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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, S.R., Miliauskas, S., Kuksa, L., Manga, S., Aleksa, A., Denholm, J.T., Khadka, H.B., Skrahina, A., Diktanas, S., Ferrarese, M., Bruchfeld, J., Koleva, A., Piubello, A., Koirala, G.S., Udwadia, Z.F., Palmero, D.J., Munoz-Torrico, M., GC, R., Gualano, G., Grecu, V.I., Motta, I., Papavasileiou, A., Li, Y., Hoefsloot, W., Kunst, H., Mazza-Stalder, J., Payen, M.-C., Akkerman, O.W., Bernal, E., Manfrin, V., Matteelli, A., Mustafa Hamdan, H., Nieto Marcos, M., Cadiñanos Loidi, J., Cebrian Gallardo, J.J., 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, M.J., Cai, Q., Davidavičienė, E., Forsman, L.D., De Los Rios, J., Drakšienė, J., Duga, A., Elamin, S.E., 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, M.B., Vescovo, M., Zablockis, R., Zhurkin, D., Alffenaar, J.-W., Caminero, J.A., Codecasa, L.R., García-García, J.-M., 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, G.B.

Published
2021
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2. MDR/XDR-TB management of patients and contacts: Challenges facing the new decade. The 2020 clinical update by the Global Tuberculosis Network

Author

Arkub, T. Abu, Akkerman, O.W., Aleksa, A., Belilovski, E., Bernal, E., Blanc, F-X., Boeree, M., Borisov, S., Bruchfeld, J., Cadiñanos Loidi, J., Caminero, J.A., Carvalho, A.C., Cebrian Gallardo, J.J., Charalampos, Danila, E., Davies Forsman, L., Denholm, J., Dheda, K., Diel, R., Diktanas, S., Dobler, C., Enwerem, M., Esposito, S., Escobar Salinas, N., Filippov, A., Formenti, B., García García, J.M., Goletti, D., Gomez Rosso, R., Gualano, G., Isaakidis, P., Kaluzhenina, A., Koirala, S., Kuksa, L., Kunst, H., Li, Y., Magis-Escurra, C., Manfrin, V., Manga, S., Manika, K., Marchese, V., Martínez Robles, E., Maryandyshev, A., Matteelli, A., Mariani, A., Mazza-Stalder, J., Mello, F., Mendoza, L., Mesi, A., Miliauskas, S., Mustafa Hamdan, H., Ndjeka, N., Nieto Marcos, M., Ottenhoff, T.H.M., Palmero, D.J., Palmieri, F., Papavasileiou, A., Payen, M.C., Pontarelli, A., Pretti Dalcolmo, M., Quirós Fernandez, S., Romero, R., Rossato Silva, D., Santos, A.P., Seaworth, B., Sinitsyn, M., Skrahina, A., Solovic, I., Spanevello, A., Tadolini, M., Torres, C., Udwadia, Z., van den Boom, M., Volchenkov, G.V., Yedilbayev, A., Zaleskis, R., Zellweger, J.P., Migliori, Giovanni Battista, Tiberi, Simon, Zumla, Alimuddin, Petersen, Eskild, Chakaya, Jeremiah Muhwa, Wejse, Christian, Muñoz Torrico, Marcela, Duarte, Raquel, Alffenaar, Jan Willem, Schaaf, H. Simon, Marais, Ben J., Cirillo, Daniela Maria, Alagna, Riccardo, Rendon, Adrian, Pontali, Emanuele, Piubello, Alberto, Figueroa, José, Ferlazzo, Gabriella, García-Basteiro, Alberto, Centis, Rosella, Visca, Dina, D’Ambrosio, Lia, and Sotgiu, Giovanni

Published
2020
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3. 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, V, Motta, I, Papavasileiou, A, Li, Y, Hoefsloot, W, Kunst, H, Mazza-Stalder, J, Payen, M-C, Akkerman, OW, Bernal, E, Manfrin, V, Matteelli, A, Hamdan, HM, Marcos, MN, Cadinanos Loidi, J, Cebrian Gallardo, JJ, Duarte, R, Escobar Salinas, N, Gomez Rosso, R, Laniado-Laborin, R, Martinez Robles, E, Quiros Fernandez, S, Rendon, A, Solovic, I, Tadolini, M, Viggiani, P, Belilovski, E, Boeree, MJ, Cai, Q, Davidaviciene, E, Forsman, LD, De Los Rios, J, Draksiene, 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, Nakceriene, B, Nicod, L, Palmieri, F, Pontarelli, A, Smite, A, Souleymane, MB, Vescovo, M, Zablockis, R, Zhurkin, D, Alffenaar, J-W, Caminero, JA, Codecasa, LR, Garcia-Garcia, J-M, Esposito, S, Saderi, L, Spanevello, A, Visca, D, Tiberi, S, Pontali, E, Centis, R, D'Ambrosio, L, van den Boom, M, Sotgiuw, G, Migliori, GB, 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, V, Motta, I, Papavasileiou, A, Li, Y, Hoefsloot, W, Kunst, H, Mazza-Stalder, J, Payen, M-C, Akkerman, OW, Bernal, E, Manfrin, V, Matteelli, A, Hamdan, HM, Marcos, MN, Cadinanos Loidi, J, Cebrian Gallardo, JJ, Duarte, R, Escobar Salinas, N, Gomez Rosso, R, Laniado-Laborin, R, Martinez Robles, E, Quiros Fernandez, S, Rendon, A, Solovic, I, Tadolini, M, Viggiani, P, Belilovski, E, Boeree, MJ, Cai, Q, Davidaviciene, E, Forsman, LD, De Los Rios, J, Draksiene, 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, Nakceriene, B, Nicod, L, Palmieri, F, Pontarelli, A, Smite, A, Souleymane, MB, Vescovo, M, Zablockis, R, Zhurkin, D, Alffenaar, J-W, Caminero, JA, Codecasa, LR, Garcia-Garcia, J-M, Esposito, S, Saderi, L, Spanevello, A, Visca, D, Tiberi, S, Pontali, E, Centis, R, D'Ambrosio, L, van den Boom, M, Sotgiuw, G, and Migliori, GB

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.

Published
2021

4. 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

5. Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report

Author

Borisov, S., Danila, E., Maryandyshev, A., Dalcolmo, M., Miliauskas, S., Kuksa, L., Manga, S., Skrahina, A., Diktanas, S., Codecasa, L.R., Aleksa, A., Bruchfeld, J., Koleva, A., Piubello, A., Udwadia, Z.F., Akkerman, O.W., Belilovski, E., Bernal, E., Boeree, M.J., Loidi, J., Cai, Q., Gallardo, J.J. Cebrian, Dara, M., Davidaviciene, E., Forsman, L.D., Rios, J. De Los, Denholm, J., Draksiene, J., Duarte, R., Elamin, S.E., Salinas, N. Escobar, Ferrarese, M., Filippov, A., Garcia, A., Garcia-Garcia, J.M., Gaudiesiute, I., Gavazova, B., Gayoso, R., Rosso, R., Gruslys, V., Gualano, G., Hoefsloot, W., Jonsson, J., Khimova, E., Kunst, H., Laniado-Laborin, R., Li, Y, Magis-Escurra, C., Manfrin, V., Marchese, V., Robles, E. Martinez, Matteelli, A., Mazza-Stalder, J., Moschos, C., Munoz-Torrico, M., Hamdan, H. Mustafa, Nakceriene, B., Nicod, L., Marcos, M., Palmero, D.J., Palmieri, F., Papavasileiou, A., Payen, M.C., Pontarelli, A., Quiros, S., Rendon, A., Saderi, L., Smite, A., Solovic, I., Souleymane, M.B., Tadolini, M., Boom, M. van den, Vescovo, M., Viggiani, P., Yedilbayev, A., Zablockis, R., Zhurkin, D., Zignol, M., Visca, D., Spanevello, A., Caminero, J.A., Alffenaar, J.W.C., Tiberi, S., Centis, R., D'Ambrosio, L., Pontali, E., Sotgiu, G., Migliori, G.B., Borisov, S., Danila, E., Maryandyshev, A., Dalcolmo, M., Miliauskas, S., Kuksa, L., Manga, S., Skrahina, A., Diktanas, S., Codecasa, L.R., Aleksa, A., Bruchfeld, J., Koleva, A., Piubello, A., Udwadia, Z.F., Akkerman, O.W., Belilovski, E., Bernal, E., Boeree, M.J., Loidi, J., Cai, Q., Gallardo, J.J. Cebrian, Dara, M., Davidaviciene, E., Forsman, L.D., Rios, J. De Los, Denholm, J., Draksiene, J., Duarte, R., Elamin, S.E., Salinas, N. Escobar, Ferrarese, M., Filippov, A., Garcia, A., Garcia-Garcia, J.M., Gaudiesiute, I., Gavazova, B., Gayoso, R., Rosso, R., Gruslys, V., Gualano, G., Hoefsloot, W., Jonsson, J., Khimova, E., Kunst, H., Laniado-Laborin, R., Li, Y, Magis-Escurra, C., Manfrin, V., Marchese, V., Robles, E. Martinez, Matteelli, A., Mazza-Stalder, J., Moschos, C., Munoz-Torrico, M., Hamdan, H. Mustafa, Nakceriene, B., Nicod, L., Marcos, M., Palmero, D.J., Palmieri, F., Papavasileiou, A., Payen, M.C., Pontarelli, A., Quiros, S., Rendon, A., Saderi, L., Smite, A., Solovic, I., Souleymane, M.B., Tadolini, M., Boom, M. van den, Vescovo, M., Viggiani, P., Yedilbayev, A., Zablockis, R., Zhurkin, D., Zignol, M., Visca, D., Spanevello, A., Caminero, J.A., Alffenaar, J.W.C., Tiberi, S., Centis, R., D'Ambrosio, L., Pontali, E., Sotgiu, G., and Migliori, G.B.

Abstract

Item does not contain fulltext, 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 (i.e. bedaquiline, delamanid) and repurposed (i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1-2) and 57 (11.3%) as serious (grade 3-5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care.

Published
2019

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

Author

Akkerman, O., Aleksa, A., Alffenaar, J.W.C., Al-Marzouqi, N.H., Arias-Guillen, M., Belilovski, E., Bernal, E., Boeree, M.J., Borisov, S.E., Bruchfeld, J., Loidi, J., Cai, Q., Caminero, J.A., Gallardo, J.J. Cebrian, Centis, R., Codecasa, L.R., D'Ambrosio, L., Dalcolmo, M., Danila, E., Dara, M., Davidaviciene, E., Forsman, L. Davies, Jefe, J. De Los Rios, Denholm, J., Duarte, R., Elamin, S.E., Ferrarese, M., Filippov, A., Ganatra, S., Garcia, A., Garcia-Garcia, J.M., Gayoso, R., Montoya, A.M. Giraldo, Rosso, R.G. Gomez, Gualano, G., Hoefsloot, W., Ilievska-Poposka, B., Jonsson, J., Khimova, E., Kuksa, L., Kunst, H., Laniado-Laborin, R., Li, Y., Magis-Escurra, C., Manfrin, V., Manga, S., Marchese, V., Robles, E. Martinez, Maryandyshev, A., Matteelli, A., Migliori, G.B., Mullerpattan, J.B., Munoz-Torrico, M., Hamdan, H. Mustafa, Marcos, M., Noordin, N.M., Palmero, D.J., Palmieri, F., Payen, M.C., Piubello, A., Pontali, E., Pontarelli, A., Quiros, S., Rendon, A., Skrahina, A., Smite, A., Solovic, I., Sotgiu, G., Souleymane, M.B., Spanevello, A., Stosic, M., Tadolini, M., Tiberi, S., Udwadia, Z.F., Boom, M. van den, Vescovo, M., Viggiani, P., Visca, D., Zhurkin, D., Zignol, M., Akkerman, O., Aleksa, A., Alffenaar, J.W.C., Al-Marzouqi, N.H., Arias-Guillen, M., Belilovski, E., Bernal, E., Boeree, M.J., Borisov, S.E., Bruchfeld, J., Loidi, J., Cai, Q., Caminero, J.A., Gallardo, J.J. Cebrian, Centis, R., Codecasa, L.R., D'Ambrosio, L., Dalcolmo, M., Danila, E., Dara, M., Davidaviciene, E., Forsman, L. Davies, Jefe, J. De Los Rios, Denholm, J., Duarte, R., Elamin, S.E., Ferrarese, M., Filippov, A., Ganatra, S., Garcia, A., Garcia-Garcia, J.M., Gayoso, R., Montoya, A.M. Giraldo, Rosso, R.G. Gomez, Gualano, G., Hoefsloot, W., Ilievska-Poposka, B., Jonsson, J., Khimova, E., Kuksa, L., Kunst, H., Laniado-Laborin, R., Li, Y., Magis-Escurra, C., Manfrin, V., Manga, S., Marchese, V., Robles, E. Martinez, Maryandyshev, A., Matteelli, A., Migliori, G.B., Mullerpattan, J.B., Munoz-Torrico, M., Hamdan, H. Mustafa, Marcos, M., Noordin, N.M., Palmero, D.J., Palmieri, F., Payen, M.C., Piubello, A., Pontali, E., Pontarelli, A., Quiros, S., Rendon, A., Skrahina, A., Smite, A., Solovic, I., Sotgiu, G., Souleymane, M.B., Spanevello, A., Stosic, M., Tadolini, M., Tiberi, S., Udwadia, Z.F., Boom, M. van den, Vescovo, M., Viggiani, P., Visca, D., Zhurkin, D., and Zignol, M.

Abstract

Contains fulltext : 207083.pdf (publisher's version ) (Open Access), 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.

Published
2019

7. Active tuberculosis, sequelae and COVID-19 co-infection: first cohort of 49 cases

Author

Elena Sumarokova, Gina Gualano, Evgeny Belilovski, Armine Izadifar, Eva Tabernero, Pierre Bachez, Alessandro Torre, Maria Luiza de Souza-Galvão, François-Xavier Blanc, Claire Andrejak, Mathilde Fréchet Jachym, Denise Rossato Silva, Paolo Scarpellini, Margarita Marín Royo, Dina Visca, Ángel Domínguez-Castellano, Teresa Rodrigo, Antoine Froissart, Damien Le Dû, Giovanni Sotgiu, Antonio Spanevello, Pierre-Alexandre Bart, Simon Tiberi, Miguel Zabaleta Murguiondo, Frédéric Schlemmer, Marina Tadolini, Rosella Centis, Matteo Saporiti, Sergey Borisov, Giovanni Battista Migliori, Vania Giacomet, Delia Goletti, Frédéric Rivière, Ilaria Motta, Samir Dourmane, Soazic Grard, José Cardoso-Landivar, José-María García-García, Jesica Mazza-Stalder, Fabrizio Palmieri, Luigi Codecasa, Catherine W.M. Ong, Adrián Sánchez-Montalvá, Lia D'Ambrosio, Jan-Willem C. Alffenaar, Paul A. Tambyah, Tadolini M., Codecasa L.R., Garcia-Garcia J.-M., Blanc F.-X., Borisov S., Alffenaar J.-W., Andrejak C., Bachez P., Bart P.-A., Belilovski E., Cardoso-Landivar J., Centis R., D'Ambrosio L., De Souza-Galvao M.-L., Dominguez-Castellano A., Dourmane S., Jachym M.F., Froissart A., Giacomet V., Goletti D., Grard S., Gualano G., Izadifar A., Le Du D., Royo M.M., Mazza-Stalder J., Motta I., Min Ong C.W., Palmieri F., Riviere F., Rodrigo T., Silva D.R., Sanchez-Montalva A., Saporiti M., Scarpellini P., Schlemmer F., Spanevello A., Sumarokova E., Tabernero E., Tambyah P.A., Tiberi S., Torre A., Visca D., Murguiondo M.Z., Sotgiu G., Migliori G.B., Centre hospitalier universitaire de Nantes (CHU Nantes), University Medical Center Groningen [Groningen] (UMCG), CHU Amiens-Picardie, Agents infectieux, résistance et chimiothérapie - UR UPJV 4294 (AGIR ), Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie, CHU Henri Mondor, Centre Hospitalier Intercommunal de Créteil (CHIC), Istituto Nazionale di Malattie Infettive 'Lazzaro Spallanzani' (INMI), Service de pneumologie [Centre Hospitalier Lyon Sud - HCL], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Hôpital Raymond Poincaré [AP-HP], Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), Institut de Biologie Intégrative de la Cellule (I2BC), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay-Centre National de la Recherche Scientifique (CNRS), Maturation des proteines, destinée cellulaire et thérapeutique (PROMTI), Département Biologie des Génomes (DBG), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay-Centre National de la Recherche Scientifique (CNRS)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay-Centre National de la Recherche Scientifique (CNRS)-Institut de Biologie Intégrative de la Cellule (I2BC), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay-Centre National de la Recherche Scientifique (CNRS)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay-Centre National de la Recherche Scientifique (CNRS), Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Aristotle University of Thessaloniki, [Tadolini,m] Unit of Infectious Diseases, Dept of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy. [Codecasa,LR, Saporiti,M] TB Reference Centre, Villa Marelli Institute, Niguarda Hospital, Milan, Italy. [García-García,JM, Rodrigo,T]Tuberculosis Research Programme (PII-TB), SEPAR, Barcelona, Spain. [Blanc,FX] Centre Hospitalier Universitaire, Nantes, France. [Borisov,S, Belilovski,E, Sumarokova,E] Moscow Research and Clinical Center for TB Control, Moscow, Russian Federation. [Alffenaar,JW] The University of Sydney, Sydney Pharmacy School, Sydney, Australia. [Alffenaar,JW] Westmead Hospital, Sydney, Australia. [Alffenaar,JW] Marie Bashir Institute of Infectious Diseases and Biosecurity, University of Sydney, Sydney, Australia. [Andréjak,C] Service de Pneumologie CHU AMIENS PICARDIE, France AND UR Université de Picardie Jules Verne, Amiens, France. [Bachez,P] Service de Pneumologie, Clinique Saint Luc, Bouge, Belgium. [Bart,PA] Dept of Internal Medicine, Lausanne University, Lausanne, Switzerland. [Cardoso-Landivar,J] Servicio Neumología, Vall D´Hebron University Hospital, Barcelona, Spain. [Centis,R] Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy. [D'Ambrosio,L] Public Health Consulting Group, Lugano, Switzerland. [Dominguez-Castellano,A] Servicio de Enfermedades Infecciosas y Microbiología, Hospital Virgen Macarena, Sevilla, Spain. [Dourmane,S] Service de Pneumologie, Groupe hospitalier sud île de France (GHSIF), Melun, France. [Fréchet Jachym,M, Le Du,D] Centre Hospitalier de Bligny, Briis Sous Forges, France. [Froissart,A] Service de Médecine interne, CHI de Créteil, Créteil, France. [Giacomet,V]20Pediatric Infectious Diseases Unit, Dept of Biomedical and Clinical Sciences, L. Sacco Hospital, University of Milan, Milan, Italy. [Goletti,D] Translational Research Unit, National Institute for Infectious Diseases 'L. Spallanzani', IRCCS, Rome, Italy. [Grard,S] Centre de Lutte Antituberculeuse (CLAT 38), Grenoble, France. [Gualano,G, Palmieri,F] Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases 'L. Spallanzani', IRCCS, Rome, Italy. [Izadifar,A] Hôpital Européen de Paris La Roseraie, Aubervilliers, France. [Marín Royo,M] Servicio Neumología, Hospital General Universitario de Castellón, Castelló, Spain. [Mazza-Stalder,J] Pulmonary Division, Lausanne University Hospital CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. [Motta,I] Dipartimento di Scienze Mediche, Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia, Torino, Italia. [Ong,CWM, Tambyah,PA] Dept of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. [Ong,CWM, Tambyah,PA] Institute for Health Innovation and Technology (iHealthtech), National University of Singapore, Singapore. [Rivière,F] Hôpital d'Instruction des Armées (HIA) Percy, Clamart, France. [Silva,DR] Faculdade de Medicina, Universidade Federal do Rio Grande do Sul - UFRGS, Porto Alegre, Brazil. [Sánchez-Montalvá,A]Infectious Diseases Dept, International Health and Tuberculosis Unit, Vall d'Hebron University Hospital, Barcelona, Spain. [Sánchez-Montalvá,A] Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain. [Sánchez-Montalvá,A] Grupo de Estudio de Infecciones por Micobacterias (GEIM), Spanish Society of Infectious Diseases (SEIMC), Spain. [Scarpellini,P] Unit of Infectious Diseases, Università Vita e Salute, San Raffaele Hospital, Milan, Italy. [Schlemmer,F] Hôpitaux Universitaires Henri Mondor, AP-HP, Créteil, France. [Spanevello,A, Visca,D] Division of Pulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy. [Spanevello,A, Visca,D] Dept of Medicine and Surgery, Respiratory Diseases, University of Insubria, Tradate, Italy. [Tabernero,E] Servicio Neumología, Hospital de Cruces, Bilbao, Spain. [Tiberi,S] Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK. [Tiberi,S] Division of Infection, Royal London Hospital, Barts Health NHS Trust, London, UK. [Torre,A] Dept of Infectious Diseases, University of Milan, L. Sacco Hospital, Milan, Italy. [Zabaleta Murguiondo,M] Servicio Neumología Hospital Universitario Marqués de Valdecilla, Santander, Spain. [Sotgiu,G] Clinical Epidemiology and Medical Statistics Unit, Dept of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy. [Migliori,GB] Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy., and CHU Henri Mondor [Créteil]

Subjects
Male, Pediatrics, Adult, Aged, Antitubercular Agents/therapeutic use, Antiviral Agents/therapeutic use, Azithromycin/therapeutic use, Betacoronavirus, Clinical Laboratory Techniques, Cohort Studies, Coinfection, Coronavirus Infections/complications, Coronavirus Infections/diagnosis, Coronavirus Infections/drug therapy, Drug Combinations, Emigrants and Immigrants, Female, Humans, Hydroxychloroquine/therapeutic use, Lopinavir/therapeutic use, Lung/diagnostic imaging, Middle Aged, Mortality, Pandemics, Pneumonia, Viral/complications, Pneumonia, Viral/diagnosis, Pneumonia, Viral/drug therapy, Ritonavir/therapeutic use, Tomography, X-Ray Computed, Tuberculosis/complications, Tuberculosis/diagnosis, Tuberculosis/drug therapy, Tuberculosis, Pulmonary/complications, Tuberculosis, Pulmonary/diagnosis, Tuberculosis, Pulmonary/drug therapy, [SDV]Life Sciences [q-bio], viruses, Antitubercular Agents, Azithromycin, Clinical Laboratory Technique, Lopinavir, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Sequelae, Antitubercular Agent, 0302 clinical medicine, COVID-19 Testing, Health Care::Environment and Public Health::Public Health::Epidemiologic Measurements::Demography [Medical Subject Headings], Drug Combination, 030212 general & internal medicine, Viral, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques [Medical Subject Headings], Lung, Tomography, ComputingMilieux_MISCELLANEOUS, Health Care::Environment and Public Health::Public Health::Epidemiologic Measurements::Demography::Vital Statistics::Mortality [Medical Subject Headings], virus diseases, Pulmonary, respiratory system, X-Ray Computed, Impactos en la salud, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Imaging::Tomography [Medical Subject Headings], Cohort, Coronavirus Infections, medicine.drug, Cohort study, Human, Hydroxychloroquine, Impacts on health, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Tuberculosis, Tuberculosi, Infecciones por coronavirus, Estudios de cohortes, Pneumonia, Viral, Antiviral Agents, Diseases::Bacterial Infections and Mycoses::Bacterial Infections::Gram-Positive Bacterial Infections::Actinomycetales Infections::Mycobacterium Infections::Tuberculosis [Medical Subject Headings], 03 medical and health sciences, Tuberculosis diagnosis, medicine, Research Letter, Tuberculosis, Pulmonary, Secuelas, Ritonavir, Antiviral Agent, Pandemia, Betacoronaviru, Pandemic, business.industry, Coronavirus Infection, SARS-CoV-2, COVID-19, Emigrants and Immigrant, Pneumonia, Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial Agents::Antitubercular Agents [Medical Subject Headings], medicine.disease, Diseases::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [Medical Subject Headings], COVID-19 Drug Treatment, Coronavirus, 030228 respiratory system, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies [Medical Subject Headings], Cohort Studie, business
Abstract

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19) pandemic has attracted interest because of its global rapid spread, clinical severity, high mortality rate, and capacity to overwhelm healthcare systems [1, 2]. SARS-CoV-2 transmission occurs mainly through droplets, although surface contamination contributes and debate continues on aerosol transmission [3–5].

Published
2020
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8. Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report

Author

José-María García-García, Jerker Jonsson, Fabrizio Palmieri, Luigi Codecasa, Matteo Zignol, Andrei Maryandyshev, Qingshan Cai, Domingo Palmero, Magnolia Nieto Marcos, Seifeldin Eltaeb Elamin, Enrique Bernal, Simon Tiberi, Alberto Matteelli, Marisa Vescovo, Judith Bruchfeld, Edita Davidavičienė, Saulius Diktanas, Skaidrius Miliauskas, Rolandas Zablockis, Raquel Duarte, R. Rosso, Martin J. Boeree, Marcela Muñoz-Torrico, Valentina Marchese, Adrian Rendon, Evgeny Belilovski, Sergey Borisov, Zarir F Udwadia, Antoniya Koleva, Jorge De Los Rios, Giovanni Battista Migliori, Ana Garcia, Elena Martínez Robles, Hamdan Mustafa Hamdan, Vygantas Gruslys, Marina Tadolini, Laurent P. Nicod, Laura Saderi, Alena Aleksa, Mahamadou Bassirou Souleymane, Rafael Laniado-Laborín, Vinicio Manfrin, Jesica Mazza-Stalder, Alberto Piubello, Charalampos Moschos, Liga Kuksa, Alexey Filippov, Giovanni Sotgiu, Lia D'Ambrosio, Agostina Pontarelli, Heinke Kunst, Pietro Viggiani, Jan-Willem C. Alffenaar, Emanuele Pontali, Maurizio Ferrarese, Regina Gayoso, Ieva Gaudiesiute, Onno W. Akkerman, Agnese Šmite, Edvardas Danila, Marie-Christine Payen, Justin T Denholm, Jacinta Drakšienė, Blagovesta Gavazova, Wouter Hoefsloot, Elena Khimova, Dina Visca, Askar Yedilbayev, Nadia Escobar Salinas, Julen Cadiñanos Loidi, Sarai Quirós, Ivan Solovic, Jose A. Caminero, Margareth Pretti Dalcolmo, Apostolos Papavasileiou, Gina Gualano, Birutė Nakčerienė, Martin van den Boom, Lina Davies Forsman, Dmitry Zhurkin, Yang Li, Alena Skrahina, Antonio Spanevello, Cecile Magis-Escurra, Masoud Dara, Selene Manga, Jose Joaquin Cebrian Gallardo, Rosella Centis, Microbes in Health and Disease (MHD), Borisov S., Danila E., Maryandyshev A., Dalcolmo M., Miliauskas S., Kuksa L., Manga S., Skrahina A., Diktanas S., Codecasa L.R., Aleksa A., Bruchfeld J., Koleva A., Piubello A., Udwadia Z.F., Akkerman O.W., Belilovski E., Bernal E., Boeree M.J., Loidi J.C., Cai Q., Gallardo J.J.C., Dara M., Davidaviciene E., Forsman L.D., de Los Rios J., Denholm J., Draksiene J., Duarte R., Elamin S.E., Salinas N.E., Ferrarese M., Filippov A., Garcia A., Garcia-Garcia J.-M., Gaudiesiute I., Gavazova B., Gayoso R., Rosso R.G., Gruslys V., Gualano G., Hoefsloot W., Jonsson J., Khimova E., Kunst H., Laniado-Laborin R., Li Y., Magis-Escurra C., Manfrin V., Marchese V., Robles E.M., Matteelli A., Mazza-Stalder J., Moschos C., Munoz-Torrico M., Hamdan H.M., Nakceriene B., Nicod L., Marcos M.N., Palmero D.J., Palmieri F., Papavasileiou A., Payen M.-C., Pontarelli A., Quiros S., Rendon A., Saderi L., Smite A., Solovic I., Souleymane M.B., Tadolini M., Boom M.V.D., Vescovo M., Viggiani P., Yedilbayev A., Zablockis R., Zhurkin D., Zignol M., Visca D., Spanevello A., Caminero J.A., Alffenaar J.-W., Tiberi S., Centis R., D'Ambrosio L., Pontali E., Sotgiu G., and Migliori G.B.

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Tuberculosis, Drug-Related Side Effects and Adverse Reactions, Antitubercular Agents, Terizidone, Clofazimine, Antitubercular Agent, Pharmacovigilance, chemistry.chemical_compound, Internal medicine, Tuberculosis, Multidrug-Resistant, medicine, Humans, Prospective Studies, Adverse effect, Aged, business.industry, Middle Aged, medicine.disease, Prospective Studie, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], chemistry, Tolerability, Female, Delamanid, Bedaquiline, Drug-Related Side Effects and Adverse Reaction, business, Human, medicine.drug
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 (i.e. bedaquiline, delamanid) and repurposed (i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1–2) and 57 (11.3%) as serious (grade 3–5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care.

Published
2019
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9. Active tuberculosis, sequelae and COVID-19 co-infection: first cohort of 49 cases.

Author

Tadolini M, Codecasa LR, García-García JM, Blanc FX, Borisov S, Alffenaar JW, Andréjak C, Bachez P, Bart PA, Belilovski E, Cardoso-Landivar J, Centis R, D'Ambrosio L, Luiza De Souza-Galvão M, Dominguez-Castellano A, Dourmane S, Fréchet Jachym M, Froissart A, Giacomet V, Goletti D, Grard S, Gualano G, Izadifar A, Le Du D, Marín Royo M, Mazza-Stalder J, Motta I, Ong CWM, Palmieri F, Rivière F, Rodrigo T, Silva DR, Sánchez-Montalvá A, Saporiti M, Scarpellini P, Schlemmer F, Spanevello A, Sumarokova E, Tabernero E, Tambyah PA, Tiberi S, Torre A, Visca D, Zabaleta Murguiondo M, Sotgiu G, and Migliori GB

Subjects
Adult, Aged, Antitubercular Agents therapeutic use, Antiviral Agents therapeutic use, Azithromycin therapeutic use, Betacoronavirus, COVID-19, COVID-19 Testing, Clinical Laboratory Techniques, Cohort Studies, Coinfection, Coronavirus Infections diagnosis, Coronavirus Infections drug therapy, Drug Combinations, Emigrants and Immigrants, Female, Humans, Hydroxychloroquine therapeutic use, Lopinavir therapeutic use, Lung diagnostic imaging, Male, Middle Aged, Mortality, Pandemics, Pneumonia, Viral diagnosis, Pneumonia, Viral drug therapy, Ritonavir therapeutic use, SARS-CoV-2, Tomography, X-Ray Computed, Tuberculosis complications, Tuberculosis diagnosis, Tuberculosis drug therapy, Tuberculosis, Pulmonary diagnosis, Tuberculosis, Pulmonary drug therapy, COVID-19 Drug Treatment, Coronavirus Infections complications, Pneumonia, Viral complications, Tuberculosis, Pulmonary complications
Abstract

Competing Interests: Conflict of interest: M. Tadolini has nothing to disclose. Conflict of interest: L.R. Codecasa has nothing to disclose. Conflict of interest: J-M. García-García has nothing to disclose. Conflict of interest: F-X. Blanc has nothing to disclose. Conflict of interest: S. Borisov has nothing to disclose. Conflict of interest: J-W. Alffenaar has nothing to disclose. Conflict of interest: C. Andréjak has nothing to disclose. Conflict of interest: P. Bachez has nothing to disclose. Conflict of interest: P-A. Bart has nothing to disclose. Conflict of interest: E. Belilovski has nothing to disclose. Conflict of interest: J. Cardoso-Landivar has nothing to disclose. Conflict of interest: R. Centis has nothing to disclose. Conflict of interest: L. D'Ambrosio has nothing to disclose. Conflict of interest: M-L. De Souza-Galvão has nothing to disclose. Conflict of interest: A. Dominguez-Castellano has nothing to disclose. Conflict of interest: S. Dourmane has nothing to disclose. Conflict of interest: M. Fréchet Jachym has nothing to disclose. Conflict of interest: A. Froissart has nothing to disclose. Conflict of interest: V. Giacomet has nothing to disclose. Conflict of interest: D. Goletti has nothing to disclose. Conflict of interest: S. Grard has nothing to disclose. Conflict of interest: G. Gualano has nothing to disclose. Conflict of interest: A. Izadifar has nothing to disclose. Conflict of interest: D. Le Du has nothing to disclose. Conflict of interest: M. Marín Royo has nothing to disclose. Conflict of interest: J. Mazza-Stalder has nothing to disclose. Conflict of interest: I. Motta has nothing to disclose. Conflict of interest: C.W.M. Ong has nothing to disclose. Conflict of interest: F. Palmieri has nothing to disclose. Conflict of interest: F. Rivière has nothing to disclose. Conflict of interest: T. Rodrigo has nothing to disclose. Conflict of interest: D.R. Silva has nothing to disclose. Conflict of interest: A. Sánchez-Montalvá has nothing to disclose. Conflict of interest: M. Saporiti has nothing to disclose. Conflict of interest: P. Scarpellini has nothing to disclose. Conflict of interest: F. Schlemmer has nothing to disclose. Conflict of interest: A. Spanevello has nothing to disclose. Conflict of interest: E. Sumarokova has nothing to disclose. Conflict of interest: E. Tabernero has nothing to disclose. Conflict of interest: P.A. Tambyah has nothing to disclose. Conflict of interest: S. Tiberi has nothing to disclose. Conflict of interest: A. Torre has nothing to disclose. Conflict of interest: D. Visca has nothing to disclose. Conflict of interest: M. Zabaleta Murguiondo has nothing to disclose. Conflict of interest: G. Sotgiu has nothing to disclose. Conflict of interest: G.B. Migliori has nothing to disclose.

Published
2020
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10. Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report.

Author

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

Subjects
Adult, Aged, Female, Humans, Male, Middle Aged, Pharmacovigilance, Prospective Studies, Antitubercular Agents adverse effects, Drug-Related Side Effects and Adverse Reactions diagnosis, Drug-Related Side Effects and Adverse Reactions epidemiology, Tuberculosis, Multidrug-Resistant drug therapy
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 ( i.e. bedaquiline, delamanid) and repurposed ( i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1-2) and 57 (11.3%) as serious (grade 3-5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care., Competing Interests: Conflict of interest: S. Borisov has nothing to disclose. Conflict of interest: E. Danila has nothing to disclose. Conflict of interest: A. Maryandyshev has nothing to disclose. Conflict of interest: M. Dalcolmo has nothing to disclose. Conflict of interest: S. Miliauskas has nothing to disclose. Conflict of interest: L. Kuksa reports personal fees for trial participation from Otsuka and Tibotec, personal fees for lectures from Johnson and Johnson Services Inc., outside the submitted work. Conflict of interest: S. Manga has nothing to disclose. Conflict of interest: A. Skrahina has nothing to disclose. Conflict of interest: S. Diktanas reports personal fees for trial participation from Otsuka, grants for meeting attendance from Janssen (Sirturo), outside the submitted work. Conflict of interest: L.R. Codecasa has nothing to disclose. Conflict of interest: A. Aleksa has nothing to disclose. Conflict of interest: J. Bruchfeld has nothing to disclose. Conflict of interest: A. Koleva has nothing to disclose. Conflict of interest: A. Piubello has nothing to disclose. Conflict of interest: Z.F. Udwadia has nothing to disclose. Conflict of interest: O.W. Akkerman has nothing to disclose. Conflict of interest: E. Belilovski has nothing to disclose. Conflict of interest: E. Bernal has nothing to disclose. Conflict of interest: M.J. Boeree has nothing to disclose. Conflict of interest: J. Cadiñanos Loidi has nothing to disclose. Conflict of interest: Q. Cai has nothing to disclose. Conflict of interest: J.J. Cebrian Gallardo has nothing to disclose. Conflict of interest: M. Dara has nothing to disclose. Conflict of interest: E. Davidavičienė has nothing to disclose. Conflict of interest: L. Davies Forsman has nothing to disclose. Conflict of interest: J. De Los Rios has nothing to disclose. Conflict of interest: J. Denholm has nothing to disclose. Conflict of interest: J. Drakšienė has nothing to disclose. Conflict of interest: R. Duarte has nothing to disclose. Conflict of interest: S.E. Elamin has nothing to disclose. Conflict of interest: N. Escobar Salinas has nothing to disclose. Conflict of interest: M. Ferrarese has nothing to disclose. Conflict of interest: A. Filippov has nothing to disclose. Conflict of interest: A. Garcia has nothing to disclose. Conflict of interest: J.M. García-García has nothing to disclose. Conflict of interest: I. Gaudiesiute has nothing to disclose. Conflict of interest: B. Gavazova has nothing to disclose. Conflict of interest: R. Gayoso has nothing to disclose. Conflict of interest: R. Gomez Rosso has nothing to disclose. Conflict of interest: V. Gruslys has nothing to disclose. Conflict of interest: G. Gualano has nothing to disclose. Conflict of interest: W. Hoefsloot has nothing to disclose. Conflict of interest: J. Jonsson has nothing to disclose. Conflict of interest: E. Khimova has nothing to disclose. Conflict of interest: H. Kunst has nothing to disclose. Conflict of interest: R. Laniado-Laborín has nothing to disclose. Conflict of interest: Y. Li has nothing to disclose. Conflict of interest: C. Magis-Escurra has nothing to disclose. Conflict of interest: V. Manfrin has nothing to disclose. Conflict of interest: V. Marchese has nothing to disclose. Conflict of interest: E. Martínez Robles has nothing to disclose. Conflict of interest: A. Matteelli has nothing to disclose. Conflict of interest: J. Mazza-Stalder has nothing to disclose. Conflict of interest: C. Moschos has nothing to disclose. Conflict of interest: M. Muñoz-Torrico has nothing to disclose. Conflict of interest: H. Mustafa Hamdan has nothing to disclose. Conflict of interest: B. Nakčerienė has nothing to disclose. Conflict of interest: L. Nicod has nothing to disclose. Conflict of interest: M. Nieto Marcos has nothing to disclose. Conflict of interest: D.J. Palmero has nothing to disclose. Conflict of interest: F. Palmieri has nothing to disclose. Conflict of interest: A. Papavasileiou has nothing to disclose. Conflict of interest: M-C. Payen has nothing to disclose. Conflict of interest: A. Pontarelli has nothing to disclose. Conflict of interest: S. Quirós has nothing to disclose. Conflict of interest: A. Rendon has nothing to disclose. Conflict of interest: L. Saderi has nothing to disclose. Conflict of interest: A. Šmite has nothing to disclose. Conflict of interest: I. Solovic has nothing to disclose. Conflict of interest: M.B. Souleymane has nothing to disclose. Conflict of interest: M. Tadolini has nothing to disclose. Conflict of interest: M. van den Boom has nothing to disclose. Conflict of interest: M. Vescovo has nothing to disclose. Conflict of interest: P. Viggiani has nothing to disclose. Conflict of interest: A. Yedilbayev has nothing to disclose. Conflict of interest: R. Zablockis has nothing to disclose. Conflict of interest: D. Zhurkin has nothing to disclose. Conflict of interest: M. Zignol has nothing to disclose. Conflict of interest: D. Visca has nothing to disclose. Conflict of interest: A. Spanevello has nothing to disclose. Conflict of interest: J.A. Caminero has nothing to disclose. Conflict of interest: J-W. Alffenaar has nothing to disclose. Conflict of interest: S. Tiberi has nothing to disclose. Conflict of interest: R. Centis has nothing to disclose. Conflict of interest: L. D'Ambrosio has nothing to disclose. Conflict of interest: E. Pontali has nothing to disclose. Conflict of interest: G. Sotgiu has nothing to disclose. Conflict of interest: G.B. Migliori has nothing to disclose., (Copyright ©ERS 2019.)

Published
2019
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11. 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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12. 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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