Delamanid for rifampicin-resistant tuberculosis: a retrospective study from South Africa

Mohr-Holland, Erika; Hughes, Jennifer; Reuter, Anja; Durán, Laura Triviño; Ferlazzo, Gabriella; Daniels, Johnny; Azevedo, Virginia De; Kock, Yulene; Steele, Sarah Jane; Shroufi, Amir; Adè, S.; Alikhanova, Natavan; Benedetti, Guido; Edwards, Jeffrey K.; Cox, Helen; Furin, Jennifer; Isaakidis, Petros

doi:10.1183/13993003.00017-2018

Cited by 41 publications

(24 citation statements)

References 27 publications

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“…However, only 2/87 (2.3%) interrupted bedaquiline and/or delamanid for cardiac adverse events. The other adverse events reported in the various studies were rarely attributed to bedaquiline, delamanid or both [8,[13][14][15]. Nevertheless, in most cases there were several confounding factors, such as co-administered anti-TB drugs and comorbidities, which make univocal attribution questionable [15].…”

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confidence: 99%

“…Seven studies [8,[10][11][12][13][14][15] met the inclusion criteria (one patient [10] was also described in the manuscript by MARYANDYSHEV et al [12] with additional information and, therefore, was counted only once in this review): two letters [11,13] and four articles [8,12,14,15] published between 2016 and 2018 have been included.…”

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confidence: 99%

“…Bedaquiline and delamanid were prescribed concomitantly and sequentially in 41/55 (74.5%) and 14/55 cases, respectively [11][12][13][14][15]; one study did not specify (table 1) [8].…”

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Combined treatment of drug-resistant tuberculosis with bedaquiline and delamanid: a systematic review

et al. 2018

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The World Health Organization (WHO) estimated that 490 000 cases of multidrug-resistant (MDR) tuberculosis (TB) (defined as TB caused by Mycobacterium tuberculosis strains resistant to at least isoniazid and rifampicin) occurred in 2016. Among them, ∼6.2% had extensively drug-resistant (XDR) TB (i.e. TB caused by MDR strains with additional resistance to fluoroquinolones and at least one second-line injectable drug) [1]. An appropriate pharmacological regimen can bacteriologically and clinically cure, and prevent the emergence and spread of further resistances. However, the management of MDR-and other chronic TB cases can be clinically challenging, as well as raise public health concerns, in patients with limited treatment options. An insufficient number of active drugs during both intensive and continuation phases cannot allow the patient to be saved, while creating further resistance [2]. Due to this reason, to date, the overall success rate for MDR-TB is less than 60%, and is lower than 40% for XDR-TB [1]. Furthermore, the incidence of adverse events can be particularly high when administering anti-MDR-TB drugs [2-6]. The recent availability of bedaquiline and delamanid could positively affect poor treatment outcomes of MDR-TB cases, reduce the occurrence of adverse events, and halt further drug resistance and transmission. Bedaquiline is effective and safe, even if increased QT interval and cardiac complications have been recorded [3-7]. Delamanid-containing regimens can achieve treatment success in up to 80% of MDR/XDR-TB cases, with limited adverse events, such as prolonged QT interval and emesis [4, 8]. The WHO does not recommend combination of bedaquiline and delamanid. owing to a potential high risk of cardiac toxicity [9]; however, in difficult-to-treat MDR/XDR-TB cases, where pharmacological alternatives to design a regimen with four active drugs are not available, bedaquiline and delamanid combined treatment, in addition to optimised background regimen, was proposed as a life-saving option [10, 11]. The aim of the present study was to perform a systematic review on the efficacy and safety of co-administered bedaquiline and delamanid in MDR-TB patients. Peer-reviewed articles written in English reporting on efficacy/effectiveness, safety, and tolerability of individualised regimens containing both bedaquiline and delamanid in patients with culture-and drug susceptibility testing (DST)-confirmed MDR/XDR-TB were selected. PubMed and Embase were used to identify any relevant manuscripts published up until May 8, 2018, excluding editorials, reviews, experimental studies on animal models, manuscripts describing TB patients recruited without a confirmed bacteriological diagnosis, and conference abstracts (because of limited available information). @ERSpublications Efficacy and safety of co-administered bedaquiline and delamanid in MDR-TB patients http://ow.ly/ Ctvj30kreEP

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Combined treatment of drug-resistant tuberculosis with bedaquiline and delamanid: a systematic review

et al. 2018

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“…The availability of new anti-tuberculosis (e.g., bedaquiline, delamanid, pretomanid) and repurposed (e.g., linezolid, carbapenems) drugs has improved the treatment success rate and reduced the risk of Mycobacterium tuberculosis transmission associated with difficult-to-treat cases. However, pharmacological options are not available or sufficient in some low-income, high TB incidence settings (Collaborative Group et al, 2018; Collaborative Group for the Meta-Analysis of Individual Patient Data in MDR-TB treatment--2017Mohr et al, 2018;Mbuagbaw et al, 2019;Pontali et al, 2017Pontali et al, , 2018.…”

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confidence: 99%

New perspectives on difficult-to-treat tuberculosis based on old therapeutic approaches

Mondoni

Centanni

Sotgiu

2020

International Journal of Infectious Diseases

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Tuberculosis (TB) is an important clinical and public health issue worldwide. Despite improved treatment success rates following the introduction of antibiotics in daily clinical practice, the expected decline in incidence has been hampered by HIV epidemics and multi-and extensively drug-resistant TB. During the pre-antibiotic era, TB therapies were mainly based on improving hygiene conditions, strengthening the immune system, and targeting the rest of the affected lungs with invasive techniques. Detailed knowledge of old non-pharmacological therapies might support physicians and researchers in the identification of new solutions for difficult-to-treat patients. We performed a narrative literature review on the main old therapeutic options prescribed for patients with TB. The main recommendations and contraindications of sanatorium therapies (i.e., bed rest, fresh air, sunlight) and pulmonary collapse techniques are reviewed, evaluating their physiological basis and their impact on patient outcomes. We report studies describing new interventional pulmonary and surgical techniques and assess new perspectives based on old medical and surgical treatments, whose potential implementation could help complicated patients.

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“…To date, retrospective studies reporting the effectiveness of delamanid have been descriptive in nature (Table ), which precluded researchers from looking at some crucial issues, especially the time to sputum culture conversion and the treatment outcome. Cohorts from South Africa (Mohr et al, ), Hongkong (Chang et al, ), Latvia (Kuksa, Barkane, Hittel, & Gupta, ), and South Korea (Kim et al, ) focused on complicated MDR‐TB and reported a conversion rate at week 24 of greater than 70%. The first multicenter study conducted in resource‐limited settings also reported an encouraging 24‐week conversion rate of 80%, although 91% of patients were concurrently treated with linezolid (Hafkin, Hittel, Martin, & Gupta, ).…”

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confidence: 99%

Bedaquiline and delamanid in the treatment of multidrug‐resistant tuberculosis: Promising but challenging

Sun

Zhang

2018

Drug Development Research

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Improving treatment outcomes in multidrug‐resistant tuberculosis (MDR‐TB) is partly hampered by inadequate effective antitubercular agents. Development of bedaquiline and delamanid has potentially changed the treatment landscape for MDR‐TB. This review provides an update on the progress of these novel antitubercular agents. We review published studies aimed at evaluating clinical efficacy and effectiveness of bedaquiline and delamanid. Five prospective clinical studies and seven retrospective studies on bedaquiline showed that patients treated with a bedaquiline‐containing regimen had a high culture conversion rate ranging from 65 to 100% and a satisfactory treatment outcome. The combined use with linezolid might add to the effectiveness of bedaquiline. Controversies about bedaquiline resistance are discussed. Three clinical trials have reported outcomes on delamanid and showed that introducing delamanid to a background regimen improved culture conversion rate at 2 months from 29.6% to more than 40%. A higher favorable treatment rate was also observed among patients who received delamanid for more than 6 months, but about a quarter of patients defaulted in the control group. Seven retrospective studies were summarized and found a treatment benefit as well. More reliable evidence from randomized clinical trials reporting on the treatment outcomes is needed urgently to support a strong recommendation for the use of delamanid. Advances in the combined use of bedaquiline and delamanid are also reviewed, and the combination may be well tolerated but requires electrocardiograph monitoring.

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Delamanid for rifampicin-resistant tuberculosis: a retrospective study from South Africa

Cited by 41 publications

References 27 publications

Combined treatment of drug-resistant tuberculosis with bedaquiline and delamanid: a systematic review

Combined treatment of drug-resistant tuberculosis with bedaquiline and delamanid: a systematic review

New perspectives on difficult-to-treat tuberculosis based on old therapeutic approaches

Bedaquiline and delamanid in the treatment of multidrug‐resistant tuberculosis: Promising but challenging

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