Limited Benefit of the New Shorter Multidrug-Resistant Tuberculosis Regimen in Europe

Lange, Christoph; Duarte, Raquel; Fréchet-Jachym, Mathilde; Guenther, Gunar; Guglielmetti, Lorenzo; Olaru, Ioana D.; Oliveira, Olena; Rumetshofer, Rudolf; Véziris, Nicolas; Leth, Frank van

doi:10.1164/rccm.201606-1097le

Cited by 69 publications

(52 citation statements)

References 7 publications

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“…These results are largely in line with published data for other regions; the proportion of 6.2% eligible patients was slightly higher than in pooled findings from the European and Latin American settings (4.0%)10 and slightly lower than in a Western European cohort (7.8%) 7. Of note, even in the context of settings with a well-developed quality controlled DST, many DST profiles were not complete.…”

supporting

confidence: 88%

Multidrug-resistant TB in Eastern region of the EU: is the shorter regimen an exception or a rule?

Balabanova

Fiebig

Ignatyeva³

et al. 2017

Thorax

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WHO recently recommended the use of a shorter multidrug-resistant TB (MDR-TB) regimen under programmatic conditions. We assessed eligibility for this regimen in a cohort of 737 adult patients with MDR-TB from Latvia, Lithuania, Estonia and Bucharest city recruited in 2007 and 2009. Only 4.2% of the patients were eligible for this regimen. Ethambutol (64%), pyrazinamide resistance (58%) and previous exposure to second-line TB drugs were major reasons for non-eligibility. High-level resistance to isoniazid is expected due to widespread prevalence of mutations. In Eastern Europe, the use of the shorter regimen might be an exception rather than a rule.

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supporting

confidence: 88%

Multidrug-resistant TB in Eastern region of the EU: is the shorter regimen an exception or a rule?

Balabanova

Fiebig

Ignatyeva³

et al. 2017

Thorax

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“…There are clearly some settings where RR/MDR‐TB is strongly associated with second‐line drug resistance, and therefore with low proportions of patients who would benefit from the shorter regimen . In these settings, expanded access to the new TB drugs, following WHO guidance, is urgently needed .…”

Section: Should the Shorter Mdr‐tb Regimen Be Implemented Globally: Pmentioning

confidence: 99%

“…This recommendation has renewed hopes of patients and doctors alike, promising a treatment success rate of 83.7% compared with the global MDR‐TB treatment success rate of 50% using the conventional ~20‐month regimen . Meanwhile, substantial concerns have been raised about the shorter regimen and the proportion of eligible patients …”

Section: Should the Shorter Mdr‐tb Regimen Be Implemented Globally: Pmentioning

confidence: 99%

“…Furthermore, it is not unusual in some countries, for example in South Africa, that at least half of MDR‐TB patients have been treated previously for drug‐sensitive TB, making resistance to pyrazinamide and ethambutol much more likely. Therefore, the high prevalence of resistance to agents contained within the WHO‐advocated shorter regimen, combined with the other exclusions described in the updated guidelines, makes this regimen likely to be poorly applicable in many high burden MDR‐TB countries . Furthermore, the new guidelines are vague on the threshold of resistance to the various drugs that would be acceptable for implementation.…”

Section: Should the Shorter Mdr‐tb Regimen Be Implemented Globally: Pmentioning

confidence: 99%

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Recent controversies about MDR and XDR‐TB: Global implementation of the WHO shorter MDR‐TB regimen and bedaquiline for all with MDR‐TB?

et al. 2017

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Tuberculosis (TB) is now the biggest infectious disease killer worldwide. Although the estimated incidence of TB has marginally declined over several years, it is out of control in some regions including in Africa. The advent of multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB) threatens to further destabilize control in several regions of the world. Drug-resistant TB constitutes a significant threat because it underpins almost 25% of global TB mortality, is associated with high morbidity, is a threat to healthcare workers and is unsustainably costly to treat. The advent of highly resistant TB with emerging bacillary resistance to newer drugs has raised further concern. Encouragingly, in addition to preventative strategies, several interventions have recently been introduced to curb the drug-resistant TB epidemic, including newer molecular diagnostic tools, new (bedaquiline and delamanid) and repurposed (linezolid and clofazimine) drugs and shorter and individualized treatment regimens. However, there are several controversies that surround the use of new drugs and regimens, including whether, how and to what extent they should be used, and who specifically should be treated so that outcomes are optimally improved without amplifying the burden of drug resistance, and other potential drawbacks, thus sustaining effectiveness of the new drugs. The equipoise surrounding these controversies is discussed and some recommendations are provided.

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“…Publications from Europe have reported eligibility rates ranging from 6.2% to 14% [7][8][9][10]. Data from Pakistan and Brazil showed more optimistic eligibility rates of 50% or higher [11,12].…”

mentioning

confidence: 99%

The shorter multidrug-resistant tuberculosis treatment regimen in Singapore: are patients from South-East Asia eligible?

et al. 2017

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Multidrug-resistant tuberculosis (MDR-TB) is a major public health challenge, with an estimated 480 000 new cases emerging globally each year [1]. Treatment success rates using the 20-month conventional World Health Organization (WHO) regimen have been low, being about 52% in 2013 [1]. Observational studies in Bangladesh and several African countries have shown success rates of 84% using a shorter regimen [2][3][4]. Based on these studies, in May 2016 the WHO conditionally recommended a standardised, shorter 9-12-month regimen for MDR pulmonary tuberculosis (PTB), comprising a 4-6-month intensive phase with a combination of kanamycin, moxifloxacin, prothionamide, clofazimine, pyrazinamide, high-dose isoniazid and ethambutol, followed by a 5-month continuation phase containing moxifloxacin, clofazimine, ethambutol and pyrazinamide [5]. Confirmed resistance (except to isoniazid) or suspected ineffectiveness to a drug in this regimen is one of the exclusion criteria [5].

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Limited Benefit of the New Shorter Multidrug-Resistant Tuberculosis Regimen in Europe

Cited by 69 publications

References 7 publications

Multidrug-resistant TB in Eastern region of the EU: is the shorter regimen an exception or a rule?

Multidrug-resistant TB in Eastern region of the EU: is the shorter regimen an exception or a rule?

Recent controversies about MDR and XDR‐TB: Global implementation of the WHO shorter MDR‐TB regimen and bedaquiline for all with MDR‐TB?

The shorter multidrug-resistant tuberculosis treatment regimen in Singapore: are patients from South-East Asia eligible?

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