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

Abstract

Oral delamanid (Deltyba Ò ) 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 Mycobacterium tuberculosis. 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 C6 to 8 months was associated with higher rates of favourable outcomes and lower rates of unfavourable outcomes than treatment for B2 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.Adis evaluation of delamanid as part of appropriate combination regimen in multidrug-resistant tuberculosis Improves sputum culture conversion rates when added to optimal background regimens Treatment for C6 to 8 months provides higher rates of favourable outcomes and lower rates of unfavourable outcomes (including mortality) than treatment for B2 months Not associated with clinically relevant pharmacokinetic drug interactions Generally well tolerated Associated with an increased risk of QT interval prolongation (use requires caution in at-risk patient populations)