Evaluation of Safety of 9- and 6-Month Treatment Regimens in Patients with Rifampicin-Resistant Tuberculosis in the Republic of Belarus

Abstract

The objective: to evaluate the safety of 39- and 24-week treatment regimens in the patients with rifampicin-resistant tuberculosis (RR-TB).

Subjects and Methods. Cohorts of patients with RR-TB were treated with the following regimens: 550 patients received modified short course treatment regimens (mSCT), and 139 patients were treated with BPaLM regimen. Serious adverse events (SAEs) and adverse events of special interest (AESI) of grade 3 or higher were assessed according to the EndTB Severity Grading Scale, Version 5.

Results. In mSCT cohort, 113 SAEs were reported, in BPaLM cohort, 12 SAEs were reported, at least 1 SAE was reported in 16.0% and 7.2% of patients, respectively. In mSCT cohort, 37 AESI were reported in 5.8% of patients. Of the 150 SAEs/AESI reported in mSCT cohort, 78.7% have resolved, 4.0% are being resolved, 0.7% have resolved with sequelae, and 2.7% have not resolved. Of the 12 SAEs in BPaLM cohort, 66.7% have resolved, 16.7% are being resolved, and 8.3% have resolved with sequelae. Drugs were discontinued in 16.8% of SAEs, 8.1% of AESI in mSCT cohort, and 25.0% of SAEs in BPaLM cohort. In mSCT cohort, 21 patients died during treatment, only in 6 patients the influence of anti-tuberculosis drugs on the fatal outcome could not be ruled out, in 15 cases there was no such a correlation. In BPaLM cohort, 1 patient died due to progression of concomitant cancer.

Conclusions. SAEs/AESI rarely occur with mSCT and BPaLM regimens and rarely lead to treatment discontinuation. Appropriate monitoring and management of SAEs/AESI is an important component of clinical practice.