International Journal of Infectious Diseases (2019-06-01)

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

  • Onno Akkerman,
  • Alena Aleksa,
  • Jan-Willem Alffenaar,
  • Nada Hassan Al-Marzouqi,
  • Miguel Arias-Guillén,
  • Evgeny Belilovski,
  • Enrique Bernal,
  • Martin J. Boeree,
  • Sergey E. Borisov,
  • Judith Bruchfeld,
  • Julen Cadiñanos Loidi,
  • Qingshan Cai,
  • Jose A. Caminero,
  • Jose Joaquín Cebrian Gallardo,
  • Rosella Centis,
  • Luigi Ruffo Codecasa,
  • Lia D’Ambrosio,
  • Margareth Dalcolmo,
  • Edvardas Danila,
  • Masoud Dara,
  • Edita Davidavičienė,
  • Lina Davies Forsman,
  • Jorge De Los Rios Jefe,
  • Justin Denholm,
  • Raquel Duarte,
  • Seifeldin Eltaeb Elamin,
  • Maurizio Ferrarese,
  • Alexey Filippov,
  • Shashank Ganatra,
  • Ana Garcia,
  • José-María García-García,
  • Regina Gayoso,
  • Angela Maria Giraldo Montoya,
  • Roscio Gomez Gomez Rosso,
  • Gina Gualano,
  • Wouter Hoefsloot,
  • Biljana Ilievska-Poposka,
  • Jerker Jonsson,
  • Elena Khimova,
  • Liga Kuksa,
  • Heinke Kunst,
  • Rafael Laniado-Laborín,
  • Yang Li,
  • Cecile Magis-Escurra,
  • Vinicio Manfrin,
  • Selene Manga,
  • Valentina Marchese,
  • Elena Martínez Robles,
  • Andrei Maryandyshev,
  • Alberto Matteelli,
  • Giovanni Battista Migliori,
  • Jai B. Mullerpattan,
  • Marcela Munoz-Torrico,
  • Hamdan Mustafa Hamdan,
  • Magnolia Nieto Marcos,
  • Noorliza Mohamad Noordin,
  • Domingo Juan Palmero,
  • Fabrizio Palmieri,
  • Marie-Christine Payen,
  • Alberto Piubello,
  • Emanuele Pontali,
  • Agostina Pontarelli,
  • Sarai Quirós,
  • Adrian Rendon,
  • Alena Skrahina,
  • Agnese Šmite,
  • Ivan Solovic,
  • Giovanni Sotgiu,
  • Mahamadou Bassirou Souleymane,
  • Antonio Spanevello,
  • Maja Stošić,
  • Marina Tadolini,
  • Simon Tiberi,
  • Zarir Farokh Udwadia,
  • Martin van den Boom,
  • Marisa Vescovo,
  • Pietro Viggiani,
  • Dina Visca,
  • Dmitry Zhurkin,
  • Matteo Zignol

Journal volume & issue
Vol. 83
pp. 72 – 76

Abstract

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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. Keywords: Tuberculosis, MDR-TB, Adverse events, Monitoring, Delamanid, Bedaquiline