Efficacy and safety of chemotherapy regimens with bedaquiline in patients with respiratory tuberculosis: Immediate and final results

Abstract

The objective of the study: to determine the efficacy and safety of chemotherapy regimens with bedaquiline in patients with respiratory tuberculosis in the context of everyday clinical practice with minimal non-inclusion criteria. Subjects and methods. In a prospective, open-label, non-randomized, single-center trial which included 315 patients, the efficacy and safety of chemotherapy regimens were evaluated, when prescribing a regimen the priority was given to bedaquiline, linezolid, levofloxacin/moxifloxacin, and cycloserine/terizidone. Patients were followed up for at least 24 months, 52.4% suffered from extensive drug resistance of M. tuberculosis (MTB), the majority of patients (50.8%) had a failure of the previous course of treatment, and serious co-morbidities were found in 89.5% of patients. Results. In 104 patients, the duration of treatment with bedaquiline was limited to standard 24 weeks, in 42 patients, it lasted for 36 weeks, in 56 patients - 48 weeks, and 94 patients received bedaquiline for more than 48 weeks. The increased duration of treatment with bedaquiline for more than 24 weeks provided a significant increase of treatment efficacy (regardless of drug resistance profile) from 66.2% (95% CI 54.4-77.9%) to 84.3% (95% CI 80.0-89.7%). The used regimens were well tolerated: serious adverse events (AE) were observed only in 27.6% of patients, and bedaquiline contribution to their development was not significant (bedaquiline had to be discontinued due to AE in 2.2% of cases). The range of AE practically did not differ from that when using only traditional anti-tuberculosis drugs.