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

• Published in: The international journal of tuberculosis and lung disease Vol. 24; no. 10; pp. 1067 - 1072
• Main Authors: Sachdeva, K. S., Arora, N., Solanki, R., Singla, R., Sarin, R., Bhatnagar, A., Khanna, A., Atahavale, A., Shridhar, R., Barua, S. R., Parmar, M., Farooq, S. I., Ramachandran, R., Alavadi, U., Swamickan, R., Tonsing, J., Patel, Y., Singla, N.
• Format: Journal Article
• Language: English
• Published: France International Union Against Tuberculosis and Lung Disease 01.10.2020
• Subjects: Adsm; Antitubercular Agents - adverse effects; Bdq Cap; Delamanid; Diarylquinolines - adverse effects; Drtb; Humans; India; Pharmaceutical Preparations; Tuberculosis; Tuberculosis, Multidrug-Resistant - drug therapy; India
• ISSN: 1027-3719; 1815-7920
• DOI: 10.5588/ijtld.20.0136

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.