status and smoking status consistently showed a benefit of the BPaLM combination therapy regimen.

The TB-PRACTECAL trial enrolled 552 patients over 15 years of age with rifampicin-resistant tuberculosis. Participants were randomized to standard therapy or BPaLM combination therapy (bedaquiline, pretomanid, linezolid, and moxifloxacin). After 72 weeks, a composite adverse outcome score was assessed, which included death, treatment failure, treatment interruption, tuberculosis relapse, and patient failure to present for follow-up.

The authors believe that BPaL-based therapy regimens have the potential to improve outcomes for thousands of patients with rifampicin-resistant TB. These therapy options have several advantages over the 9- to 20-month regimens of standard treatment; they are shorter in duration, require fewer drugs, improve quality of life, and are cost-effective.