TITLE:
Interim Outcomes and Adverse Events among Drug-Resistant Tuberculosis Patients Treated with Bedaquiline in the Philippines
AUTHORS:
Vivian S. Lofranco, Maria Rhoda A. Torres-Cervas, Katherine A. Asence, Khrizza Marianne A. Del Mundo, Vincent M. Balanag, Mary Rosary T. Santiago, Anna Marie Celina G. Garfin
KEYWORDS:
Operational Research, New Anti-TB Drug Regimen Drug, Interim Outcomes, Adverse Events
JOURNAL NAME:
Journal of Tuberculosis Research,
Vol.10 No.2,
April
24,
2022
ABSTRACT: Objectives: This study
aimed to assess the interim outcomes for drug-resistant tuberculosis (DR-TB) patients treated with bedaquiline regimen under the
operational research conditions compared to DR-TB patients treated without
bedaquiline in their regimen, and to describe the adverse events that occurred
among patients treated with bedaquiline in the Philippines. Design: Patients who were treated with a bedaquiline-containing regimen from
June 2016 to May 2017 were included in this study as the intervention group,
while patients who were treated without bedaquiline regimen from January 2013
to May 2016 were included as the comparison group. The interim treatment
outcomes were compared using Chi-square test. The analysis of time to culture
conversion within 6 months of treatment was conducted. A Cox proportional
hazard model was constructed to identify the variables associated with a
favorable interim treatment outcome. The R program was used for statistical
analysis. Results: On the 6th month of treatment, the culture conversion for patients
treated with a bedaquiline-containing regimen was significantly higher than
with the comparison group [63/75 (84.0%) vs 84/117 (71.8%), p = 0.012)]. Nearly
15% of the patients treated with bedaquiline were lost to follow-up. Frequent
adverse events included vomiting, dizziness, nausea, joint pain, and abdominal
pain. Conclusion: The patients who were
treated with bedaquiline-containing regimen have better interim treatment
outcomes than those treated without bedaquiline, but the proportion of patients
who were lost to follow-up remains substantial.