Abstract

Background: Extensively drug-resistant tuberculosis (XDR TB) is a type of tuberculosis (TB) characterized by resistance to isoniazid and rifampicin, along with resistance to one of the fluoroquinolones and at least one of the second line injectable drugs. Bedaquiline is a diarylquinoline antimycobacterial agent approved for the treatment of adults with pulmonary multidrug-resistant TB (MDR-TB) and XDR-TB by the food and drug administration.

Aim and Objective: The aim of this study was to study the side effect profile of bedaquiline containing regimen among XDR TB patients.

Materials and Methods: This study was conducted at outpatient and wards of nodal drug-resistant TB Center, Department of Pulmonary Medicine, SVRRGGH, Tirupati, for a period of 1 year. Forty patients of more than 18 years age and diagnosed with XDR TB were included in the study. Bedaquiline was started and daily monitoring was done with ECG and all organ function tests were repeated every 15 days.

Results: All 40 cases were retreatment cases; no new XDR TB case was reported in study period. Most common age group of presentation in our study was 46 to 55 years (32.5%). Gastrointestinal adverse drug reactions were found to be more common (37.5%), cardiovascular QTc changes were observed in 10% of patients, 5% of patients had neurological reactions (Headache), 2.5% of patients had peripheral neuropathy, and 2.5% of patients had arthralgia.

Conclusions: Bedaquiline containing regimen is very effective for the treatment of XDR TB cases. The study shows that compliance with this regimen is very good. Bedaquiline has minimal adverse reactions and even these are easily manageable. Bedaquiline has good safety profile and patients have improved quality of life.

Key words: Extensively Drug-Resistant Tuberculosis; Bedaquiline; Side Effects; Nodal Drug-resistant TB Center