Pulmonology (Sep 2021)
Outcome of treatment of MDR-TB or drug-resistant patients treated with bedaquiline and delamanid: Results from a large global cohort
- S. Koirala,
- S. Borisov,
- E. Danila,
- A. Mariandyshev,
- B. Shrestha,
- N. Lukhele,
- M. Dalcolmo,
- S.R. Shakya,
- S. Miliauskas,
- L. Kuksa,
- S. Manga,
- A. Aleksa,
- J.T. Denholm,
- H.B. Khadka,
- A. Skrahina,
- S. Diktanas,
- M. Ferrarese,
- J. Bruchfeld,
- A. Koleva,
- A. Piubello,
- G.S. Koirala,
- Z.F. Udwadia,
- D.J. Palmero,
- M. Munoz-Torrico,
- R. GC,
- G. Gualano,
- V.I. Grecu,
- I. Motta,
- A. Papavasileiou,
- Y. Li,
- W. Hoefsloot,
- H. Kunst,
- J. Mazza-Stalder,
- M.-C. Payen,
- O.W. Akkerman,
- E. Bernal,
- V. Manfrin,
- A. Matteelli,
- H. Mustafa Hamdan,
- M. Nieto Marcos,
- J. Cadiñanos Loidi,
- J.J. Cebrian Gallardo,
- R. Duarte,
- N. Escobar Salinas,
- R. Gomez Rosso,
- R. Laniado-Laborín,
- E. Martínez Robles,
- S. Quirós Fernandez,
- A. Rendon,
- I. Solovic,
- M. Tadolini,
- P. Viggiani,
- E. Belilovski,
- M.J. Boeree,
- Q. Cai,
- E. Davidavičienė,
- L.D. Forsman,
- J. De Los Rios,
- J. Drakšienė,
- A. Duga,
- S.E. Elamin,
- A. Filippov,
- A. Garcia,
- I. Gaudiesiute,
- B. Gavazova,
- R. Gayoso,
- V. Gruslys,
- J. Jonsson,
- E. Khimova,
- G. Madonsela,
- C. Magis-Escurra,
- V. Marchese,
- M. Matei,
- C. Moschos,
- B. Nakčerienė,
- L. Nicod,
- F. Palmieri,
- A. Pontarelli,
- A. Šmite,
- M.B. Souleymane,
- M. Vescovo,
- R. Zablockis,
- D. Zhurkin,
- J.-W. Alffenaar,
- J.A. Caminero,
- L.R. Codecasa,
- J.-M. García-García,
- S. Esposito,
- L. Saderi,
- A. Spanevello,
- D. Visca,
- S. Tiberi,
- E. Pontali,
- R. Centis,
- L. D'Ambrosio,
- M. van den Boom,
- G. Sotgiu,
- G.B. Migliori
Affiliations
- S. Koirala
- Damien Foundation Nepal, Kathmandu, Nepal
- S. Borisov
- Moscow Research and Clinical Center for TB Control, Moscow Government’s Health Department, Moscow, Russian Federation
- E. Danila
- Clinic of Chest Diseases, Immunology and Allergology, Vilnius University Medical Faculty, Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
- A. Mariandyshev
- Northern State Medical University, Northern (Arctic) Federal University, Arkhangelsk, Russian Federation
- B. Shrestha
- Kalimati Chest Hospital/GENETUP/Nepal Anti Tuberculosis Association, Kathmandu, Nepal
- N. Lukhele
- TB/HIV, Hepatitis, & PMTCT Department, World Health Organization, Eswatini WHO Country Office, Mbabane, Eswatini
- M. Dalcolmo
- Reference Center Hélio Fraga, Fundação Oswaldo Cruz (Fiocruz)/Ministry of Health, Rio de Janeiro, Brazil
- S.R. Shakya
- Lumbini Provincial Hospital, Butwal, Nepal
- S. Miliauskas
- Department of Pulmonology, Lithuanian University of Health Sciences, Kaunas, Lithuania
- L. Kuksa
- MDR-TB Department, Riga East University Hospital for TB and Lung Disease Centre, Riga, Latvia
- S. Manga
- Department of Infectious Diseases, University National San Antonio Abad Cusco, Cusco, Peru
- A. Aleksa
- Department of Phthisiology and Pulmonology, Grodno State Medical University, Grodno, Belarus
- J.T. Denholm
- Victorian Tuberculosis Program, Melbourne Health, Department of Infectious Diseases, University of Melbourne, Melbourne, Australia
- H.B. Khadka
- Nepalgjunj TB Referral Center, TB Nepal, Nepalgunj, Nepal
- A. Skrahina
- Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus
- S. Diktanas
- Tuberculosis Department, 3rd Tuberculosis Unit, Republican Klaipėda Hospital, Klaipėda, Lithuania
- M. Ferrarese
- TB Reference Centre, Villa Marelli Institute, Niguarda Hospital, Milan, Italy
- J. Bruchfeld
- Division of Infectious Diseases, Department of Medicine, Solna, Karolinska Institute, Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden
- A. Koleva
- Pulmonology and Physiotherapy Department, Gabrovo Lung Diseases Hospital, Gabrovo, Bulgaria
- A. Piubello
- Damien Foundation, Niamey, Niger
- G.S. Koirala
- Nepal Anti Tuberculosis Association, Morang Branch, TB Clinic, Biratnagar, Province 1, Nepal
- Z.F. Udwadia
- Department of Respiratory Medicine, P.D. Hinduja National Hospital and MRC, Mumbai, India
- D.J. Palmero
- Pulmonology Division, Municipal Hospital F. J. Muñiz, Buenos Aires, Argentina
- M. Munoz-Torrico
- Clínica de Tuberculosis, Instituto Nacional De Enfermedades Respiratorias Ismael Cosio Villegas, Ciudad De Mexico, Mexico
- R. GC
- Damien Foundation, Midpoint District Community Memorial Hospital, Danda, Nawalparasi, Nepal
- G. Gualano
- Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases ‘L. Spallanzani’, IRCCS, Rome, Italy
- V.I. Grecu
- National Programme for Prevention, Surveillance and Control of Tuberculosis, Dolj Province, Romania
- I. Motta
- Department of Medical Science, Unit of Infectious Diseases, University of Torino, Italy
- A. Papavasileiou
- Department of Tuberculosis, Sotiria Athens Hospital of Chest Diseases, Athens, Greece
- Y. Li
- Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China
- W. Hoefsloot
- Radboud University Medical Center, Center Dekkerswald, Nijmegen, The Netherlands
- H. Kunst
- Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom
- J. Mazza-Stalder
- Division of Pulmonary Medicine, University Hospital of Lausanne CHUV, Lausanne, Switzerland
- M.-C. Payen
- Division of Infectious Diseases, CHU Saint-Pierre, Université Libre de Bruxelles (ULB), Brussels, Belgium
- O.W. Akkerman
- University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases and Tuberculosis, Groningen, The Netherlands; University of Groningen, University Medical Center Groningen, TB Center Beatrixoord, Haren, The Netherlands
- E. Bernal
- Unidad de Enfermedades Infecciosas, Hospital General Universitario Reina Sofia, Murcia, Spain
- V. Manfrin
- Infectious and Tropical Diseases Operating Unit, S. Bortolo Hospital, Vicenza, Italy
- A. Matteelli
- Clinic of Infectious and Tropical Diseases, WHO Collaborating Centre for TB Elimination and TB/HIV Co-infection, University of Brescia, Brescia, Italy
- H. Mustafa Hamdan
- MDR-TB Department, Abu Anga Teaching Hospital, Khartoum, Sudan
- M. Nieto Marcos
- Internal Medicine Department, Hospital Doctor Moliner, Valencia, Spain
- J. Cadiñanos Loidi
- Internal Medicine Department, Hospital General de Villalba, Collado Villalba, Spain
- J.J. Cebrian Gallardo
- Unidad de Neumología, Agencia Sanitaria Costa del Sol, Marbella, Spain
- R. Duarte
- National Reference Centre for MDR-TB, Hospital Centre Vila Nova de Gaia, Department of Pneumology, Public Health Science and Medical Education Department, Faculty of Medicine, University of Porto, Porto, Portugal
- N. Escobar Salinas
- Division of Disease Prevention and Control, Department of Communicable Diseases, National Tuberculosis Control and Elimination Programme, Ministry of Health, Santiago, Chile
- R. Gomez Rosso
- National Institute of Respiratory and Environmental Diseases ¨Prof. Dr. Juan Max Boettner¨ Asunción, Paraguay
- R. Laniado-Laborín
- Universidad Autónoma de Baja California, Baja California, Mexico; Clínica de Tuberculosis del Hospital General de Tijuana, Tijuana, Baja California, Mexico
- E. Martínez Robles
- Internal Medicine Department, Hospital de Cantoblanco- Hospital General Universitario La Paz, Madrid, Spain
- S. Quirós Fernandez
- Pneumology Department, Tuberculosis Unit, Hospital de Cantoblanco- Hospital General Universitario La Paz, Madrid, Spain
- A. Rendon
- Centro de Investigación, Prevención y Tratamiento de Infecciones Respiratorias CIPTIR, University Hospital of Monterrey UANL (Universidad Autonoma de Nuevo Leon), Monterrey, Mexico
- I. Solovic
- National Institute for TB, Lung Diseases and Thoracic Surgery, Vysne Hagy, Catholic University Ruzomberok, Slovakia
- M. Tadolini
- Infectious Diseases Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant’Orsola, Bologna, Italy; Department of Medical and Surgical Sciences Alma Mater Studiorum University of Bologna, Bologna, Italy
- P. Viggiani
- Reference Center for MDR-TB and HIV-TB, Eugenio Morelli Hospital, Sondalo, Italy
- E. Belilovski
- Moscow Research and Clinical Center for TB Control, Moscow Government’s Health Department, Moscow, Russian Federation
- M.J. Boeree
- Radboud University Medical Center, Center Dekkerswald, Nijmegen, The Netherlands
- Q. Cai
- Zhejiang Integrated Traditional and Western Medicine Hospital, Hangzhou, China
- E. Davidavičienė
- National TB Registry, Public Health Department, Ministry of Health, Vilnius, Lithuania; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
- L.D. Forsman
- Division of Infectious Diseases, Department of Medicine, Solna, Karolinska Institute, Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden
- J. De Los Rios
- Centro de Excelencia de TBMDR, Hospital Nacional Maria Auxiliadora, Lima, Peru
- J. Drakšienė
- Tuberculosis Department, 3rd Tuberculosis Unit, Republican Klaipėda Hospital, Klaipėda, Lithuania
- A. Duga
- Baylor College of Medicine, Children’s Foundation, Mbabane, Eswatini; National Pharmacovigilance Center, Eswatini Ministry of Health, Matsapha, Eswatini
- S.E. Elamin
- MDR-TB Department, Abu Anga Teaching Hospital, Khartoum, Sudan
- A. Filippov
- Moscow Research and Clinical Center for TB Control, Moscow Government’s Health Department, Moscow, Russian Federation
- A. Garcia
- Pulmonology Division, Municipal Hospital F. J. Muñiz, Buenos Aires, Argentina
- I. Gaudiesiute
- Department of Pulmonology, Lithuanian University of Health Sciences, Kaunas, Lithuania
- B. Gavazova
- Improve the Sustainability of the National TB Programme, Sofia, Bulgaria
- R. Gayoso
- Reference Center Hélio Fraga, Fundação Oswaldo Cruz (Fiocruz)/Ministry of Health, Rio de Janeiro, Brazil
- V. Gruslys
- Clinic of Chest Diseases, Immunology and Allergology, Vilnius University Medical Faculty, Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
- J. Jonsson
- Department of Public Health Analysis and Data Management, Public Health Agency of Sweden, Solna, Sweden
- E. Khimova
- Northern State Medical University, Northern (Arctic) Federal University, Arkhangelsk, Russian Federation
- G. Madonsela
- Eswatini National Aids Programme, Mbabane, Eswatini
- C. Magis-Escurra
- Radboud University Medical Center, Center Dekkerswald, Nijmegen, The Netherlands
- V. Marchese
- Clinic of Infectious and Tropical Diseases, WHO Collaborating Centre for TB Elimination and TB/HIV Co-infection, University of Brescia, Brescia, Italy
- M. Matei
- Hospital of Pneumophtisiology Leamna, Dolj Province, Romania; University of Medicine and Pharmacy, Craiova, Romania
- C. Moschos
- Department of Tuberculosis, Sotiria Athens Hospital of Chest Diseases, Athens, Greece
- B. Nakčerienė
- National TB Registry, Public Health Department, Ministry of Health, Vilnius, Lithuania; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
- L. Nicod
- Division of Pulmonary Medicine, University Hospital of Lausanne CHUV, Lausanne, Switzerland
- F. Palmieri
- Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases ‘L. Spallanzani’, IRCCS, Rome, Italy
- A. Pontarelli
- Respiratory Infectious Diseases Unit, Cotugno Hospital, A.O.R.N. dei Colli, Naples, Italy
- A. Šmite
- MDR-TB Department, Riga East University Hospital for TB and Lung Disease Centre, Riga, Latvia
- M.B. Souleymane
- Damien Foundation, Niamey, Niger
- M. Vescovo
- Pulmonology Division, Municipal Hospital F. J. Muñiz, Buenos Aires, Argentina
- R. Zablockis
- Clinic of Chest Diseases, Immunology and Allergology, Vilnius University Medical Faculty, Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
- D. Zhurkin
- Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus
- J.-W. Alffenaar
- University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, Australia; Westmead Hospital, Sydney, Australia; Marie Bashir Institute of Infectious Diseases and Biosecurity, University of Sydney, Sydney, Australia
- J.A. Caminero
- Pneumology Department, Hospital General de Gran Canaria “Dr. Negrin”, Las Palmas de Gran Canaria, Spain; Vital Strategies, New York, USA
- L.R. Codecasa
- TB Reference Centre, Villa Marelli Institute, Niguarda Hospital, Milan, Italy
- J.-M. García-García
- Tuberculosis Research Programme (PII-TB), SEPAR, Barcelona, Spain
- S. Esposito
- Pediatric Clinic, Pietro Barilla Children’s Hospital, University of Parma, Parma, Italy
- L. Saderi
- Clinical Epidemiology and Medical Statistics Unit, Department of z, University of Sassari, Sassari, Italy
- A. Spanevello
- Division of Pulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy; Department of Medicine and Surgery, Respiratory Diseases, University of Insubria, Tradate, Varese-Como, Italy
- D. Visca
- Division of Pulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy; Department of Medicine and Surgery, Respiratory Diseases, University of Insubria, Tradate, Varese-Como, Italy
- S. Tiberi
- Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom; Department of Infection, Royal London and Newham Hospitals, Barts Health NHS Trust, London, United Kingdom
- E. Pontali
- Department of Infectious Diseases, Galliera Hospital, Genova, Italy
- R. Centis
- Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy
- L. D'Ambrosio
- Public Health Consulting Group, Lugano, Switzerland
- M. van den Boom
- World Health Organization Regional office for Europe, Copenhagen, Denmark
- G. Sotgiu
- Clinical Epidemiology and Medical Statistics Unit, Department of z, University of Sassari, Sassari, Italy
- G.B. Migliori
- Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy; Corresponding author at: Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Via Roncaccio 16, Tradate, Varese, 21049, Italy.
- Journal volume & issue
-
Vol. 27,
no. 5
pp. 403 – 412
Abstract
The World Health Organization (WHO) recommends countries introduce new anti-TB drugs in the treatment of multidrug-resistant tuberculosis.The aim of the study is to prospectively evaluate the effectiveness of bedaquiline (and/or delamanid)- containing regimens in a large cohort of consecutive TB patients treated globally.This observational, prospective study is based on data collected and provided by Global Tuberculosis Network (GTN) centres and analysed twice a year.All consecutive patients (including children/adolescents) treated with bedaquiline and/or delamanid were enrolled, and managed according to WHO and national guidelines.Overall, 52 centres from 29 countries/regions in all continents reported 883 patients as of January 31st 2021, 24/29 countries/regions providing data on 100% of their consecutive patients (10–80% in the remaining 5 countries).The drug-resistance pattern of the patients was severe (>30% with extensively drug-resistant -TB; median number of resistant drugs 5 (3−7) in the overall cohort and 6 (4−8) among patients with a final outcome).For the patients with a final outcome (477/883, 54.0%) the median (IQR) number of months of anti-TB treatment was 18 (13−23) (in days 553 (385–678)). The proportion of patients achieving sputum smear and culture conversion ranged from 93.4% and 92.8% respectively (whole cohort) to 89.3% and 88.8% respectively (patients with a final outcome), a median (IQR) time to sputum smear and culture conversion of 58 (30−90) days for the whole cohort and 60 (30−100) for patients with a final outcome and, respectively, of 55 (30−90) and 60 (30−90) days for culture conversion.Of 383 patients treated with bedaquiline but not delamanid, 284 (74.2%) achieved treatment success, while 25 (6.5%) died, 11 (2.9%) failed and 63 (16.5%) were lost to follow-up.
