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Short versus standard treatment with pegylated interferon alfa-2A plus ribavirin in patients with hepatitis C virus genotype 2 or 3: the cleo trial
BACKGROUND: In patients with chronic hepatitis C virus (HCV) genotype 2 or 3, 24 weeks' treatment with pegylated interferon alfa (PEG-IFN-alpha) and ribavirin induces a sustained virological response (SVR) in almost 80% of cases. Evidence suggests that a similar response rate may be obtained wi...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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BioMed Central
2010
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2837223/ https://www.ncbi.nlm.nih.gov/pubmed/20170514 http://dx.doi.org/10.1186/1471-230X-10-21 |
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author | Mecenate, Fabrizio Pellicelli, Adriano M Barbaro, Giuseppe Romano, Mario Barlattani, Angelo Mazzoni, Ettore Bonaventura, Maria Elena Nosotti, Lorenzo Arcuri, Pasquale Picardi, Antonio Barbarini, Giorgio D'Ambrosio, Cecilia Paffetti, Amerigo Andreoli, Arnaldo Soccorsi, Fabrizio |
author_facet | Mecenate, Fabrizio Pellicelli, Adriano M Barbaro, Giuseppe Romano, Mario Barlattani, Angelo Mazzoni, Ettore Bonaventura, Maria Elena Nosotti, Lorenzo Arcuri, Pasquale Picardi, Antonio Barbarini, Giorgio D'Ambrosio, Cecilia Paffetti, Amerigo Andreoli, Arnaldo Soccorsi, Fabrizio |
author_sort | Mecenate, Fabrizio |
collection | PubMed |
description | BACKGROUND: In patients with chronic hepatitis C virus (HCV) genotype 2 or 3, 24 weeks' treatment with pegylated interferon alfa (PEG-IFN-alpha) and ribavirin induces a sustained virological response (SVR) in almost 80% of cases. Evidence suggests that a similar response rate may be obtained with shorter treatment periods, especially in patients with a rapid virological response (RVR). The aim of this study was to compare the efficacy of 12 or 24 weeks of treatment in patients with chronic HCV genotype 2 or 3 and to identify patients suitable for 12 weeks treatment. METHODS: Two hundred and ten patients received PEG-IFN-alpha-2a (180 ug/week) and ribavirin (800-1200 mg/day) for 4 weeks. Patients with a RVR (HCV RNA not detectable) were randomized (1:1) to either 12 (group A1) or 24 (group A2) weeks of combination therapy. Patients without a RVR continued with 24-weeks' combination therapy (group B). HCV RNA was monitored at weeks 4, 8, 12, and 24, and at week 24 post-treatment. RESULTS: At study end, end of treatment response (ETR) was observed in 62 (86%) patients of group A1 and in 55 (77%) patients of group A2 (p < 0.05) Relapse rate was 3% each in groups A1 and A2, and 6% in group B. Among patients with a HCVRNA test 24 weeks after the end of treatment, SVR was observed in 60 (83%) of group A1 patients and in 53 (75%) of group A2 patients. Rapid virological response, low baseline HCV RNA levels, elevated alanine aminotransferase levels and low fibrosis score, were the strongest covariates associated with SVR, independent of HCV genotype. No baseline characteristic was associated with relapse. CONCLUSION: In HCV patients with genotype 2 or 3, 12-week combination therapy is as efficacious as 24-week therapy and several independent covariates were predictive of SVR. TRIAL REGISTRATION: Trial number ISRCTN29259563 |
format | Text |
id | pubmed-2837223 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-28372232010-03-13 Short versus standard treatment with pegylated interferon alfa-2A plus ribavirin in patients with hepatitis C virus genotype 2 or 3: the cleo trial Mecenate, Fabrizio Pellicelli, Adriano M Barbaro, Giuseppe Romano, Mario Barlattani, Angelo Mazzoni, Ettore Bonaventura, Maria Elena Nosotti, Lorenzo Arcuri, Pasquale Picardi, Antonio Barbarini, Giorgio D'Ambrosio, Cecilia Paffetti, Amerigo Andreoli, Arnaldo Soccorsi, Fabrizio BMC Gastroenterol Research Article BACKGROUND: In patients with chronic hepatitis C virus (HCV) genotype 2 or 3, 24 weeks' treatment with pegylated interferon alfa (PEG-IFN-alpha) and ribavirin induces a sustained virological response (SVR) in almost 80% of cases. Evidence suggests that a similar response rate may be obtained with shorter treatment periods, especially in patients with a rapid virological response (RVR). The aim of this study was to compare the efficacy of 12 or 24 weeks of treatment in patients with chronic HCV genotype 2 or 3 and to identify patients suitable for 12 weeks treatment. METHODS: Two hundred and ten patients received PEG-IFN-alpha-2a (180 ug/week) and ribavirin (800-1200 mg/day) for 4 weeks. Patients with a RVR (HCV RNA not detectable) were randomized (1:1) to either 12 (group A1) or 24 (group A2) weeks of combination therapy. Patients without a RVR continued with 24-weeks' combination therapy (group B). HCV RNA was monitored at weeks 4, 8, 12, and 24, and at week 24 post-treatment. RESULTS: At study end, end of treatment response (ETR) was observed in 62 (86%) patients of group A1 and in 55 (77%) patients of group A2 (p < 0.05) Relapse rate was 3% each in groups A1 and A2, and 6% in group B. Among patients with a HCVRNA test 24 weeks after the end of treatment, SVR was observed in 60 (83%) of group A1 patients and in 53 (75%) of group A2 patients. Rapid virological response, low baseline HCV RNA levels, elevated alanine aminotransferase levels and low fibrosis score, were the strongest covariates associated with SVR, independent of HCV genotype. No baseline characteristic was associated with relapse. CONCLUSION: In HCV patients with genotype 2 or 3, 12-week combination therapy is as efficacious as 24-week therapy and several independent covariates were predictive of SVR. TRIAL REGISTRATION: Trial number ISRCTN29259563 BioMed Central 2010-02-19 /pmc/articles/PMC2837223/ /pubmed/20170514 http://dx.doi.org/10.1186/1471-230X-10-21 Text en Copyright ©2010 Mecenate et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Mecenate, Fabrizio Pellicelli, Adriano M Barbaro, Giuseppe Romano, Mario Barlattani, Angelo Mazzoni, Ettore Bonaventura, Maria Elena Nosotti, Lorenzo Arcuri, Pasquale Picardi, Antonio Barbarini, Giorgio D'Ambrosio, Cecilia Paffetti, Amerigo Andreoli, Arnaldo Soccorsi, Fabrizio Short versus standard treatment with pegylated interferon alfa-2A plus ribavirin in patients with hepatitis C virus genotype 2 or 3: the cleo trial |
title | Short versus standard treatment with pegylated interferon alfa-2A plus ribavirin in patients with hepatitis C virus genotype 2 or 3: the cleo trial |
title_full | Short versus standard treatment with pegylated interferon alfa-2A plus ribavirin in patients with hepatitis C virus genotype 2 or 3: the cleo trial |
title_fullStr | Short versus standard treatment with pegylated interferon alfa-2A plus ribavirin in patients with hepatitis C virus genotype 2 or 3: the cleo trial |
title_full_unstemmed | Short versus standard treatment with pegylated interferon alfa-2A plus ribavirin in patients with hepatitis C virus genotype 2 or 3: the cleo trial |
title_short | Short versus standard treatment with pegylated interferon alfa-2A plus ribavirin in patients with hepatitis C virus genotype 2 or 3: the cleo trial |
title_sort | short versus standard treatment with pegylated interferon alfa-2a plus ribavirin in patients with hepatitis c virus genotype 2 or 3: the cleo trial |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2837223/ https://www.ncbi.nlm.nih.gov/pubmed/20170514 http://dx.doi.org/10.1186/1471-230X-10-21 |
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