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5 results on '"Manga, S."'

1. Outcome of treatment of MDR-TB or drug-resistant patients treated with bedaquiline and delamanid: Results from a large global cohort.

Author

Koirala S, Borisov S, Danila E, Mariandyshev A, Shrestha B, Lukhele N, Dalcolmo M, Shakya SR, Miliauskas S, Kuksa L, Manga S, Aleksa A, Denholm JT, Khadka HB, Skrahina A, Diktanas S, Ferrarese M, Bruchfeld J, Koleva A, Piubello A, Koirala GS, Udwadia ZF, Palmero DJ, Munoz-Torrico M, Gc R, Gualano G, Grecu VI, Motta I, Papavasileiou A, Li Y, Hoefsloot W, Kunst H, Mazza-Stalder J, Payen MC, Akkerman OW, Bernal E, Manfrin V, Matteelli A, Mustafa Hamdan H, Nieto Marcos M, Cadiñanos Loidi J, Cebrian Gallardo JJ, Duarte R, Escobar Salinas N, Gomez Rosso R, Laniado-Laborín R, Martínez Robles E, Quirós Fernandez S, Rendon A, Solovic I, Tadolini M, Viggiani P, Belilovski E, Boeree MJ, Cai Q, Davidavičienė E, Forsman LD, De Los Rios J, Drakšienė J, Duga A, Elamin SE, Filippov A, Garcia A, Gaudiesiute I, Gavazova B, Gayoso R, Gruslys V, Jonsson J, Khimova E, Madonsela G, Magis-Escurra C, Marchese V, Matei M, Moschos C, Nakčerienė B, Nicod L, Palmieri F, Pontarelli A, Šmite A, Souleymane MB, Vescovo M, Zablockis R, Zhurkin D, Alffenaar JW, Caminero JA, Codecasa LR, García-García JM, Esposito S, Saderi L, Spanevello A, Visca D, Tiberi S, Pontali E, Centis R, D'Ambrosio L, van den Boom M, Sotgiu G, and Migliori GB

Subjects
Adult, Female, Humans, Male, Middle Aged, Prospective Studies, Treatment Outcome, Tuberculosis, Multidrug-Resistant drug therapy, Antitubercular Agents therapeutic use, Diarylquinolines therapeutic use, Nitroimidazoles therapeutic use, Oxazoles therapeutic use, Tuberculosis, Multidrug-Resistant epidemiology
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., (Copyright © 2021 Sociedade Portuguesa de Pneumologia. Published by Elsevier España, S.L.U. All rights reserved.)

Published
2021
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2. Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study.

Author

Akkerman O, Aleksa A, Alffenaar JW, Al-Marzouqi NH, Arias-Guillén M, Belilovski E, Bernal E, Boeree MJ, Borisov SE, Bruchfeld J, Cadiñanos Loidi J, Cai Q, Caminero JA, Cebrian Gallardo JJ, Centis R, Codecasa LR, D'Ambrosio L, Dalcolmo M, Danila E, Dara M, Davidavičienė E, Davies Forsman L, De Los Rios Jefe J, Denholm J, Duarte R, Elamin SE, Ferrarese M, Filippov A, Ganatra S, Garcia A, García-García JM, Gayoso R, Giraldo Montoya AM, Gomez Rosso RG, Gualano G, Hoefsloot W, Ilievska-Poposka B, Jonsson J, Khimova E, Kuksa L, Kunst H, Laniado-Laborín R, Li Y, Magis-Escurra C, Manfrin V, Manga S, Marchese V, Martínez Robles E, Maryandyshev A, Matteelli A, Migliori GB, Mullerpattan JB, Munoz-Torrico M, Mustafa Hamdan H, Nieto Marcos M, Noordin NM, Palmero DJ, Palmieri F, Payen MC, Piubello A, Pontali E, Pontarelli A, Quirós S, Rendon A, Skrahina A, Šmite A, Solovic I, Sotgiu G, Souleymane MB, Spanevello A, Stošić M, Tadolini M, Tiberi S, Udwadia ZF, van den Boom M, Vescovo M, Viggiani P, Visca D, Zhurkin D, and Zignol M

Subjects
Diarylquinolines administration & dosage, Drug Therapy, Combination, Feasibility Studies, Female, Humans, Male, Nitroimidazoles administration & dosage, Oxazoles administration & dosage, Pilot Projects, Tuberculosis drug therapy, World Health Organization, Antitubercular Agents adverse effects, Diarylquinolines adverse effects, Nitroimidazoles adverse effects, Oxazoles adverse effects, Tuberculosis, Multidrug-Resistant drug therapy
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., (Copyright © 2019. Published by Elsevier Ltd.)

Published
2019
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3. Outcomes of patients with drug-resistant-tuberculosis treated with bedaquiline-containing regimens and undergoing adjunctive surgery.

Author

Borisov SE, D'Ambrosio L, Centis R, Tiberi S, Dheda K, Alffenaar JW, Amale R, Belilowski E, Bruchfeld J, Canneto B, Denholm J, Duarte R, Esmail A, Filippov A, Davies Forsman L, Gaga M, Ganatra S, Igorevna GA, Lazaro Mastrapa B, Manfrin V, Manga S, Maryandyshev A, Massard G, González Montaner P, Mullerpattan J, Palmero DJ, Pontarelli A, Papavasileiou A, Pontali E, Romero Leyet R, Spanevello A, Udwadia ZF, Viggiani P, Visca D, Sotgiu G, and Migliori GB

Subjects
Adult, Coinfection microbiology, Coinfection virology, Female, HIV Infections complications, Humans, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Tuberculosis, Multidrug-Resistant surgery, Antitubercular Agents therapeutic use, Diarylquinolines therapeutic use, Surgical Procedures, Operative statistics & numerical data, Tuberculosis, Multidrug-Resistant drug therapy
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., (Copyright © 2018 The British Infection Association. Published by Elsevier Ltd. All rights reserved.)

Published
2019
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4. Effectiveness and safety of bedaquiline-containing regimens in the treatment of MDR- and XDR-TB: a multicentre study.

Author

Borisov SE, Dheda K, Enwerem M, Romero Leyet R, D'Ambrosio L, Centis R, Sotgiu G, Tiberi S, Alffenaar JW, Maryandyshev A, Belilovski E, Ganatra S, Skrahina A, Akkerman O, Aleksa A, Amale R, Artsukevich J, Bruchfeld J, Caminero JA, Carpena Martinez I, Codecasa L, Dalcolmo M, Denholm J, Douglas P, Duarte R, Esmail A, Fadul M, Filippov A, Davies Forsman L, Gaga M, Garcia-Fuertes JA, García-García JM, Gualano G, Jonsson J, Kunst H, Lau JS, Lazaro Mastrapa B, Teran Troya JL, Manga S, Manika K, González Montaner P, Mullerpattan J, Oelofse S, Ortelli M, Palmero DJ, Palmieri F, Papalia A, Papavasileiou A, Payen MC, Pontali E, Robalo Cordeiro C, Saderi L, Sadutshang TD, Sanukevich T, Solodovnikova V, Spanevello A, Topgyal S, Toscanini F, Tramontana AR, Udwadia ZF, Viggiani P, White V, Zumla A, and Migliori GB

Subjects
Adult, Carbapenems therapeutic use, Clofazimine therapeutic use, Cohort Studies, Drug Therapy, Combination, Female, HIV Infections complications, Humans, Linezolid therapeutic use, Male, Middle Aged, Patient Safety, Retrospective Studies, Sputum metabolism, Treatment Outcome, Antitubercular Agents therapeutic use, Diarylquinolines therapeutic use, Extensively Drug-Resistant Tuberculosis drug therapy, Tuberculosis, Multidrug-Resistant drug therapy
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., Competing Interests: Conflict of interest: Disclosures can be found alongside this article at erj.ersjournals.com, (Copyright ©ERS 2017.)

Published
2017
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5. Should we worry about bedaquiline exposure in the treatment of multidrug-resistant and extensively drug-resistant tuberculosis?

Author

Alffenaar, J. -W. C., Akkerman, O. W., Tiberi, S., Sotgiu, G., Migliori, G. B., Montaner, P. G., Palmero, D. J., Denholm, J., Douglas, P., Lau, J. S., Tramontana, A. R., Aleksa, A., Artsukevich, J., Sanukevich, T., Skrahina, A., Solodovnikova, V., Payen, M. -C., Dalcolmo, M., Gaga, M., Manika, K., Papavasileiou, A., Amale, R., Ganatra, S., Mullerpattan, J., Sadutshang, T. D., Topgyal, S., Udwadia, Z. F., Centis, R., Codecasa, L., D'Ambrosio, L., Gualano, G., Palmieri, F., Papalia, A., Pontali, E., Saderi, L., Spanevello, A., Toscanini, F., Viggiani, P., Manga, S., Duarte, R., Cordeiro, C. R., Belilovski, E., Borisov, S. E., Filippov, A., Maryandyshev, A., Dheda, K., Enwerem, M., Esmail, A., Fadul, M., Mastrapa, B. L., Teran Troya, J. L., Oelofse, S., Leyet, R. R., Caminero, J. A., Garcia-Garcia, J. -M., Garcia-Fuertes, J. -A., Martinez, I. C., Bruchfeld, J., Forsman, L. D., Jonsson, J., Kunst, H., White, V., and Zumla, A.

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Standard of care, media_common.quotation_subject, Extensively Drug-Resistant Tuberculosis, Antitubercular Agents, World health, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Nothing, Tuberculosis, Multidrug-Resistant, Medicine, Humans, 030212 general & internal medicine, Diarylquinolines, Intensive care medicine, media_common, business.industry, Conflict of interest, Guideline, Precision medicine, 030228 respiratory system, chemistry, Worry, Bedaquiline, business
Abstract

Recently, the World Health Organization (WHO) released the updated guideline on the treatment for multi-drug resistant tuberculosis (MDR-TB) treatment regimens based on new experimental and observational evidence [1]. In this new guidance the most important drugs are the late-generation fluoroquinolones ( i.e. , levofloxacin and moxifloxacin), linezolid, and bedaquiline. Despite the new guidance MDR- and extensively drug resistant (XDR) TB treatment is challenging due to the risk of drug-related adverse events (AE) and drug-drug interactions (DDI). Precision medicine-based approach to minimise the risk of resistance emergence and amplification and to provide patients with the highest standard of care has been recommended [2]. Footnotes This manuscript has recently been accepted for publication in the European Respiratory Journal . It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article. Conflict of interest: Dr. Alffenaar has nothing to disclose. Conflict of interest: Dr. Akkerman has nothing to disclose. Conflict of interest: Dr. Tiberi has nothing to disclose. Conflict of interest: Dr. Sotgiu has nothing to disclose. Conflict of interest: Dr. Migliori has nothing to disclose.

Published
2019

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