Tuberculosis regimen change in high-burden countries.

BACKGROUND: Experience with past tuberculosis (TB) regimen changes can guide future regimen changes. METHODS: To explore the process, major players and procedural success factors for recent public sector TB regimen changes, we conducted 166 interviews of country stakeholders in 21 of the 22 TB high-burden countries (HBCs). RESULTS: Stakeholders described 40 distinct regimen changes for drug-susceptible TB. Once countries committed to considering a change, the average timing was ~1 year for decision-making and ~2 years for rollout. Stakeholders more often cited concerns that were program-based (e.g., logistics and cost) rather than p atient-focused (e.g., side effects), and patient representatives were seldom part of decision making. Decisionmaking bodies in higher-income HBCs had more formalized procedures and fewer international participants. Pilot studies focused on logistics were more common than effectiveness studies, and the evidence base was often felt to be insuffi cient. Once implementation started, weaknesses in drug management were often exposed, with additional complications if local manufacturing was required. Best practices for regimen change included early engagement of budgeting staff, procurement staff, regulators and manufacturers. CONCLUSIONS: Future decision makers will benefi t