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Bedaquiline: Rolling Out The First New TB Drug Since 1960

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Almost eight years ago, bedaquiline (BDQ) was approved by the US Food and Drug Administration for use in treatment of multidrug-resistant tuberculosis (MDR-TB) in adults.

This critical development in the fight against TB offered the first promise since the 1960s that humanity could overcome the rapid increase in strains of deadly MDR-TB.

Currently, while approximately half a million people globally are estimated to become ill with rifampicin-resistant (RR-) or MDR-TB annually, barely a third are diagnosed and receive appropriate second-line drug treatment.

By 2015, only 1,000 individuals had received bedaquiline because of challenges around cost, procurement, and regulations. Those numbers have since improved  - Johnson & Johnson stated earlier this year that it has provided some 210,000 people with bedaquiline since 2012 – but this is clearly insufficient with some four million having fallen ill to MDR-TB in the past eight years and other combination therapy regimes involving the other new drugs registered for the treatment of DRTB, pretomanid and delamanid, also experiencing a slow uptake.

In order for the international community to achieve its goal of ending TB by 2035, increasing access to BDQ will therefore be essential.

To help to facilitate greater access to BDQ globally, The Union is publishing a special thematic issue of its International Journal of Tuberculosis and Lung Disease BDQ for the treatment of people with MDR-TB to explore these challenges in-depth and to provide insights for policymakers, researchers and service providers in countries who want to scale up access to BDQ.

Included in this series:

  • The rationale and establishment of a donation agreement between Janssen Therapeutics (Beerse, Belgium) and the United States Agency for International Development (USAID)
  • the critical role of this technical assistance in supporting implementation
  • the experiences of Kyrgyzstan, which was able to achieve nationwide coverage in only 12 months, and the Americas region, which has seen a 21% increase in MDR/RR-TB in just 2 years
  • Issues around the lack of experience in conducting operational research in the national TB programme and associated delays in ethical reviews and approvals in The Philippines
  • How expedited regulatory approval and the generation of local patient safety and outcome data for policy makers has been key to success in India
  • the Expand New Drug markets for TB (endTB) Project which was highly successful in scaling up BDQ and delamanid use
  • Experiences in Eswatini in predicting poor patient outcomes among a large cohort receiving treatment with BDQ and/or delamanid
  • critical programmatic safety and efficacy data on BDQ which can be used to inform global policy guidance resulting from South Africa’s ambitious approach to MDR/RR-TB over the past decade including early adoption of new drugs, rapid diagnostics and decentralised models of care.
  • The need to develop and maintain capacity to adapt national guidance much more rapidly to implement guidance from the World Health Organization, now being issued on much more frequent basis

While many countries have successfully navigated changes in guidance relating to in HIV care provision, similar innovative approaches to TB care have so far proved to be slower and more difficult to implement.

Challenges to access have included the need for regulatory approval and registration in individual countries, high cost, procurement delays and insufficient data to support BDQ use in new drug combination regimens.

The lessons learned from the introduction of BDQ and scale-up of its use in various countries will be crucial in informing and expediting the adoption of other new drugs for the treatment of people with MDR-TB.