TITLE:
Effectiveness and Safety of 9-Month Treatment Regimen for Multidrug-Resistant Tuberculosis in the Philippines
AUTHORS:
Vivian S. Lofranco, Vincent M. Balanag Jr, Lawrence O. Raymond, Noel G. Macalalad, Alex Golubkov, Mary Rosary T. Santiago, Anna Marie Celina G. Garfin
KEYWORDS:
MDR-TB, Short Treatment Regimen, Treatment Outcomes, Prospective Studies
JOURNAL NAME:
Journal of Tuberculosis Research,
Vol.10 No.2,
June
29,
2022
ABSTRACT: Background: The Philippines has a burden of drug-resistant tuberculosis
(DR-TB). One of the key challenges in the programmatic management of DR-TB
(PMDT) is the high rate of loss to follow-up (38% in the 2010 cohort). An
urgent need for a shorter, more tolerable, less expensive treatment regimen
exists. The aim of the operational study is to determine the efficacy and
safety of the short treatment regimen among drug resistant TB. Methods: This is a prospective single-arm cohort study evaluating the effectiveness
and safety of a shorter 9 - 11-month treatment regimen (9MTR) for rifampicin-resistant/multi-drug
resistant TB (RR/MDR-TB) in 10 PMDT facilities. All eligible consenting adult patients with rifampicin-resistant TB were enrolled and received the standardized 9-month treatment regimen (9MTR),
including injectables, with a follow-up after 12 months of treatment
completion. Results: A total of 329 patients were enrolled from July 2015 to December 2016.
At the 6th month post-enrollment, 256 (77.8%) of them had culture-negative test
results. The end-of-treatment success rate was 74.1% (224 [68.0%] were cured
and 20 [6.1%] completed the treatment). On the other hand, 10 (3.0%) died, 41
(12.5%) lost to follow-up, 33 (10.0%) withdrawn, 1 (0.3%) treatment failure. In
the 12th month after 9MTR completion, among the 244 patients with successful
treatment, 198 (81.1%) had culture-negative results, while there were 46
patients whose culture tests were not done. One patient developed TB relapse
with fluoroquinolone resistance. The majority of the adverse events were mild
that occurred mostly during the first 6 months of treatment. Conclusion: The 9-month treatment regimen had a high treatment success rate with a
favorable safety profile. The loss to follow-up was reduced; however, it was
still a challenge. The introduction of the 9MTR via operational research had a
major impact on building national capacity and infrastructure for the
programmatic adoption of a new regimen. Ten
PMDT centers received training and experience, created diagnostic pathways,
and active drug safety monitoring and management were built.