Eliminating the Category II Retreatment Regimen from National Tuberculosis Programme Guidelines: The Georgian experience/Suppression Du Schema De Retraitement De Categorie II Des Directives Therapeutiques Nationales Du Programme De Lutte Contre la Tuberculose: L'experience georgienne/Eliminacion De Las Pautas De Repeticion del Tratamiento De Categoria II De Las Directrices del Programa Nacional Contra la Tuberculosis: El Caso De Georgia

Introduction Management of patients who have been previously treated for tuberculosis (TB) has been a cause of much debate. (1) In 1991, the World Health Organization (WHO) recommended the use of the II retreatment for all patients with a prior history of TB treatment. (2,3) The category II regimen added streptomycin to the first-line agents and extended treatment to 8 months. Multiple observational studies have examined outcomes among individuals receiving category II treatment and shown mixed results. Overall success rates are in the 60-80% range, (4,5) with notably worse outcomes seen among patients who failed or relapsed after their initial treatment episode. (6,7) WHO TB treatment guidelines published in 2010 recommend treatment guided by drug susceptibility testing--using rapid, molecular tests where possible--for all previously treated patients. (3) The category II regimen, however, is still recommended for certain patients who return after default or relapse in settings with low risk of multidrug-resistant TB (MDR-TB). There is little documentation concerning implementation of these guidelines and category II remains the standard of care for patients requiring retreatment in most settings in the world. This paper presents the experience of Georgia--a country with a substantial population of previously treated patients and high rates of MDR-TB--in eliminating category II therapy from its National TB Program (NTP) guidelines. Local setting Georgia is a country of 4.4 million people located in the South Caucasus region. The WHO TB case notification rate is 102 per 100000 population (8) All Georgian TB patients receive culture and drug susceptibility testing as a standard part of diagnosis. In 2009, routine surveillance found MDR-TB in 10.6% of newly diagnosed patients and 32.5% of previously treated cases. (9) Programmatic management of drug-resistance TB in Georgia was started in 2006 and in 2009 the country achieved universal access to MDR-TB treatment. Approach An operational assessment of the utility of category II in Georgia was done in July and August 2010, led by members of the Georgian NTP with a WHO-recruited consultant. The steps taken were: (i) programme review, (ii) consensus building, and (iii) implementation planning (Table 1). Programme review Outcomes of patients treated with category II were assessed in addition to the local epidemiology and programme resources in Georgia. More than 6500 patients received category II therapy between 2007 and 2009 and their outcomes are shown in Table 2. Georgia has a high burden of TB, particularly drug-resistant TB. Prevalence of HIV in the country is low ( Box 1. Summary of main lessons learnt * The National Tuberculosis Program initiated and led the policy decision and worked closely with health-care providers to build consensus. * Evidence-based analysis was used to support the decision. * Time and resources were committed to expand access to rapid, molecular-based drug susceptibility testing and management of drug-resistance. Consensus building Following this review, the NTP decided to no longer recommend category II treatment in Georgia because of: (i) poor outcomes among patients on category II therapy; (ii) high rates of streptomycin resistance among previously treated patients; (iii) lack of evidence to support category II; and (iv) widespread access to both drug susceptibility testing and treatment for drug-resistant TB. The NTP concluded that patients with documented resistance, including those with mono-resistance, would receive a regimen based on drug susceptibility test results. …