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Volume 22, Number 3—March 2016

Online Report

Global Progress and Challenges in Implementing New Medications for Treating Multidrug-Resistant Tuberculosis

Jennifer FurinComments to Author , Grania Brigden, Erica Lessem, Michael Rich, Laura Vaughan, and Sharonann Lynch
Author affiliations: Harvard Medical School, Boston, Massachusettes, USA (J. Furin); Médecins Sans Frontières Access Campaign, Geneva, Switzerland (G. Brigden, S. Lynch); Treatment Action Group, New York, NY, USA (E. Lessem); Brigham and Women’s Hospital, Boston (M. Rich); Partners In Health, Boston (M. Rich, L. Vaughan)

Main Article

Table 2

Summary points from the global call to action on the programmatic use of bedaquiline and delamanid to treat MDR TB

Point title Explanation
1. Quickstart Patients are started on routine regimens, which include DLM, by January 2016.
2. Optimal MDR TB treatment Technical assistance is provided for 25 countries by 2016 and 52 countries by 2017 for drafting implementation plans; implementation plans are adopted by 25 countries by 2016 and 52 countries by 2018; and BDQ and DLM are routinely used by 20 countries by end of 2016 and 52 countries by end of 2019. Key repurposed drugs (especially linezolid and clofazimine) should be on the national Essential Medicines List, and countries and national TB program should be using these drugs.
3. Regulatory status BDQ and DLM dossiers are submitted for registration in 25 countries by beginning of 2016 and 52 countries by 2017; and drugs are registered, or import waivers are in place, by 2016.
4. Pharmacovigilance The consortium† supports a flexible approach for countries implementing BDQ (such as sentinel pharmacovigilance), proposes a set of standardized data for monitoring and reporting on adverse events, and works toward a supranational body to collect and analyze data.
5. Procurement Forecasting of drugs is completed; procurement strategies are developed for 52 countries by 2018; and the turnaround time between ordering and drug delivery is reduced.

*BDQ, bedaquiline; DLM, delamanid; MDR TB, multidrug-resistant tuberculosis.
†The DR-TB STAT (Drug-Resistant TB Scale-up Treatment Action Team) task force.

Main Article