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

Akkerman, Onno W.; Aleksa, Alena; Alffenaar, Jan-Willem; Al-Marzouqi, Nada Hassan; Arias-Guillén, Miguel; Belilovski, Evgeny; Bernal, Enrique; Boeree, Martin J.; Borisov, Sergey; Bruchfeld, Judith; Cadiñanos, Julen; Cai, Qingshan; Caminero, José A.; Gallardo, José Joaquín Cebrián; Centis, Rosella; Codecasa, Luigi; D’Ambrosio, Lia; Dalcolmo, Margareth Pretti; Danila, Edvardas; Dara, Masoud; Davidavičienė, Edita; Forsman, Lina Davies; Jefe, Jorge De Los Rios; Denholm, Justin T.; Duarte, Raquel; Elamin, Seifeldin Eltaeb; Ferrarese, Maurizio; Филиппов, А. В.; Ganatra, Shashank; Garcı́a, Ana Maria; García-García, José-María; Gayoso, Regina; Montoya, Ángela María Giraldo; Rosso, Roscio Gomez Gomez; Gualano, Gina; Hoefsloot, Wouter; Ilievska-Poposka, Biljana; Jonsson, Jerker; Khimova, Elena; Kukša, Līga; Kunst, Heinke; Laniado-Laborı́n, Rafael; Li, Yang; Magis-Escurra, Cécile; Manfrin, Vinicio; Manga, Selene; Marchese, Valentina; Robles, E. Martínez; Maryandyshev, Andrei; Matteelli, Alberto; Migliori, Giovanni Battista; Mullerpattan, Jai; Muñoz-Torrico, Marcela; Hamdan, Hamdan Mustafa; Marcos, Magnolia Nieto; Noordin, Noorliza Mohamad; Palmero, Domingo; Palmieri, Fabrizio; Payen, Marie-Christine; Piubello, Alberto; Pontali, Emanuele; Pontarelli, Agostina; Quirós, Sarái; Rendón, Adrián; Skrahina, Alena; Šmite, Agnese; Solovič, Ivan; Sotgiu, Giovanni; Souleymane, Mahamadou Bassirou; Spanevello, Antonio; Stošić, Maja; Tadolini, Marina; Tiberi, Simon; Udwadia, Zarir; Boom, Martin van den; Vescovo, Marisa; Viggiani, Pietro; Visca, Dina; Zhurkin, Dmitry; Zignol, Matteo; monitoring, adverse events

doi:10.1016/j.ijid.2019.03.036

Cited by 45 publications

(37 citation statements)

References 9 publications

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“…A comprehensive review on TB and rehabilitation [44] recommended that future studies investigating pulmonary rehabilitation include the following information to ensure comparative analyses: a) Patients' characteristics (age, sex, ethnicity, etc); b) A description of the TB disease, (history of previous treatment, bacteriological status, drug-resistance profile, treatment history -drugs and regimens; and adverse events observed) [7,8]; c)…”

Section: Priorities For Researchmentioning

confidence: 99%

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Post-Tuberculosis (TB) Treatment: The Role of Surgery and Rehabilitation

et al. 2020

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Even though the majority of tuberculosis (TB) programmes consider their work completed when a patient is ‘successfully’ cured, patients often continue to suffer with post-treatment or surgical sequelae. This review focuses on describing the available evidence with regard to the diagnosis and management of post-treatment and surgical sequelae (pulmonary rehabilitation). We carried out a non-systematic literature review based on a PubMed search using specific key-words, including various combinations of ‘TB’, ‘MDR-TB’, ‘XDR-TB’, ‘surgery’, ‘functional evaluation’, ‘sequelae’ and ‘pulmonary rehabilitation’. References of the most important papers were retrieved to improve the search accuracy. We identified the main areas of interest to describe the topic as follows: 1) ‘Surgery’, described through observational studies and reviews, systematic reviews and meta-analyses, IPD (individual data meta-analyses), and official guidelines (GRADE (Grading of Recommendations Assessment, Development and Evaluation) or not GRADE-based); 2) Post-TB treatment functional evaluation; and 3) Pulmonary rehabilitation interventions. We also highlighted the priority areas for research for the three main areas of interest. The collection of high-quality standardized variables would allow advances in the understanding of the need for, and effectiveness of, pulmonary rehabilitation at both the individual and the programmatic level. The initial evidence supports the importance of the adequate functional evaluation of these patients, which is necessary to identify those who will benefit from pulmonary rehabilitation.

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Section: Priorities For Researchmentioning

confidence: 99%

“…The availability of new drugs (bedaquiline, delamanid, and pretomanid) after many years of neglect provides new perspectives, improved success rates and a reduced prevalence of adverse events [6][7][8]. The rapid detection of TB is also key in order to catch the disease process early and preserve lung function.…”

Section: Introductionmentioning

confidence: 99%

Post-Tuberculosis (TB) Treatment: The Role of Surgery and Rehabilitation

et al. 2020

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“…By the end of January 2019, 16 countries had reported a total of 891 AEs to this database (C. Halleux, personal communication). Third, 27 countries that reportedly faced difficulties in submitting data to the global aDSM database have committed to report to the recently implemented Global TB Network hosted by the World Association for Infectious Diseases and Immunological Disorders (www.waidid.org/) [63,64]. So far, 18 countries have shared data, which were planned for publication in the second quarter of 2019 [64].…”

Section: Why Active Drug Safety Monitoring?mentioning

confidence: 99%

Integration of drug safety monitoring in tuberculosis treatment programmes: country experiences

et al. 2019

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New drugs and shorter treatments for drug-resistant tuberculosis (DR-TB) have become available in recent years and active pharmacovigilance (PV) is recommended by the World Health Organization (WHO) at least during the early phases of implementation, with active drug safety monitoring and management (aDSM) proposed for this. We conducted a literature review of papers reporting on aDSM. Up to 18 April, 2019, results have only been published from one national aDSM programme. Because aDSM is being introduced in many low- and middle-income countries, we also report experiences in introducing it into DR-TB treatment programmes, targeting the reporting of a restricted set of adverse events (AEs) as per WHO-recommended aDSM principles for the period 2014–2017. Early beneficial effects of active PV for TB patients include increased awareness about the occurrence, detection and management of AEs during TB treatment, and the increase of spontaneous reporting in some countries. However, because PV capacity is low in most countries and collaboration between national TB programmes and national PV centres remains weak, parallel and coordinated co-development of the capacities of both TB programmes and PV centres is needed.

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“…Conventional anti-TB drugs primarily target processes required for cell growth and replication, and are less efficacious against non-replicating bacteria, resulting in lengthy treatments in both drug-susceptible (DS-TB) and drug-resistant TB (DR-TB) cases [1,3]. In addition, current treatments for DR-TB are associated with low cure rates and toxicity [4][5][6]. Therefore, the successful elimination of the disease requires the development of new anti-TB drugs ideally active against non-replicating bacterial subpopulations and drug-resistant strains.…”

Section: Introductionmentioning

confidence: 99%

Oxidative Phosphorylation—an Update on a New, Essential Target Space for Drug Discovery in Mycobacterium tuberculosis

2020

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New drugs with new mechanisms of action are urgently required to tackle the global tuberculosis epidemic. Following the FDA-approval of the ATP synthase inhibitor bedaquiline (Sirturo®), energy metabolism has become the subject of intense focus as a novel pathway to exploit for tuberculosis drug development. This enthusiasm stems from the fact that oxidative phosphorylation (OxPhos) and the maintenance of the transmembrane electrochemical gradient are essential for the viability of replicating and non-replicating Mycobacterium tuberculosis (M. tb), the etiological agent of human tuberculosis (TB). Therefore, new drugs targeting this pathway have the potential to shorten TB treatment, which is one of the major goals of TB drug discovery. This review summarises the latest and key findings regarding the OxPhos pathway in M. tb and provides an overview of the inhibitors targeting various components. We also discuss the potential of new regimens containing these inhibitors, the flexibility of this pathway and, consequently, the complexity in targeting it. Lastly, we discuss opportunities and future directions of this drug target space.

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

Cited by 45 publications

References 9 publications

Post-Tuberculosis (TB) Treatment: The Role of Surgery and Rehabilitation

Post-Tuberculosis (TB) Treatment: The Role of Surgery and Rehabilitation

Integration of drug safety monitoring in tuberculosis treatment programmes: country experiences

Oxidative Phosphorylation—an Update on a New, Essential Target Space for Drug Discovery in Mycobacterium tuberculosis

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