ABSTRACT: Multidrug-resistant and extensively drug-resistant tuberculosis (TB) are associated
with worse treatment outcomes for patients, including higher mortality, than for drug-sensitive
tuberculosis. Delamanid (OPC-67683) is a novel anti-TB medication with demonstrated activity
against multidrug-resistant disease.
Patients who participated in the previously reported randomised, placebo-controlled trial of
delamanid and the subsequent open-label extension trial were eligible to participate in a 24-month
observational study designed to capture treatment outcomes. Treatment outcomes, as assessed
by clinicians and defined by the World Health Organization, were categorised as favourable and
unfavourable. Delamanid treatment groups were combined for analysis, based on their duration of
treatment. In total, for 421 (87.5%) out of 481 patients from the original randomised controlled trial,
consent was granted for follow-up assessments.
Favourable outcomes were observed in 143 (74.5%) out of 192 patients who received delamanid
for o6 months, compared to 126 (55%) out of 229 patients who received delamanid for
f2 months. Mortality was reduced to 1.0% among those receiving long-term delamanid versus
short-term/no delamanid (8.3%; p,0.001). Treatment benefit was also seen among patients with
extensively drug-resistant TB.
This analysis suggests that treatment with delamanid for 6 months in combination with an
optimised background regimen can improve outcomes and reduce mortality among patients with
both multidrug-resistant and extensively drug-resistant TB.