TITLE:
The Introduction of Bedaquiline Regimen for Drug-Resistant Tuberculosis in the Philippines: An Operational Study
AUTHORS:
Vincent M. Balanag Jr., Vivian S. Lofranco, Mariquita J. Mantala, Mary Rosary T. Santiago, Patrice Jamie E. Cabasis, Arnyl G. Araneta, Anna Marie Celina G. Garfin
KEYWORDS:
Bedaquiline, Drug-Resistant TB, XDR-TB
JOURNAL NAME:
Journal of Tuberculosis Research,
Vol.10 No.4,
December
9,
2022
ABSTRACT: Objectives: Bedaquiline (BDQ) is the first new anti-tuberculosis (TB) drug
introduced to the market after 45 years. Recent studies have shown the
potential benefits of adding bedaquiline to regimens for drug-resistant TB
(DR-TB). In search of more effective regimens for DR-TB, bedaquiline was
introduced in the TB program in the Philippines under operational research to
assess its effectiveness, safety, and tolerability when given with background
regimens among patients with multi-or extensively DR-TB (MDR/XDR-TB). Design: A prospective cohort study of patients with MDR/XDR-TB was given with a
bedaquiline-containing regimen from June 2016 to May 2017. Demographic data,
presence of comorbidities, and microbiologic profile on entry were recorded.
Bedaquiline was administered at the recommended dose of 400 mg once daily for
14 days, then 200 mg three times a week for 22 weeks together with World Health
Organization (WHO)-compliant background regimen. The time to culture
conversion, interim outcomes at the 6th month of treatment, end-of-treatment
outcomes, and post-treatment follow-up outcomes after one year was determined.
The frequency and severity of adverse events (SAE) were recorded as part of
pharmacovigilance. Results: Seventy-five patients were given with
bedaquiline-containing regimen during the study period. Forty-two (56.0%) had
second-line injectable resistance, 23 (30.7%) had fluoroquinolone-resistance, 6
(8.0%) had MDR-TB, and 4 (5.3%) had XDR-TB. In the 6th month of post-enrolment, 79% were
culture-negative. The treatment success rate was 65.3% (37 were
cured and 12 completed treatment), 7 (9.3%) died, 17 (22.7%) lost to follow-up,
and 2 (2.7%) were withdrawn from treatment. Adverse events included vomiting
(80%), dizziness (69%), nausea (52%), cough (44%), and headache (36%). The
post-treatment follow-up of 49 patients in the 12th month showed 92% were
culture-negative while 8% of TBC were not done. Conclusion:
Bedaquiline-containing regimens for patients with MDR/XDR-TB were highly
effective with an acceptable safety profile and favorable treatment outcomes,
but the proportion of patients who lost to follow-up remains substantial.