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USAID and Johnson & Johnson are launching a program on bedaquiline donation, a new drug

15.04.2015

On April 1, 2015, the United States Agency for International Development (USAID) and the Johnson & Johnson affiliate, Janssen Therapeutics, signed an agreement on launching a unique donation program to provide bedaquiline, a new drug to treat multi-drug resistant TB (including XDR-TB), for low- and middle-income countries. Owing to the program 30,000 MDR-TB patients in over 100 countries will be provided with new regimens  treatment, including bedaquiline, for a four year period. Along with medication supply, the countries will be provided with technical support in anti-TB program implementation and suggested necessary tools: national plans, forms, patient information, etc.

Bedaquiline is the first TB-drug that has been approved by the US Food and Drug Administration (FDA) in over 40 years.  The perspectives of bedaquiline use were presented on our website in October 2014, material can be reviewed here.

For Ukraine the program on bedaquiline donation to treat multi-drug resistant TB is a unique opportunity to help those patients, who cannot be provided with effective treatment within the existing state procurement. According to statistics there were 1188 such patients in Ukraine in 2013. The drugs for XDR-TB treatment are not purchased for the grant of the Global Fund, because the share for TB treatment makes only 30% of the grant. The cost of one bedaquiline treatment course for Ukraine comprises USD 3,000, but the complete medical treatment regimens requires other second-line drugs.  For XDR-TB treatment these drugs are purchased from the State Budget, but in the insufficient quantities, they are less effective than bedaquiline. The effectiveness of bedaquiline treatment may reach at least 57,6% as a minimum (according to clinical trials). This drug could be one of the key factors to overcome the growing threat of MDR-TB/XDR-TB epidemic in Ukraine.

It is not a difficult procedure for our country to become a participant of bedaquiline donation program. The Ministry of Health shall submit an official request for participation via Global Drug Facility (in accordance with WHO interim guidelines for bedaquiline use). We hope that the Ministry of Health takes the opportunity, as bedaquiline may actually be the last hope for recovery for many patients.

                                                                                                                                                                                                               

For reference. Internet resources for additional information on the subject:

  • Bedaquiline donation program:

https://stoptb.org/gdf/drugsupply/bedaquilineDonation.asp

  • WHO interim guidelines for bedaquiline use:

https://www.who.int/entity/tb/features_archive/bedaquilinelaunch/en/index.html
https://www.who.int/tb/publications/WHO_BDQimplementationplan.pdf