Steps of bedaquline implementation in Georgia

Introduction: Drug-resistant tuberculosis (DR-TB) remains one of the major health-care problems in Georgia. In 2014 DR-TB was found in 11, 6% of new TB cases. Successful treatment outcome with second line anti-TB drugs was only 41% in 2013 cohort. The severity of the problem has led to the implementation of the new DR-TB treatment program. Aim: To overview the steps of implementation Bedaquline (Bdq) for the treatment of DR-TB in Georgia. Interventions: Georgia was one of the first countries which started use of Bdq through compassionate use program (CU) in 2011 and from 30.07.14 continued in the framework of new DR-TB treatment program with the support of MSF-France. Georgia developed a National Bedaquiline Implementation Plan based on the latest recommendations of WHO. To decentralize the DR-TB patients9 enrollment in new regimens and to monitor the treatment implementation an innovative approach of “Mobile Consilium” was elaborated. Early adoption of the new treatment regimens made Georgia a primary candidate to receive free courses of Bdq through USAID and Janssen Therapeutics Bdq Donation Program in July 2015 for programmatic use. Results: From 2011 to July 2014, 12 patients were enrolled in Bdq CU program. All of them finished course with successful outcome. From 30.07.14 to 01.02.16, 192 patients were discussed for new regimens and 165 started treatment with Bdq, among them - 12 from penitential system. Bdq showed good safety and tolerability-only in 3% of cases treatment was temporary stopped due to severe side effects. Conclusion: Administration of the new DR-TB treatment regimens in line with active drug safety monitoring, seem to have promising effects on the treatment outcomes and epidemiological situation in Georgia.