Significance of a reduction in HCV RNA levels at 4 and 12 weeks in patients infected with HCV genotype 1b for the prediction of the outcome of combination therapy with peginterferon and ribavirin

BMC Infectious Diseases

Research Article

Tatsuya Ide¹  Michio Sata¹  Hidenori Toyoda²  Takashi Kumada²  Koichi Takaguchi³  Hiroyuki Ginba⁴  Kazuhiro Matsuyama⁴  Namiki Izumi⁵  Noritomo Shimada⁶ 

[1] Department of Digestive Disease Information and Research, Kurume University School of Medicine, Kurume, Japan;Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan;Department of Internal Medicine, Kagawa Prefectural Central Hospital, Takamatsu, Japan;Department of Life Cycle Management, Roche Diagnostics Japan K.K, Tokyo, Japan;Division of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Musashino, Japan;Division of Gastroenterology and Hepatology, Shinmatsudo Central General Hospital, Matsudo, Japan;

关键词: Chronic hepatitis C;    Peginterferon;    Ribavirin;    Reduction in HCV RNA levels;    Four and twelve weeks;    Baseline factors;    Response-guided therapy;    Extended treatment;   

DOI  :  10.1186/1471-2334-12-324

 received in 2012-08-02, accepted in 2012-11-17,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundThe importance of the reduction in hepatitis C virus (HCV) RNA levels 4 and 12 weeks after starting peginterferon (PEG-IFN) and ribavirin combination therapy has been reported to predict a sustained virologic response (SVR) in patients infected with HCV genotype 1. We conducted a multicenter study to validate this importance along with baseline predictive factors in this patient subpopulation.MethodsA total of 516 patients with HCV genotype 1 and pretreatment HCV RNA levels ≥5.0 log10 IU/mL who completed response-guided therapy according to the AASLD guidelines were enrolled. The reduction in serum HCV RNA levels 4 and 12 weeks after starting therapy was measured using real-time PCR, and its value in predicting the likelihood of SVR was evaluated.ResultsThe area under the receiver operating characteristics (ROC) curve was 0.852 for 4-week reduction and 0.826 for 12-week reduction of HCV RNA levels, respectively. When the cut-off is fixed at a 2.8-log10 reduction at 4 weeks and a 4.9-log10 reduction at 12 weeks on the basis of ROC analysis, the sensitivity and specificity for SVR were 80.9% and 77.9% at 4 weeks and were 89.0% and 67.2% at 12 weeks, respectively. These variables were independent factors associated with SVR in multivariate analysis. Among 99 patients who showed a delayed virologic response and completed 72-week extended regimen, the area under ROC curve was low: 0.516 for 4-week reduction and 0.482 for 12-week reduction of HCV RNA levels, respectively.ConclusionsThe reduction in HCV RNA levels 4 and 12 weeks after starting combination therapy is a strong independent predictor for SVR overall. These variables were not useful for predicting SVR in patients who showed a slow virologic response and experienced 72-week extended regimen.

【 授权许可】

Unknown   
© Toyoda et al.; licensee BioMed Central Ltd. 2012. 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.