Delamanid expanded access novel treatment of drug resistant tuberculosis

Abstract

Roxana Rustomjee,1 Alimuddin Zumla2,31South African Medical Research Council, Cape Town, South Africa; 2Division of Infection and Immunity, University College London, London, UK; 3NIHR Biomedical Research Centre, University College Hospitals NHS Foundation Trust, London, UKAbstract: Tuberculosis (TB) remains a global emergency and is one of the most common infectious disease causes of death in developing countries. Current treatment regimens for multi-drug resistant TB are associated with low treatment success rates, are toxic, and require long duration of treatment. The need for shorter and more effective treatment regimens is urgent. Delamanid (Deltyba, or formerly known as OPC-67683) is a new dihydro-imidazooxazole anti-TB drug active against resistant forms of pulmonary TB. Delamanid kills Mycobacterium tuberculosis by inhibiting the synthesis of mycolic acids required for cell wall synthesis. Whilst delamanid has been included in the WHO Model List of Essential Medicine by the World Health Organization Expert Committee on Selection and Use of Essential Medicines and in international guidance for the treatment of multi-drug resistant TB since April 2014, its access in countries with the greatest need, has proven challenging. This review provides an update on currently available clinical safety and efficacy data on delamanid and offers a discussion on research priorities and recommendations for expedited, expanded access.Keywords: delamanid, tuberculosis, drug resistance, MDR-TB, expanded access