Short versus standard treatment with pegylated interferon alfa-2A plus ribavirin in patients with hepatitis C virus genotype 2 or 3: the cleo trial

BMC Gastroenterology

Research Article

Giuseppe Barbaro¹  Maria Elena Bonaventura²  Amerigo Paffetti³  Lorenzo Nosotti⁴  Antonio Picardi⁵  Giorgio Barbarini⁶  Mario Romano⁷  Ettore Mazzoni⁸  Arnaldo Andreoli⁹  Cecilia D'Ambrosio⁹  Fabrizio Soccorsi⁹  Adriano M Pellicelli⁹  Angelo Barlattani^1,10  Pasquale Arcuri^1,11  Fabrizio Mecenate^1,12 

[1] Department of Medical Pathophysiology, Policlinico Umberto I, University of Rome La sapienza Rome, Italy;Division of Infectious Disease San Camillo De Lellis Hospital, Rieti, Italy;Division of Infectious disease Policlinico Umberto I Rome, Italy;IRCCS San Gallicano Hospital, Rome, Italy;Liver Unit Campus Biomedico University, Rome, Italy;Liver Unit IRCCS San Matteo, Pavia, Italy;Liver Unit Pertini Hospital, Rome, Italy;Liver Unit Policlinico Casilino, Rome, Italy;Liver Unit San Camillo Forlanini Hospital, Rome, Italy;Liver Unit San Giacomo Hospital, Rome, Italy;Liver Unit San Giovanni Hospital, Rome, Italy;Liver Unit Villa Betania Hospital, Rome, Italy;

关键词: Sustained Virological Response;    Rapid Virological Response;   

DOI  :  10.1186/1471-230X-10-21

 received in 2009-06-15, accepted in 2010-02-19,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundIn 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.MethodsTwo 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.ResultsAt 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.ConclusionIn 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 registrationTrial number ISRCTN29259563

【 授权许可】

Unknown   
© Mecenate et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. 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.