Sekar Natarajan1, Rupak Singla2, Neeta Singla3, Amitesh Gupta1, Jose A Caminero4, Amartya Chakraborty1, Vikas Kumar1. 1. Department of Tuberculosis and Chest Diseases, National Institute of Tuberculosis and Respiratory Diseases, New Delhi 110030, India. 2. Department of Tuberculosis and Chest Diseases, National Institute of Tuberculosis and Respiratory Diseases, New Delhi 110030, India. Electronic address: drrupaksingla@yahoo.com. 3. Department of Epidemiology, National Institute of Tuberculosis and Respiratory Diseases, New Delhi 110030, India. 4. University Hospital of Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Spain.
Abstract
BACKGROUND: The study aimed to analyze frequency and severity of adverse events (AEs) and other reasons for interruption of treatment and loss to follow up (LTFU) during first six months of treatment among tuberculosis patients on bedaquiline containing regimens. METHODS: This pilot exploratory observational study included 275 patients enrolled consecutively over two years who received bedaquiline containing regimen under programmatic conditions in India. RESULTS: Among 275 patients with median age of 25 years, 86 (31.3%) patients had at least one interruption with 122 total episodes of interruption. Among these 70 were temporary, 35 were permanent interruptions and 17 were LTFU. The AEs due to drugs were the commonest reason for interruption observed in 81.4% of temporary interruption group and 97.1% of permanent interruption group. Among a total 192 adverse event episodes, (49.5%) were minor (grade 1-2) and (50.5%) were serious (grade 3-5). Personal factors were the commonest reason for interruption observed in LTFU (94.1%) group. The most common temporarily interrupted drug was bedaquiline in 8.7% and permanently stopped drug was linezolid in 5% of patients. CONCLUSIONS: Our study observed that drug related AEs are important risk factors associated with treatment interruptions in bedaquiline containing regimens. Bedaquiline is the most common temporarily interrupted drug due to AEs.
BACKGROUND: The study aimed to analyze frequency and severity of adverse events (AEs) and other reasons for interruption of treatment and loss to follow up (LTFU) during first six months of treatment among tuberculosis patients on bedaquiline containing regimens. METHODS: This pilot exploratory observational study included 275 patients enrolled consecutively over two years who received bedaquiline containing regimen under programmatic conditions in India. RESULTS: Among 275 patients with median age of 25 years, 86 (31.3%) patients had at least one interruption with 122 total episodes of interruption. Among these 70 were temporary, 35 were permanent interruptions and 17 were LTFU. The AEs due to drugs were the commonest reason for interruption observed in 81.4% of temporary interruption group and 97.1% of permanent interruption group. Among a total 192 adverse event episodes, (49.5%) were minor (grade 1-2) and (50.5%) were serious (grade 3-5). Personal factors were the commonest reason for interruption observed in LTFU (94.1%) group. The most common temporarily interrupted drug was bedaquiline in 8.7% and permanently stopped drug was linezolid in 5% of patients. CONCLUSIONS: Our study observed that drug related AEs are important risk factors associated with treatment interruptions in bedaquiline containing regimens. Bedaquiline is the most common temporarily interrupted drug due to AEs.
Authors: Simon E Koele; Stijn W van Beek; Gary Maartens; James C M Brust; Elin M Svensson Journal: Antimicrob Agents Chemother Date: 2022-01-10 Impact factor: 5.938