Delamanid in multidrug-resistant tuberculosis: a guide to its use in the EU

Abstract

Oral delamanid (Deltyba^®) is a useful addition to the treatment options currently available to treat patients with multidrug-resistant tuberculosis (MDR-TB). In the EU, it is indicated for use as part of an appropriate combination regimen in adults with MDR-TB when an effective treatment regimen cannot otherwise be composed due to resistance or tolerability. It exhibits potent antitubercular activity against drug-susceptible and -resistant strains of Mycobacteriumtuberculosis. In a 3-month randomized control trial (2 months treatment + 1 month follow-up) in adults with MDR-TB, delamanid 100 mg twice daily + an optimized background regimen (OBR) improved 2-month sputum culture conversion rates to a significantly greater extent than placebo + OBR. In consecutive extension and follow-up studies, treatment with delamanid for ≥6 to 8 months was associated with higher rates of favourable outcomes and lower rates of unfavourable outcomes than treatment for ≤2 months. Delamanid was generally well tolerated in patients with MDR-TB. To reduce the potential risk of QT interval prolongation with delamanid, recommendations regarding monitoring and precautionary measures should be followed.