Delamanid in multidrug-resistant tuberculosis: a guide to its use in the EU
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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 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 ≥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.
KeywordsIsoniazid Moxifloxacin Capreomycin Successful Treatment Outcome Effective Treatment Regimen
The review was updated from Drugs 2015;75(1):91–100 , and was reviewed by: N. Cebotarenco, Coalition for Rational and Safe Use of Medicines (CoRSUM), Chişinău, Republic of Moldova; I. D. Olaru, Division of Clinical Infectious Diseases, Research Center Borstel, Borstel, Germany, S. Saluja, Saran Ashram Hospital, Dayalbagh, Agra, India; J-P. Zellweger, Swiss Lung Association, Berne, Switzerland. During the peer review process, the manufacturer of delamanid was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
Compliance with ethical standards
The preparation of this review was not supported by any external funding.
Conflicts of interest
K A. Lyseng-Williamson, H. A. Blair and L. J. Scott are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.
- 2.Global tuberculosis report 2014. Geneva: World Health Organization; 2014.Google Scholar
- 7.Deltyba (delamanid) 50 mg film-coated tablets: summary of product characteristics. London: European Medicines Agency; 2014.Google Scholar
- 8.Deltyba (delamanid): public assessment report. London: European Medicines Agency; 2014.Google Scholar
- 18.The use of delamanid in the treatment of multidrug-resistant tuberculosis: interim policy guidance. Geneva: World Health Organization; 2014.Google Scholar
- 21.US National Institutes of Health. ClinicalTrials.gov. 2015. http://www.clinicaltrials.gov/. Accessed 23 Sep 2015.
- 23.Lessem E, Cox H, Daniels C, et al. Access to new medications for the treatment of drug-resistant tuberculosis: patient, provider and community perspectives. In J Infect Dis. 2015;32:56–60.Google Scholar
- 24.Companion handbook to the WHO guidelines for the programmatic management of drug-resistant tuberculosis. Geneva: World Health Organization; 2014.Google Scholar
- 25.Hafkin J, Frias M, Hesseling A, et al. Pharmacokinetics and safety of delamanid in children ages 6–17 years with MDR TP [poster no. A-960]. In: Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC)/International Congress of Chemotherapy and Infection (ICC); 2015.Google Scholar