Tolerability and Efficacy of Chemotherapy Containing Bedaquiline in Patients with Multiple Drug Resistant Pulmonary Tuberculosis

Abstract

The objective: to evaluate safety and efficacy of bedaquiline in the treatment of patients with multiple drug resistant tuberculosis (MDR-TB).Subjects and Methods. Clinical data of 523 patients above 18 years old registered for MDR TB treatment as per regimen 4 were retrospectively analyzed. HIV-negative patients were selected and divided into two groups by the use of bedaquiline in the chemotherapy regimen.Results. In MDR TB treatment regimen containing bedaquiline, adverse reactions were observed in 95.7% of cases, the majority of them (65.2%) were of mild or moderate degree of severity. In 30.4% of such cases, bedaquiline was temporarily discontinued (mostly due to hepatotoxic reactions). No cardiotoxicity was observed as a response to bedaquiline, the median corrected QT interval made 413 ms, the maximum value was 438 ms. Adding bedaquiline to the regimen resulted in faster (in the first 3 months of treatment) and more frequent (in 94.7%) sputum conversion by culture (in the regimens with no bedaquiline, it was achieved in 63.8% of cases, p = 0.019). Treatment with regimens containing bedaquiline was effective in 82.61% of patients, while regimens with no bedaquiline were effective in 65.2% of cases, p = 0.085.