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New Antituberculosis Drugs: From Clinical Trial to Programmatic Use
Treatment of multidrug-resistant tuberculosis (MDR-TB) cases is challenging because it relies on second-line drugs that are less potent and more toxic than those used in the clinical management of drug-susceptible TB. Moreover, treatment outcomes for MDR-TB are generally poor compared to drug sensit...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
PAGEPress Publications, Pavia, Italy
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4927937/ https://www.ncbi.nlm.nih.gov/pubmed/27403268 http://dx.doi.org/10.4081/idr.2016.6569 |
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author | Gualano, Gina Capone, Susanna Matteelli, Alberto Palmieri, Fabrizio |
author_facet | Gualano, Gina Capone, Susanna Matteelli, Alberto Palmieri, Fabrizio |
author_sort | Gualano, Gina |
collection | PubMed |
description | Treatment of multidrug-resistant tuberculosis (MDR-TB) cases is challenging because it relies on second-line drugs that are less potent and more toxic than those used in the clinical management of drug-susceptible TB. Moreover, treatment outcomes for MDR-TB are generally poor compared to drug sensitive disease, highlighting the need for of new drugs. For the first time in more than 50 years, two new anti-TB drugs were approved and released. Bedaquiline is a first-in-class diarylquinoline compound that showed durable culture conversion at 24 weeks in phase IIb trials. Delamanid is the first drug of the nitroimidazole class to enter clinical practice. Similarly to bedaquiline results of phase IIb studies showed increased sputum-culture conversion at 2 months and better final treatment outcomes in patients with MDR-TB. Among repurposed drugs linezolid and carbapenems may represent a valuable drug to treat cases of MDR and extensively drug-resistant TB. The recommended regimen for MDR-TB is the combination of at least four drugs to which M. tuberculosis is likely to be susceptible for the duration of 20 months. Drugs are chosen with a stepwise selection process through five groups on the basis of efficacy, safety, and cost. Clinical phase III trials on new regimen are ongoing that could prove transformative against MDR-TB, by being shorter (six months), simpler (an all-oral regimen) and safer than current standard therapy. It is fundamental that the adoption of the new drugs is done responsibly to avoid inappropriate use. Concentration of in-patient MDR-TB treatment in specialized centers could be considered in countries with low numbers of cases in order to provide appropriate clinical case management and to prevent emergence of drug resistance. |
format | Online Article Text |
id | pubmed-4927937 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | PAGEPress Publications, Pavia, Italy |
record_format | MEDLINE/PubMed |
spelling | pubmed-49279372016-07-11 New Antituberculosis Drugs: From Clinical Trial to Programmatic Use Gualano, Gina Capone, Susanna Matteelli, Alberto Palmieri, Fabrizio Infect Dis Rep Review Treatment of multidrug-resistant tuberculosis (MDR-TB) cases is challenging because it relies on second-line drugs that are less potent and more toxic than those used in the clinical management of drug-susceptible TB. Moreover, treatment outcomes for MDR-TB are generally poor compared to drug sensitive disease, highlighting the need for of new drugs. For the first time in more than 50 years, two new anti-TB drugs were approved and released. Bedaquiline is a first-in-class diarylquinoline compound that showed durable culture conversion at 24 weeks in phase IIb trials. Delamanid is the first drug of the nitroimidazole class to enter clinical practice. Similarly to bedaquiline results of phase IIb studies showed increased sputum-culture conversion at 2 months and better final treatment outcomes in patients with MDR-TB. Among repurposed drugs linezolid and carbapenems may represent a valuable drug to treat cases of MDR and extensively drug-resistant TB. The recommended regimen for MDR-TB is the combination of at least four drugs to which M. tuberculosis is likely to be susceptible for the duration of 20 months. Drugs are chosen with a stepwise selection process through five groups on the basis of efficacy, safety, and cost. Clinical phase III trials on new regimen are ongoing that could prove transformative against MDR-TB, by being shorter (six months), simpler (an all-oral regimen) and safer than current standard therapy. It is fundamental that the adoption of the new drugs is done responsibly to avoid inappropriate use. Concentration of in-patient MDR-TB treatment in specialized centers could be considered in countries with low numbers of cases in order to provide appropriate clinical case management and to prevent emergence of drug resistance. PAGEPress Publications, Pavia, Italy 2016-06-24 /pmc/articles/PMC4927937/ /pubmed/27403268 http://dx.doi.org/10.4081/idr.2016.6569 Text en ©Copyright G. Gualano et al. http://creativecommons.org/licenses/by-nc/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Review Gualano, Gina Capone, Susanna Matteelli, Alberto Palmieri, Fabrizio New Antituberculosis Drugs: From Clinical Trial to Programmatic Use |
title | New Antituberculosis Drugs: From Clinical Trial to Programmatic Use |
title_full | New Antituberculosis Drugs: From Clinical Trial to Programmatic Use |
title_fullStr | New Antituberculosis Drugs: From Clinical Trial to Programmatic Use |
title_full_unstemmed | New Antituberculosis Drugs: From Clinical Trial to Programmatic Use |
title_short | New Antituberculosis Drugs: From Clinical Trial to Programmatic Use |
title_sort | new antituberculosis drugs: from clinical trial to programmatic use |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4927937/ https://www.ncbi.nlm.nih.gov/pubmed/27403268 http://dx.doi.org/10.4081/idr.2016.6569 |
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