Background: The current tuberculosis (TB) treatment landscape has been studied extensively, but researchers rarely consider how it creates challenges or opportunities for future regimen change.

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).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 roll-out. Stakeholders more often cited concerns that were program-based (e.g., logistics and cost) rather than patient-focused (e.g., side effects), and patient representatives were seldom part of decision making. Decision-making 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 insufficient. 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. Future decision makers will benefit from strengthened decision-making bodies, patient input, early and comprehensive planning, and regimens and evidence that address local, practical implementation issues.

Despite the destruction of the National Tuberculosis Program (NTP) and basic health services by war and an uncertain security situation, the NTP, with assistance from many partners and REACH (the Rural Expansion of Afghanistan's Community-based Healthcare program), increased the number of patients receiving DOTS by 136% in 4 years (from 9261 cases in 2001 to 21851 in 2005), with an 86% treatment success rate. By focusing on rapidly expanding the number of facilities capable of providing tuberculosis (TB) diagnostic and treatment services and involving community health workers in case detection, referrals and home-based DOTS, REACH showed a 10-fold rise in the number of facilities providing TB services and a 380% increase in the number of sputum smear-positive pulmonary TB cases detected in 2 years (from 251/month in 2004 to 818/month in 2006) in 13 provinces. At the current rate of expansion, case detection and successful treatment of TB cases in Afghanistan will continue to expand rapidly. The NTP and REACH have demonstrated that expansion of TB services in Afghanistan is possible despite the challenges.


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