Peripheral Blood Mononuclear Cell (PBMC) Gene Expression in HCV Genotype 1 Patients
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Our previous collaborative studies has developed a molecular diagnosis tool, which is
      characterized with a prediction model consisting single nucleotide polymorphisms (SNPs), for
      assessing the efficacy of interferon combined therapy for chronic hepatitis C (CHC) patients
      prior to treatment.

      Aims of this project:

        1. To analyze and validate the gene expression profiling dependent of treatment response to
           peg-interferon-α plus ribavirin combination therapy in CHC genotype-1 patients.

        2. To select the candidate genes and establish a monitoring model assessing the efficacy of
           interferon treatment.
    

Detailed description: 
      A combination of pegylated-interferon (PEG-IFN) with ribavirin has been the choice for
      treating chronic hepatitis C (CHC) patients. In addition to the high cost, the treatment
      takes 6 to 12 months and often brings significant adverse reactions to some patients. It
      would therefore be beneficial to include a pre-treatment evaluation and post-treatment
      monitoring system to maximize the efficacy of CHC therapy. We have established a molecular
      diagnosis tool for assessing the efficacy of interferon combined therapy for CHC patients
      prior to treatment. This diagnostic tool is characterized with a prediction model consisting
      single nucleotide polymorphisms (SNPs) strongly associated with interferon efficacy in
      treating CHC patients. The prediction model has been validated by hepatitis C samples in
      Taiwan, and it achieved 80 % accuracy, higher than the current efficacy rates. Supplemented
      with the viral genotype information would further increase the prediction accuracy to 85%.

      In this project, we aim to analyze patients' gene expression profiling during the treatment.
      The current study will focus on 30 PEG-IFN and ribavirin treated patients with HCV genotype 1
      infection. After the responding status of those patients has been confirmed, we will compare
      gene expression profiling among the different responses before and during treatment. By using
      this information, we can properly select the candidate genes, and establish a monitoring
      model with these biomarkers. This monitoring model can thus be applied to assess the efficacy
      of PEG-IFN plus ribavirin combination treatment.
    

Intervention name(s): pegylated interferon alpha 2a and plus ribavirin
Intervention type(s): Drug
Intervention description(s): pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
Other intervention name(s): PEGASYS®
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Chronic Hepatitis C; Single nucleotide polymorphisms; Sustained virological response; Peginterferon; Ribavirin