Strengthened capacity of India´s bedaquiline Conditional Access Programme for introducing new drugs and regimens

Int J Tuberc Lung Dis. 2020 Oct 1;24(10):1067-1072. doi: 10.5588/ijtld.20.0136.

Abstract

BACKGROUND: Addressing TB in India is critical to meeting global targets. With the scale-up of diagnostic networks and the availability of new TB drugs, India had the opportunity to improve the detection and treatment outcomes in drug-resistant TB (DR-TB).OBJECTIVE: To document how the introduction of new drugs and regimens is helping India improve the care of DR-TB patients.DESIGN: In 2016, India´s National TB Programme (NTP) introduced bedaquiline (BDQ) under a Conditional Access Programme (BDQ-CAP) at six sites after providing extensive training and strengthening laboratory testing, pre-treatment evaluation, active drug safety monitoring and management (aDSM) and follow-up systems.RESULTS: An interim analysis reflected earlier and better culture conversion rates: 83% of the 620 patients converted within a median time of 60 days. However, 248 serious adverse events were reported, including 73 deaths (12%) and 100 cardiotoxicity events (16.3%). Encouraged by the evidence of safety and efficacy of BDQ, the NTP took steps to systematically expand its access to cover the entire population by 2018.CONCLUSION: The cautious yet focused approach used to introduce BDQ under BDQ-CAP paved the way for the rapid introduction of delamanid, as well as the shorter treatment regimen and the all-oral regimen for DR-TB.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antitubercular Agents / adverse effects
  • Diarylquinolines / adverse effects
  • Humans
  • India
  • Pharmaceutical Preparations*
  • Tuberculosis, Multidrug-Resistant* / drug therapy

Substances

  • Antitubercular Agents
  • Diarylquinolines
  • Pharmaceutical Preparations
  • bedaquiline