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

Koirala, S; Borisov, Sergey; Danila, Edvardas; Марьяндышев, А О; Shrestha, B; Lukhele, Nomthandazo; Dalcolmo, Margareth Pretti; Shakya, Sabina; Miliauskas, Skaidrius; Kukša, Līga; Manga, Selene; Aleksa, Alena; Denholm, Justin; Khadka, Hari Bahadur; Skrahina, Alena; Diktanas, Saulius; Ferrarese, Maurizio; Bruchfeld, Judith; Koleva, Antoniya; Piubello, Alberto; Koirala, G S; Udwadia, Zarir F; Palmero, Domingo; Muñoz-Torrico, Marcela; Gc, Ravi; Gualano, Gina; Grecu, Victor; Motta, Ilaria; Papavasileiou, Apostolos; Li, Y; Hoefsloot, Wouter; Kunst, Heinke; Mazza-Stalder, Jesica; Payen, M C; Akkerman, Onno W.; Bernal, Enrique; Manfrin, Vinicio; Matteelli, Alberto; Hamdan, H. Mustafa; Marcos, Magnolia Nieto; Cadiñanos, Julen; Gallardo, José Joaquín Cebrián; Duarte, Raquel; Salinas, Nadia Escobar; Rosso, Roscio Gomez Gomez; Laniado-Laborı́n, Rafael; Robles, E. Martínez; Fernandez, Shane; Rendón, Adrián; Solovič, Ivan; Tadolini, Marina; Viggiani, Pietro; Belilovski, Evgeny; Boeree, Martin J.; Cai, Qingshan; Davidavičienė, Edita; Forsman, Lina Davies; Ríos, Jorge De Los; Drakšienė, Jacinta; Duga, Alemayehu Lelisa; Elamin, Seifeldin Eltaeb; Филиппов, А. В.; Garcı́a, Ana Maria; Gaudiešiūtė, Ieva; Gavazova, Blagovesta; Gayoso, Regina; Gruslys, Vygantas; Jonsson, Jerker; Khimova, Elena; Madonsela, G; Magis-Escurra, Cécile; Marchese, Valentina; Matei, M; Moschos, Charalampos; Nakčerienė, Birutė; Nicod, Laurent; Palmieri, Fabrizio; Pontarelli, Agostina; Šmite, Agnese; Souleymane, Mahamadou Bassirou; Vescovo, Marisa; Zablockis, Rolandas; Zhurkin, Dmitry; Alffenaar, J-W C; Caminero, José A.; Codecasa, Luigi; García-García, José-María; Esposito, Susanna; Saderi, Laura; Spanevello, Antonio; Visca, Dina; Tiberi, Simon; Pontali, Emanuele; Centis, Rosella; D’Ambrosio, Lia; Boom, Martin van den; Sotgiu, Giovanni; Migliori, Giovanni Battista

doi:10.1016/j.pulmoe.2021.02.006

Cited by 38 publications

(34 citation statements)

References 44 publications

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“…Limited data concerning the interactions between bedaquiline and antiretroviral medicines are available, and most of these are based on studies conducted in healthy volunteers [ 51 , 52 , 53 ]. In an observational study performed in HIV-infected and HIV-seronegative adult patients (age ≥18 years) with MDR-TB, Brill et al showed that nevirapine did not show a relevant effect on bedaquiline and M2 exposure in HIV/MDR-TB co-infected patients.…”

Section: Bedaquilinementioning

confidence: 99%

Treatment of Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis in Children: The Role of Bedaquiline and Delamanid

et al. 2021

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Multidrug-resistant (MDR) tuberculosis (TB) has been emerging at an alarming rate over the last few years. It has been estimated that about 3% of all pediatric TB is MDR, meaning about 30,000 cases each year. Although most children with MDR-TB can be successfully treated, up to five years ago effective treatment was associated with a high incidence of severe adverse effects and patients with extensively drug-resistant (XDR) TB had limited treatment options and no standard regimen. The main objective of this manuscript is to discuss our present knowledge of the management of MDR- and XDR-TB in children, focusing on the characteristics and available evidence on the use of two promising new drugs: bedaquiline and delamanid. PubMed was used to search for all of the studies published up to November 2020 using key words such as “bedaquiline” and “delamanid” and “children” and “multidrug-resistant tuberculosis” and “extensively drug-resistant tuberculosis”. The search was limited to articles published in English and providing evidence-based data. Although data on pediatric population are limited and more studies are needed to confirm the efficacy and safety of bedaquiline and delamanid, their use in children with MDR-TB/XDR-TB appears to have good tolerability and efficacy. However, more evidence on these new anti-TB drugs is needed to better guide their use in children in order to design effective shorter regimens and reduce adverse effects, drug interactions, and therapeutic failure.

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Section: Bedaquilinementioning

confidence: 99%

Treatment of Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis in Children: The Role of Bedaquiline and Delamanid

et al. 2021

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“…Among the patients treated with BDQ, but not DLM, 284 (74.2%) achieved treatment success. However, 63 (16.5%) patients were lost to follow-up, 11 (2.9%) failed, and 25 (6.5%) died (Koirala et al, 2021).…”

Section: Clinical Trialsmentioning

confidence: 99%

Mechanism of Action, Resistance, Synergism, and Clinical Implications of Delamanid Against Multidrug-Resistant Mycobacterium tuberculosis

et al. 2021

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Multidrug-resistant (MDR) isolates of Mycobacterium tuberculosis (MTB) remain a primary global threat to the end of tuberculosis (TB) era. Delamanid (DLM) is a nitro-dihydro-imidazooxazole derivative utilized to treat MDR-TB. DLM has distinct mechanism of action, inhibiting methoxy- and keto-mycolic acid (MA) synthesis through the F420 coenzyme mycobacteria system and generating nitrous oxide. While DLM resistance among MTB strains is uncommon, there are increasing reports in Asia and Europe, and such resistance will prolong the treatment courses of patients infected with MDR-TB. In this review, we address the antimycobacterial properties of DLM, report the global prevalence of DLM resistance, discuss the synergism of DLM with other anti-TB drugs, and evaluate the documented clinical trials to provide new insights into the clinical use of this antibiotic.

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“…In a subsequent Phase 3 study a delamanid-containing regimen did not meet the pre-specified non-inferiority criteria with regard to the median time to SCC over 6 months compared to OBR alone; however, a significant shorter time to SCC was demonstrated in sensitivity analyses and in subgroup analyses in patients without cavitation and/or fluoroquinolone resistance [43] . While global experience with delamanid remains limited, some data support its effectiveness in a multidrug background regimen [21] , [44] , [45] , [46] . Ongoing clinical trials evaluate delamanid in various oral regimens of 6–12 months duration in rifampicin-resistant (RR), MDR and FQ-resistant TB, some also in combination with bedaquiline (endTB – Table 1 ) and will provide a better understanding of its role in current MDR TB management.…”

Section: Introductionmentioning

confidence: 99%

The pipeline of new molecules and regimens against drug-resistant tuberculosis

Black

Buchwald

2021

Journal of Clinical Tuberculosis and Other Mycobacterial Diseas

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

Cited by 38 publications

References 44 publications

Treatment of Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis in Children: The Role of Bedaquiline and Delamanid

Treatment of Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis in Children: The Role of Bedaquiline and Delamanid

Mechanism of Action, Resistance, Synergism, and Clinical Implications of Delamanid Against Multidrug-Resistant Mycobacterium tuberculosis

The pipeline of new molecules and regimens against drug-resistant tuberculosis

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