Setting: Bedaquiline (BDQ) was introduced in the multidrug-resistant tuberculosis (MDR-TB) programme in Daru
in remote Papua New Guinea in 2015, along with a core
package of active drug-safety monitoring (aDSM).
Objective: To assess interim results and safety of BDQ for
the treatment of MDR-TB from 1 July 2015 to 31 December 2017.
Design: A retrospective cohort analysis of routine programme data.
Results: Of 277 MDR-TB patients, 77 (39%) received
BDQ with a total of 8 serious adverse events including 5
(6.5%) deaths, of which 1 (1.3% QTcF prolongation,
grade 3) was attributable to BDQ. Of 200 (61%) patients
who did not receive BDQ, there were 17 (9%) deaths.
Completeness of monitoring for the BDQ group was
90% for 5 electrocardiograms and 79% for 2 cultures. In the interim result indicator analysis at month 6
in the BDQ and non-BDQ groups, there were respectively
0% and 1% lost to follow-up; 6.5% and 8.5% who died;
94% and 91% in care; and 92% and 96% with negative
culture among those monitored.
Conclusion: Early experience in Daru shows BDQ is safe
and feasible to implement with aDSM with good interim
effectiveness supporting the rapid adoption and scale-up
of the 2019 WHO MDR-TB treatment guidelines in the
programme and in similar remote settings.
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