L Guglielmetti1, C Hewison2, Z Avaliani3, J Hughes4, N Kiria3, N Lomtadze3, N Ndjeka5, S Setkina6, A Shabangu7, W Sikhondze8, A Skrahina9, N Veziris10, J Furin11. 1. Sanatorium, Centre Hospitalier de Bligny, Briis-sous-Forges, France; Médecins Sans Frontières, Paris, France; Sorbonne Université, Université Pierre et Marie Curie 06, Unité 1135, Team E13 (Bactériologie), CR7 Institut National de la Santé et de la Recherche Médicale, Centre d'Immunologie et des Maladies Infectieuses, Paris, France. 2. Médecins Sans Frontières, Paris, France. 3. National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia. 4. Médecins Sans Frontières, Khayelitsha, South Africa. 5. National Department of Health, Pretoria, South Africa. 6. Center for Examinations and Tests in Health Service, Republican Unitary Enterprise, Minsk, Republic of Belarus. 7. National TB Referral Hospital, Manzini, Swaziland. 8. National Tuberculosis Control Programme, Manzini, Swaziland. 9. Republican Scientific and Practical Centre for Pulmonology and TB, Minsk, Belarus. 10. Sorbonne Université, Université Pierre et Marie Curie 06, Unité 1135, Team E13 (Bactériologie), CR7 Institut National de la Santé et de la Recherche Médicale, Centre d'Immunologie et des Maladies Infectieuses, Paris, France; Assistance Publique Hôpitaux de Paris, Centre National de Référence des Mycobactéries et de la Résistance des Mycobactéries aux Antituberculeux, Bactériologie-Hygiène, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Paris, France. 11. Harvard Medical School, Boston, Massachusetts, USA.
Abstract
BACKGROUND: For the first time in almost 50 years, there are new drugs available for the treatment of tuberculosis (TB), including bedaquiline (BDQ) and delamanid (DLM). The rate of introduction, however, has not kept pace with patient needs. It is estimated that as many as 23% of multidrug-resistant TB (MDR-TB) patients have an indication for receiving BDQ. As this is the first time the MDR-TB community is introducing new medications, it is important to understand how implementation can be developed in a variety of settings. METHODS: A qualitative assessment of country TB programs in which more than 5% of MDR-TB patients were started on BDQ under program conditions. RESULTS: National TB programs in Belarus, France, Georgia, South Africa, and Swaziland all started sizeable cohorts of patients on BDQ in 2015. Common factors observed in these programs included experience with compassionate use/expanded access, support from implementing partners, and adequate national or donor-supported budgets. Barriers to introduction included restriction of BDQ to the in-patient setting, lack of access to companion drugs, and the development of systems for pharmacovigilance. CONCLUSION: The five countries in this paper are examples of the introduction of new therapeutic options for the treatment of TB.
BACKGROUND: For the first time in almost 50 years, there are new drugs available for the treatment of tuberculosis (TB), including bedaquiline (BDQ) and delamanid (DLM). The rate of introduction, however, has not kept pace with patient needs. It is estimated that as many as 23% of multidrug-resistant TB (MDR-TB) patients have an indication for receiving BDQ. As this is the first time the MDR-TB community is introducing new medications, it is important to understand how implementation can be developed in a variety of settings. METHODS: A qualitative assessment of country TB programs in which more than 5% of MDR-TB patients were started on BDQ under program conditions. RESULTS: National TB programs in Belarus, France, Georgia, South Africa, and Swaziland all started sizeable cohorts of patients on BDQ in 2015. Common factors observed in these programs included experience with compassionate use/expanded access, support from implementing partners, and adequate national or donor-supported budgets. Barriers to introduction included restriction of BDQ to the in-patient setting, lack of access to companion drugs, and the development of systems for pharmacovigilance. CONCLUSION: The five countries in this paper are examples of the introduction of new therapeutic options for the treatment of TB.
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