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Article ; Online: TB research and innovation in Latin America.

Manga, Selene

European respiratory review : an official journal of the European Respiratory Society

2021 Volume 30, Issue 159

Abstract: The production of tuberculosis (TB) research and innovation in Latin America during the past decade has notably improved. Its role in the acceleration of the decline of the average annual TB incidence rate by 2.5% from 2017 to 2018 is still unclear, but ... ...

Abstract	The production of tuberculosis (TB) research and innovation in Latin America during the past decade has notably improved. Its role in the acceleration of the decline of the average annual TB incidence rate by 2.5% from 2017 to 2018 is still unclear, but it is looking promising that the region will meet the End TB Strategy targets set for 2030. Well performed and high-quality research and evidence is critical for improving national TB control programme outcomes. In Latin America, this need is most apparent when responding to the multidrug-resistant TB epidemic.There is an urgent need for technological breakthroughs to accelerate by an average of 17% per year if the decline in TB incidence rate is to meet the target set for 2030. Intensified research and innovation, identified as one of the three essential pillars of the End TB Strategy, has scarcely been achieved in the region due to political and economic context. This will be analysed further in this article.
MeSH term(s)	Humans ; Incidence ; Latin America/epidemiology ; Tuberculosis/diagnosis ; Tuberculosis/drug therapy ; Tuberculosis/epidemiology ; Tuberculosis, Multidrug-Resistant/diagnosis ; Tuberculosis, Multidrug-Resistant/drug therapy ; Tuberculosis, Multidrug-Resistant/epidemiology
Language	English
Publishing date	2021-03-24
Publishing country	England
Document type	Journal Article
ZDB-ID	1077620-5
ISSN	1600-0617 ; 0905-9180
ISSN (online)	1600-0617
ISSN	0905-9180
DOI	10.1183/16000617.0107-2020
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Article: Caught in the crossfires: the Virchow Prize, its inaugural winner, and the quest to decolonise global health.

Bhopal, Anand / Getnet, Fentabil / Manga, Selene

BMJ global health

2023 Volume 8, Issue 7

Language	English
Publishing date	2023-07-20
Publishing country	England
Document type	Journal Article ; Comment
ISSN	2059-7908
ISSN	2059-7908
DOI	10.1136/bmjgh-2023-013272
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Article: Performance of a lateral flow immunochromatography test for the rapid diagnosis of active tuberculosis in a large multicentre study in areas with different clinical settings and tuberculosis exposure levels.

Manga, Selene / Perales, Rocio / Reaño, Maria / D'Ambrosio, Lia / Migliori, Giovanni Battista / Amicosante, Massimo

Journal of thoracic disease

2016 Volume 8, Issue 11, Page(s) 3307–3313

Abstract: Background: Tuberculosis (TB) continues to cause an outsized burden of morbidity and mortality worldwide, still missing efficient and largely accessible diagnostic tools determining an appropriate control of the disease. Serological tests have the ... ...

Abstract	Background: Tuberculosis (TB) continues to cause an outsized burden of morbidity and mortality worldwide, still missing efficient and largely accessible diagnostic tools determining an appropriate control of the disease. Serological tests have the potentially to impact TB diagnosis, in particular in extreme clinical settings. Methods: The diagnostic performances of the TB-XT HEMA EXPRESS (HEMA-EXPRESS) immunochromatographic rapid test for active TB diagnosis, based on use of multiple Results: The TB prevalence (overall 20.5%) varied between 4.0% and 41.1% in the different study groups. Overall, the HEMA-EXPRESS test had 30.6% sensitivity (range 3.9-77.9%) and 84.6% specificity (range 51.6-97.3%). A significant inverse correlation between test accuracy (overall 73.5%, range 40.4-96.4%) and TB prevalence in the various study populations was observed (Pearson's r=-0.7985; P=0.05). Conclusions: HEMA-EXPRESS, is rapid and relatively inexpensive test suitable for routine use in TB diagnosis. In low TB prevalence conditions, test performance appears in line with WHO Target Product Profile for TB diagnostics. Performances appear suboptimal in high TB prevalence settings. Appropriate set-up in operative clinical settings has to be considered for novel serological tests for TB diagnosis, particularly for formats suitable for point-of-care use.
Language	English
Publishing date	2016-12-27
Publishing country	China
Document type	Journal Article
ZDB-ID	2573571-8
ISSN	2077-6624 ; 2072-1439
ISSN (online)	2077-6624
ISSN	2072-1439
DOI	10.21037/jtd.2016.11.51
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Article: Screening for Tuberculosis in Migrants: A Survey by the Global Tuberculosis Network.

D'Ambrosio, Lia / Centis, Rosella / Dobler, Claudia C / Tiberi, Simon / Matteelli, Alberto / Denholm, Justin / Zenner, Dominik / Al-Abri, Seif / Alyaquobi, Fatma / Arbex, Marcos Abdo / Belilovskiy, Evgeny / Blanc, François-Xavier / Borisov, Sergey / Carvalho, Anna Cristina C / Chakaya, Jeremiah Muhwa / Cocco, Nicola / Codecasa, Luigi Ruffo / Dalcolmo, Margareth Pretti / Dheda, Keertan /

Dinh-Xuan, Anh Tuan / Esposito, Susanna R / García-García, José-María / Li, Yang / Manga, Selene / Marchese, Valentina / Muñoz Torrico, Marcela / Pontali, Emanuele / Rendon, Adrián / Rossato Silva, Denise / Singla, Rupak / Solovic, Ivan / Sotgiu, Giovanni / van den Boom, Martin / Nhung, Nguyen Viet / Zellweger, Jean-Pierre / Migliori, Giovanni Battista

Antibiotics (Basel, Switzerland)

2021 Volume 10, Issue 11

Abstract: Tuberculosis (TB) does not respect borders, and migration confounds global TB control and elimination. Systematic screening of immigrants from TB high burden settings and-to a lesser degree TB infection (TBI)-is recommended in most countries with a low ... ...

Abstract	Tuberculosis (TB) does not respect borders, and migration confounds global TB control and elimination. Systematic screening of immigrants from TB high burden settings and-to a lesser degree TB infection (TBI)-is recommended in most countries with a low incidence of TB. The aim of the study was to evaluate the views of a diverse group of international health professionals on TB management among migrants. Participants expressed their level of agreement using a six-point Likert scale with different statements in an online survey available in English, French, Mandarin, Spanish, Portuguese and Russian. The survey consisted of eight sections, covering TB and TBI screening and treatment in migrants. A total of 1055 respondents from 80 countries and territories participated between November 2019 and April 2020. The largest professional groups were pulmonologists (16.8%), other clinicians (30.4%), and nurses (11.8%). Participants generally supported infection control and TB surveillance established practices (administrative interventions, personal protection, etc.), while they disagreed on how to diagnose and manage both TB and TBI, particularly on which TBI regimens to use and when patients should be hospitalised. The results of this first knowledge, attitude and practice study on TB screening and treatment in migrants will inform public health policy and educational resources.
Language	English
Publishing date	2021-11-05
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2681345-2
ISSN	2079-6382
ISSN	2079-6382
DOI	10.3390/antibiotics10111355
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Article ; Online: Outcomes of patients with drug-resistant-tuberculosis treated with bedaquiline-containing regimens and undergoing adjunctive surgery.

Borisov, Sergey E / D'Ambrosio, Lia / Centis, Rosella / Tiberi, Simon / Dheda, Keertan / Alffenaar, Jan-Willem / Amale, Rohit / Belilowski, Evgeny / Bruchfeld, Judith / Canneto, Barbara / Denholm, Justin / Duarte, Raquel / Esmail, Aliasgar / Filippov, Alex / Davies Forsman, Lina / Gaga, Mina / Ganatra, Shashank / Igorevna, Gaida Anastasia / Lazaro Mastrapa, Barbara /

Manfrin, Vinicio / Manga, Selene / Maryandyshev, Andrey / Massard, Gilbert / González Montaner, Pablo / Mullerpattan, Jai / Palmero, Domingo Juan / Pontarelli, Agostina / Papavasileiou, Apostolos / Pontali, Emanuele / Romero Leyet, Rodolfo / Spanevello, Antonio / Udwadia, Zarir Farokh / Viggiani, Pietro / Visca, Dina / Sotgiu, Giovanni / Migliori, Giovanni Battista

The Journal of infection

2018 Volume 78, Issue 1, Page(s) 35–39

Abstract: Objectives: No study evaluated the contribution of adjunctive surgery in bedaquiline-treated patients. This study describes treatment outcomes and complications in a cohort of drug-resistant pulmonary tuberculosis (TB) cases treated with bedaquiline- ... ...

Abstract	Objectives: No study evaluated the contribution of adjunctive surgery in bedaquiline-treated patients. This study describes treatment outcomes and complications in a cohort of drug-resistant pulmonary tuberculosis (TB) cases treated with bedaquiline-containing regimens undergoing surgery. Methods: This retrospective observational study recruited patients treated for TB in 12 centres in 9 countries between January 2007 and March 2015. Patients who had surgical indications in a bedaquiline-treated programme-based cohort were selected and surgery-related information was collected. Patient characteristics and surgical indications were described together with type of operation, surgical complications, bacteriological conversion rates, and treatment outcomes. Treatment outcomes were evaluated according to the time of surgery. Results: 57 bedaquiline-exposed cases resistant to a median of 7 drugs had indication for surgery (52 retreatments; 50 extensively drug-resistant (XDR) or pre XDR-TB). Sixty percent of cases initiated bedaquiline treatment following surgery, while 36.4% underwent the bedaquiline regimen before surgery and completed it after the operation. At treatment completion 90% culture-converted with 69.1% achieving treatment success; 21.8% had unfavourable outcomes (20.0% treatment failure, 1.8% lost to follow-up), and 9.1% were still undergoing treatment. Conclusions: The study results suggest that bedaquiline and surgery can be safely and effectively combined in selected cases with a specific indication.
MeSH term(s)	Adult ; Antitubercular Agents/therapeutic use ; Coinfection/microbiology ; Coinfection/virology ; Diarylquinolines/therapeutic use ; Female ; HIV Infections/complications ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Surgical Procedures, Operative/statistics & numerical data ; Treatment Outcome ; Tuberculosis, Multidrug-Resistant/drug therapy ; Tuberculosis, Multidrug-Resistant/surgery
Chemical Substances	Antitubercular Agents ; Diarylquinolines ; bedaquiline (78846I289Y)
Language	English
Publishing date	2018-08-07
Publishing country	England
Document type	Journal Article ; Observational Study
ZDB-ID	424417-5
ISSN	1532-2742 ; 0163-4453
ISSN (online)	1532-2742
ISSN	0163-4453
DOI	10.1016/j.jinf.2018.08.003
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Article ; Online: Long-term outcomes of the global tuberculosis and COVID-19 co-infection cohort.

Casco, Nicolas / Jorge, Alberto Levi / Palmero, Domingo Juan / Alffenaar, Jan-Willem / Fox, Greg J / Ezz, Wafaa / Cho, Jin-Gun / Denholm, Justin / Skrahina, Alena / Solodovnikova, Varvara / Arbex, Marcos Abdo / Alves, Tatiana / Rabahi, Marcelo Fouad / Pereira, Giovana Rodrigues / Sales, Roberta / Silva, Denise Rossato / Saffie, Muntasir M / Salinas, Nadia Escobar / Miranda, Ruth Caamaño /

Cisterna, Catalina / Concha, Clorinda / Fernandez, Israel / Villalón, Claudia / Vera, Carolina Guajardo / Tapia, Patricia Gallegos / Cancino, Viviana / Carbonell, Monica / Cruz, Arturo / Muñoz, Eduardo / Muñoz, Camila / Navarro, Indira / Pizarro, Rolando / Cristina Sánchez, Gloria Pereira / Vergara Riquelme, Maria Soledad / Vilca, Evelyn / Soto, Aline / Flores, Ximena / Garavagno, Ana / Bahamondes, Martina Hartwig / Merino, Luis Moyano / Pradenas, Ana María / Revillot, Macarena Espinoza / Rodriguez, Patricia / Salinas, Angeles Serrano / Taiba, Carolina / Valdés, Joaquín Farías / Subiabre, Jorge Navarro / Ortega, Carlos / Palma, Sofia / Castillo, Patricia Perez / Pinto, Mónica / Bidegain, Francisco Rivas / Venegas, Margarita / Yucra, Edith / Li, Yang / Cruz, Andres / Guelvez, Beatriz / Victoria Plaza, Regina / Tello Hoyos, Kelly Yoana / Cardoso-Landivar, José / Van Den Boom, Martin / Andréjak, Claire / Blanc, François-Xavier / Dourmane, Samir / Froissart, Antoine / Izadifar, Armine / Rivière, Frédéric / Schlemmer, Frédéric / Manika, Katerina / Diallo, Boubacar Djelo / Hassane-Harouna, Souleymane / Artiles, Norma / Mejia, Licenciada Andrea / Gupta, Nitesh / Ish, Pranav / Mishra, Gyanshankar / Patel, Jigneshkumar M / Singla, Rupak / Udwadia, Zarir F / Alladio, Francesca / Angeli, Fabio / Calcagno, Andrea / Centis, Rosella / Codecasa, Luigi Ruffo / De Lauretis, Angelo / Esposito, Susanna M R / Formenti, Beatrice / Gaviraghi, Alberto / Giacomet, Vania / Goletti, Delia / Gualano, Gina / Matteelli, Alberto / Migliori, Giovanni Battista / Motta, Ilaria / Palmieri, Fabrizio / Pontali, Emanuele / Prestileo, Tullio / Riccardi, Niccolò / Saderi, Laura / Saporiti, Matteo / Sotgiu, Giovanni / Spanevello, Antonio / Stochino, Claudia / Tadolini, Marina / Torre, Alessandro / Villa, Simone / Visca, Dina / Kurhasani, Xhevat / Furjani, Mohammed / Rasheed, Najia / Danila, Edvardas / Diktanas, Saulius / Ridaura, Ruy López / Luna López, Fátima Leticia / Torrico, Marcela Muñoz / Rendon, Adrian / Akkerman, Onno W / Chizaram, Onyeaghala / Al-Abri, Seif / Alyaquobi, Fatma / Althohli, Khalsa / Aguirre, Sarita / Teixeira, Rosarito Coronel / De Egea, Viviana / Irala, Sandra / Medina, Angélica / Sequera, Guillermo / Sosa, Natalia / Vázquez, Fátima / Llanos-Tejada, Félix K / Manga, Selene / Villanueva-Villegas, Renzo / Araujo, David / Sales Marques, Raquel DuarteTânia / Socaci, Adriana / Barkanova, Olga / Bogorodskaya, Maria / Borisov, Sergey / Mariandyshev, Andrei / Kaluzhenina, Anna / Vukicevic, Tatjana Adzic / Stosic, Maja / Beh, Darius / Ng, Deborah / Ong, Catherine W M / Solovic, Ivan / Dheda, Keertan / Gina, Phindile / Caminero, José A / De Souza Galvão, Maria Luiza / Dominguez-Castellano, Angel / García-García, José-María / Pinargote, Israel Molina / Fernandez, Sarai Quirós / Sánchez-Montalvá, Adrián / Huguet, Eva Tabernero / Murguiondo, Miguel Zabaleta / Bart, Pierre-Alexandre / Mazza-Stalder, Jesica / D'Ambrosio, Lia / Kamolwat, Phalin / Bakko, Freya / Barnacle, James / Bird, Sophie / Brown, Annabel / Chandran, Shruthi / Killington, Kieran / Man, Kathy / Papineni, Padmasayee / Ritchie, Flora / Tiberi, Simon / Utjesanovic, Natasa / Zenner, Dominik / Hearn, Jasie L / Heysell, Scott / Young, Laura

The European respiratory journal

2023 Volume 62, Issue 5

Abstract: Background: Longitudinal cohort data of patients with tuberculosis (TB) and coronavirus disease 2019 (COVID-19) are lacking. In our global study, we describe long-term outcomes of patients affected by TB and COVID-19.: Methods: We collected data from ...

Abstract	Background: Longitudinal cohort data of patients with tuberculosis (TB) and coronavirus disease 2019 (COVID-19) are lacking. In our global study, we describe long-term outcomes of patients affected by TB and COVID-19. Methods: We collected data from 174 centres in 31 countries on all patients affected by COVID-19 and TB between 1 March 2020 and 30 September 2022. Patients were followed-up until cure, death or end of cohort time. All patients had TB and COVID-19; for analysis purposes, deaths were attributed to TB, COVID-19 or both. Survival analysis was performed using Cox proportional risk-regression models, and the log-rank test was used to compare survival and mortality attributed to TB, COVID-19 or both. Results: Overall, 788 patients with COVID-19 and TB (active or sequelae) were recruited from 31 countries, and 10.8% (n=85) died during the observation period. Survival was significantly lower among patients whose death was attributed to TB and COVID-19 Conclusions: In our global cohort, death was the outcome in >10% of patients with TB and COVID-19. A range of demographic and clinical predictors are associated with adverse outcomes.
MeSH term(s)	Humans ; Male ; COVID-19/complications ; HIV Infections/complications ; Coinfection ; Risk Factors ; Tuberculosis, Miliary ; Retrospective Studies
Language	English
Publishing date	2023-11-29
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639359-7
ISSN	1399-3003 ; 0903-1936
ISSN (online)	1399-3003
ISSN	0903-1936
DOI	10.1183/13993003.00925-2023
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Article ; Online: Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report.

Borisov, Sergey / Danila, Edvardas / Maryandyshev, Andrei / Dalcolmo, Margareth / Miliauskas, Skaidrius / Kuksa, Liga / Manga, Selene / Skrahina, Alena / Diktanas, Saulius / Codecasa, Luigi Ruffo / Aleksa, Alena / Bruchfeld, Judith / Koleva, Antoniya / Piubello, Alberto / Udwadia, Zarir Farokh / Akkerman, Onno W / Belilovski, Evgeny / Bernal, Enrique / Boeree, Martin J /

Cadiñanos Loidi, Julen / Cai, Qingshan / Cebrian Gallardo, Jose Joaquín / Dara, Masoud / Davidavičienė, Edita / Forsman, Lina Davies / De Los Rios, Jorge / Denholm, Justin / Drakšienė, Jacinta / Duarte, Raquel / Elamin, Seifeldin Eltaeb / Escobar Salinas, Nadia / Ferrarese, Maurizio / Filippov, Alexey / Garcia, Ana / García-García, José-María / Gaudiesiute, Ieva / Gavazova, Blagovesta / Gayoso, Regina / Gomez Rosso, Roscio / Gruslys, Vygantas / Gualano, Gina / Hoefsloot, Wouter / Jonsson, Jerker / Khimova, Elena / Kunst, Heinke / Laniado-Laborín, Rafael / Li, Yang / Magis-Escurra, Cecile / Manfrin, Vinicio / Marchese, Valentina / Martínez Robles, Elena / Matteelli, Alberto / Mazza-Stalder, Jesica / Moschos, Charalampos / Muñoz-Torrico, Marcela / Mustafa Hamdan, Hamdan / Nakčerienė, Birutė / Nicod, Laurent / Nieto Marcos, Magnolia / Palmero, Domingo Juan / Palmieri, Fabrizio / Papavasileiou, Apostolos / Payen, Marie-Christine / Pontarelli, Agostina / Quirós, Sarai / Rendon, Adrian / Saderi, Laura / Šmite, Agnese / Solovic, Ivan / Souleymane, Mahamadou Bassirou / Tadolini, Marina / van den Boom, Martin / Vescovo, Marisa / Viggiani, Pietro / Yedilbayev, Askar / Zablockis, Rolandas / Zhurkin, Dmitry / Zignol, Matteo / Visca, Dina / Spanevello, Antonio / Caminero, José A / Alffenaar, Jan-Willem / Tiberi, Simon / Centis, Rosella / D'Ambrosio, Lia / Pontali, Emanuele / Sotgiu, Giovanni / Migliori, Giovanni Battista

The European respiratory journal

2019 Volume 54, Issue 6

Abstract: The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.The aim of this prospective study was to evaluate the frequency and ...

Abstract	The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new (
MeSH term(s)	Adult ; Aged ; Antitubercular Agents/adverse effects ; Drug-Related Side Effects and Adverse Reactions/diagnosis ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Female ; Humans ; Male ; Middle Aged ; Pharmacovigilance ; Prospective Studies ; Tuberculosis, Multidrug-Resistant/drug therapy
Chemical Substances	Antitubercular Agents
Language	English
Publishing date	2019-12-19
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639359-7
ISSN	1399-3003 ; 0903-1936
ISSN (online)	1399-3003
ISSN	0903-1936
DOI	10.1183/13993003.01522-2019
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Article ; Online: Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study.

Akkerman, Onno / Aleksa, Alena / Alffenaar, Jan-Willem / Al-Marzouqi, Nada Hassan / Arias-Guillén, Miguel / Belilovski, Evgeny / Bernal, Enrique / Boeree, Martin J / Borisov, Sergey E / Bruchfeld, Judith / Cadiñanos Loidi, Julen / Cai, Qingshan / Caminero, Jose A / Cebrian Gallardo, Jose Joaquín / Centis, Rosella / Codecasa, Luigi Ruffo / D'Ambrosio, Lia / Dalcolmo, Margareth / Danila, Edvardas /

Dara, Masoud / Davidavičienė, Edita / Davies Forsman, Lina / De Los Rios Jefe, Jorge / Denholm, Justin / Duarte, Raquel / Elamin, Seifeldin Eltaeb / Ferrarese, Maurizio / Filippov, Alexey / Ganatra, Shashank / Garcia, Ana / García-García, José-María / Gayoso, Regina / Giraldo Montoya, Angela Maria / Gomez Rosso, Roscio Gomez / Gualano, Gina / Hoefsloot, Wouter / Ilievska-Poposka, Biljana / Jonsson, Jerker / Khimova, Elena / Kuksa, Liga / Kunst, Heinke / Laniado-Laborín, Rafael / Li, Yang / Magis-Escurra, Cecile / Manfrin, Vinicio / Manga, Selene / Marchese, Valentina / Martínez Robles, Elena / Maryandyshev, Andrei / Matteelli, Alberto / Migliori, Giovanni Battista / Mullerpattan, Jai B / Munoz-Torrico, Marcela / Mustafa Hamdan, Hamdan / Nieto Marcos, Magnolia / Noordin, Noorliza Mohamad / Palmero, Domingo Juan / Palmieri, Fabrizio / Payen, Marie-Christine / Piubello, Alberto / Pontali, Emanuele / Pontarelli, Agostina / Quirós, Sarai / Rendon, Adrian / Skrahina, Alena / Šmite, Agnese / Solovic, Ivan / Sotgiu, Giovanni / Souleymane, Mahamadou Bassirou / Spanevello, Antonio / Stošić, Maja / Tadolini, Marina / Tiberi, Simon / Udwadia, Zarir Farokh / van den Boom, Martin / Vescovo, Marisa / Viggiani, Pietro / Visca, Dina / Zhurkin, Dmitry / Zignol, Matteo

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases

2019 Volume 83, Page(s) 72–76

Abstract: The World Health Organization launched a global initiative, known as aDSM (active TB drug safety monitoring and management) to better describe the safety profile of new treatment regimens for drug-resistant tuberculosis (TB) in real-world settings. ... ...

Abstract	The World Health Organization launched a global initiative, known as aDSM (active TB drug safety monitoring and management) to better describe the safety profile of new treatment regimens for drug-resistant tuberculosis (TB) in real-world settings. However, comprehensive surveillance is difficult to implement in several countries. The aim of the aDSM project is to demonstrate the feasibility of implementing national aDSM registers and to describe the type and the frequency of adverse events (AEs) associated with exposure to the new anti-TB drugs. Following a pilot study carried out in 2016, official involvement of TB reference centres/countries into the project was sought and cases treated with bedaquiline- and/or delamanid-containing regimens were consecutively recruited. AEs were prospectively collected ensuring potential attribution of the AE to a specific drug based on its known safety profile. A total of 309 cases were fully reported from 41 centres in 27 countries (65% males; 268 treated with bedaquiline, 20 with delamanid, and 21 with both drugs) out of an estimated 781 cases the participating countries had committed to report by the first quarter of 2019.
MeSH term(s)	Antitubercular Agents/adverse effects ; Diarylquinolines/administration & dosage ; Diarylquinolines/adverse effects ; Drug Therapy, Combination ; Feasibility Studies ; Female ; Humans ; Male ; Nitroimidazoles/administration & dosage ; Nitroimidazoles/adverse effects ; Oxazoles/administration & dosage ; Oxazoles/adverse effects ; Pilot Projects ; Tuberculosis/drug therapy ; Tuberculosis, Multidrug-Resistant/drug therapy ; World Health Organization
Chemical Substances	Antitubercular Agents ; Diarylquinolines ; Nitroimidazoles ; OPC-67683 ; Oxazoles ; bedaquiline (78846I289Y)
Language	English
Publishing date	2019-04-03
Publishing country	Canada
Document type	Journal Article
ZDB-ID	1331197-9
ISSN	1878-3511 ; 1201-9712
ISSN (online)	1878-3511
ISSN	1201-9712
DOI	10.1016/j.ijid.2019.03.036
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Article ; Online: Effectiveness and safety of bedaquiline-containing regimens in the treatment of MDR- and XDR-TB: a multicentre study.

Borisov, Sergey E / Dheda, Keertan / Enwerem, Martin / Romero Leyet, Rodolfo / D'Ambrosio, Lia / Centis, Rosella / Sotgiu, Giovanni / Tiberi, Simon / Alffenaar, Jan-Willem / Maryandyshev, Andrey / Belilovski, Evgeny / Ganatra, Shashank / Skrahina, Alena / Akkerman, Onno / Aleksa, Alena / Amale, Rohit / Artsukevich, Janina / Bruchfeld, Judith / Caminero, Jose A /

Carpena Martinez, Isabel / Codecasa, Luigi / Dalcolmo, Margareth / Denholm, Justin / Douglas, Paul / Duarte, Raquel / Esmail, Aliasgar / Fadul, Mohammed / Filippov, Alexey / Davies Forsman, Lina / Gaga, Mina / Garcia-Fuertes, Julia-Amaranta / García-García, José-María / Gualano, Gina / Jonsson, Jerker / Kunst, Heinke / Lau, Jillian S / Lazaro Mastrapa, Barbara / Teran Troya, Jorge Lazaro / Manga, Selene / Manika, Katerina / González Montaner, Pablo / Mullerpattan, Jai / Oelofse, Suzette / Ortelli, Martina / Palmero, Domingo Juan / Palmieri, Fabrizio / Papalia, Antonella / Papavasileiou, Apostolos / Payen, Marie-Christine / Pontali, Emanuele / Robalo Cordeiro, Carlos / Saderi, Laura / Sadutshang, Tsetan Dorji / Sanukevich, Tatsiana / Solodovnikova, Varvara / Spanevello, Antonio / Topgyal, Sonam / Toscanini, Federica / Tramontana, Adrian R / Udwadia, Zarir Farokh / Viggiani, Pietro / White, Veronica / Zumla, Alimuddin / Migliori, Giovanni Battista

The European respiratory journal

2017 Volume 49, Issue 5

Abstract: Large studies on bedaquiline used to treat multidrug-resistant (MDR-) and extensively drug-resistant tuberculosis (XDR-TB) are lacking. This study aimed to evaluate the safety and effectiveness of bedaquiline-containing regimens in a large, retrospective, ...

Abstract	Large studies on bedaquiline used to treat multidrug-resistant (MDR-) and extensively drug-resistant tuberculosis (XDR-TB) are lacking. This study aimed to evaluate the safety and effectiveness of bedaquiline-containing regimens in a large, retrospective, observational study conducted in 25 centres and 15 countries in five continents.428 culture-confirmed MDR-TB cases were analysed (61.5% male; 22.1% HIV-positive, 45.6% XDR-TB). MDR-TB cases were admitted to hospital for a median (interquartile range (IQR)) 179 (92-280) days and exposed to bedaquiline for 168 (86-180) days. Treatment regimens included, among others, linezolid, moxifloxacin, clofazimine and carbapenems (82.0%, 58.4%, 52.6% and 15.3% of cases, respectively).Sputum smear and culture conversion rates in MDR-TB cases were 63.6% and 30.1%, respectively at 30 days, 81.1% and 56.7%, respectively at 60 days; 85.5% and 80.5%, respectively at 90 days and 88.7% and 91.2%, respectively at the end of treatment. The median (IQR) time to smear and culture conversion was 34 (30-60) days and 60 (33-90) days. Out of 247 culture-confirmed MDR-TB cases completing treatment, 71.3% achieved success (62.4% cured; 8.9% completed treatment), 13.4% died, 7.3% defaulted and 7.7% failed. Bedaquiline was interrupted due to adverse events in 5.8% of cases. A single case died, having electrocardiographic abnormalities that were probably non-bedaquiline related.Bedaquiline-containing regimens achieved high conversion and success rates under different nonexperimental conditions.
MeSH term(s)	Adult ; Antitubercular Agents/therapeutic use ; Carbapenems/therapeutic use ; Clofazimine/therapeutic use ; Cohort Studies ; Diarylquinolines/therapeutic use ; Drug Therapy, Combination ; Extensively Drug-Resistant Tuberculosis/drug therapy ; Female ; HIV Infections/complications ; Humans ; Linezolid/therapeutic use ; Male ; Middle Aged ; Patient Safety ; Retrospective Studies ; Sputum/metabolism ; Treatment Outcome ; Tuberculosis, Multidrug-Resistant/drug therapy
Chemical Substances	Antitubercular Agents ; Carbapenems ; Diarylquinolines ; bedaquiline (78846I289Y) ; Clofazimine (D959AE5USF) ; Linezolid (ISQ9I6J12J)
Language	English
Publishing date	2017
Publishing country	England
Document type	Journal Article ; Multicenter Study
ZDB-ID	639359-7
ISSN	1399-3003 ; 0903-1936
ISSN (online)	1399-3003
ISSN	0903-1936
DOI	10.1183/13993003.00387-2017
Database	MEDical Literature Analysis and Retrieval System OnLINE

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