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Global TB CAB

Meeting Reports

Treatment Action Group, along with other stakeholders in tuberculosis product development and access, identified the need for TB research-literate community activists. In 2011, TAG initiated the Global Tuberculosis Community Advisory Board (TB CAB) to act in an advisory capacity to institutions conducting clinical trials of new TB drugs, treatment regimens, diagnostics, and vaccines, and to provide input on study design, early access, regulatory approval, postmarketing, and implementation strategies.

The TB CAB has taken on several advocacy initiatives since its inception, including:

  • Encouraging the two leading stringent regulatory authorities, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to harmonize their guidance on accepted endpoints for drug trials. The FDA confirmed that early culture conversion is being accepted as a clinical endpoint for accelerated approval, and discussed the potential of looking at other endpoints.
  • Urging Janssen, Otsuka, the FDA, and the EMA to ensure that bedaquiline and delamanid (the two most advanced candidates in clinical development for TB) are safe to use together, as they likely will be used together once approved. The U.S. National Institutes of Health is now coordinating efforts to determine what further research is necessary to evaluate if bedaquiline and delamanid are safe to use together, and conduct any requisite studies;
  • Enabling pre-approval access to bedaquiline and delamanid for select providers to administer them to patients with no other treatment options. This includes requesting Otsuka to make delamanid available for pre-approval access, and supporting South African advocates, doctors, and organizations in their call for early access to bedaquiline by sending an open letter to the South African Medicines Control Council. Though the MCC’s initial response indicated a lack of cooperation, bedaquiline is now available for eligible patients at certain centers in South Africa;
  • Advocating for a reduction in the price of the GeneXpert machines and test cartridges to expand access to rapid TB diagnosis in an open letter to Cepheid, the manufacturer of GeneXpert. In early July 2012, an agreement to reduce the price of Xpert MTB/RIF cartridges was made between the manufacturer and UNITAID, the President’s Emergency Plan for AIDS Relief (PEPFAR), the United States Agency for International Development, and the Bill & Melinda Gates Foundation to reduce the cartridge price to US$10; however, this only applies to a set number of preapproved public-sector purchasers, and the US$17,000 price tag of the GeneXpert machine itself is still unacceptable;
  • Demanding that companies responsibly market their diagnostic tests to ensure appropriate use in the field. The TB CAB urged Qiagen to look into the marketing of its QuantiFERON-TB Gold test for latent TB in India, where the private sector is inappropriately using the test to diagnose active TB. Similarly, the group sent a letter to Immunoshop to stop similar use of the TB Platinum test for active TB in India; and
  • Hosting the website, which provides news, updates, and resources on TB.