The Bedaquiline Donation Program: progress and lessons learned after 4 years of implementation

Area of Science:

• Global health
• Pharmaceutical development
• Infectious disease research

Background:

• Drug-resistant tuberculosis (DR-TB) poses a significant global health challenge.
• Bedaquiline (BDQ) is a critical new drug for treating DR-TB.
• Limited access to new TB drugs has historically hindered treatment progress.

Purpose of the Study:

• To evaluate the effectiveness of the Bedaquiline Donation Program in accelerating access to BDQ.
• To assess the program's role in preparing national TB programs for new drug introductions.
• To identify challenges and gather data on BDQ use in real-world settings.

Main Methods:

• A global public-private partnership between USAID and Janssen Therapeutics.
• Commitment of 30,000 treatment courses of BDQ to over 100 countries.
• Distribution of BDQ through the Global Drug Facility (GDF).

Main Results:

• By April 2019, 80 countries had ordered 104,344 BDQ courses.
• 33,119 BDQ courses were delivered, with the remainder pending.
• The program demonstrated accelerated access to a novel TB therapeutic.

Conclusions:

• The Bedaquiline Donation Program successfully accelerated access to a new drug for DR-TB.
• Sustained technical support and investment beyond drug costs are crucial for successful DR-TB treatment transformation.
• New TB drugs offer hope for shorter, simpler, and more tolerable treatment regimens.