Delamanid Improves Outcomes and Reduces Mortality for Multidrug-Resistant Tuberculosis

Abstract

Multidrug-resistant and extensively drug-resistant tuberculosis are associated with worse treatment outcomes for patients, including higher mortality, than for drug sensitive tuberculosis. Delamanid (OPC-67683) is a novel anti-tuberculosis 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 categorized as favourable and unfavourable outcomes. Delamanid treatment groups were combined for analysis, based on their duration of treatment. In all, 421/481 patients (87.5%) from the original randomised, controlled trial were followed and assessed.

Favourable outcomes were observed in 143/192 patients (74.5%) who received delamanid ≥6 months, compared to 126/229 patients (55.0%) who received delamanid for ≤2 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 disease.

This analysis suggests that treatment with delamanid for 6 months in combination with an optimized background regimen can improve outcomes and reduce mortality among patients with both multidrug-resistant and extensively drug-resistant tuberculosis.