Strengthening the market for new drugs for the treatment of multidrug-resistant tuberculosis (MDR-TB).
Existing standard treatment for MDR-TB is lengthy, expensive and often ineffective, with many dramatic side effects including hearing loss and psychosis.
This project conducts an observational study and a clinical trial of two new MDR-TB drugs: bedaquiline and delamanid. These are being administered alongside existing TB regimens in 15 countries with a high burden of the disease. The treatment regimens for the new drugs are shorter than the existing MDR-TB regimens and are presumed to be more effective and less toxic. The project also aims to remove policy and market barriers that limit the new drugs’ widespread availability and uptake.
Progress so far
As of April 2017, all 15 project countries had bedaquiline available, and 14 of them started the observational study. Delamanid is also available in 12 of the 15 endTB countries. The clinical trial for the new drugs began in February 2017 in Georgia, with five other countries (Kazakhstan, Kyrgyzstan, Lesotho, Peru and South Africa) expecting to start enrollment before the end of 2017. Significant work has been carried out by the Consortium members to promote incorporation of the principles of patient management with new TB drugs into the national guidelines of the project countries and to facilitate the sharing of knowledge and dissemination of evidence that support the use of new TB drugs on a global level.