•The purpose of this study is to compare the performance between liver biopsy and non-invasive fibrosis assessments evaluating anti-fibrotic efficacy of peginterferon plus ribavirin in patients with hepatitis C pre- and post-treatment
* Patients with histologically advanced hepatitis C receiving peginterferon plus ribavirin combination therapy have showed 30-40% of a sustained virologic response (SVR) rate and 50% of histologic improvement. * The histologic change of liver is the most important prognosticator to predict further clinical outcomes in advanced hepatitis C patients following peginterferon-based antiviral therapy. * Although liver biopsy remains the gold standard for histologic assessment, it has several shortcomings in terms of poor repeatability due to its invasiveness and poor reproducibility due to sampling error and intra- or inter-observer variability. * Treatment-naïve patients with chronic hepatitis C will receive PEGASYS® 180 mcg once weekly and ribavirin twice daily for 24 or 48 weeks depending on the genotype of hepatitis C virus (HCV). * All subjects will be followed for up to 48 weeks after treatment cessation. * Liver biopsy will be done at baseline and the end of follow-up for the evaluation of histologic response. * Noninvasive tests for liver fibrosis (ARFI elastography, APRI, FIB-4, FibroTest®, and ELF test) will be assessed per 24 weeks during the whole study period. * The results of this study will provide insight into the histo-physical link between histologic changes and liver stiffness dynamics during and after peginterferon alpha-2a plus ribavirin treatment in patients with advanced hepatitis C. * Therefore, noninvasive fibrosis assessments may be useful to trace fibrosis outcomes in patients with advanced hepatitis C receiving antiviral therapy.
Study Type
OBSERVATIONAL
Enrollment
55
acoustic radiation force impulse ultrasonography
Seoul Metropolitan Government Boramae Medical Center
Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, South Korea
Anti-fibrotic response
Anti-fibrotic response, indicated by a lack of histological worsening, defined as the stabilization or the improvement of at least one stage in the histologic fibrosis staging 48 weeks after the end of treatment
Time frame: 48 weeks after the end of treatment
Histologic and noninvasive fibrosis assessments
* Liver fibrosis score(according to the viral genotype or virologic response) * Morphometric analysis of fibrosis surface area * Acoustic radiation force impulse (ARFI) ultrasound imaging and clinical fibrosis indices (APRI, FIB-4, FibroTest®, and ELF test) * Noninvasive tests using the tissue shear wave speed and clinical fibrosis indices
Time frame: 48 weeks after the end of treatment
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