The Metabolic Profile and Adipocytokine Alterations of Patients With HCV Infection Before and After HCV Therapy
The Metabolic Profile and Adipocytokine Alterations of Patients With HCV Infection Before and After HCV Therapy
Rationale for this study:

 Correction of hypocholesteremia and insulin resistance after successful eradication of HCV by
 combination therapy of interferon and ribavirin has been shown in several studies. The
 majority of these studies examined genotype 1 and some genotype 3 patients, but it is not
 clear if the same results can be achieved in other genotypes of HCV.

 Moreover, clinical data of the relationships between different adipocytokines, metabolic
 profiles, and HCV and treatment is of value to further understand the mechanisms for
 HCVrelated metabolic alterations. The present proposal is designed to address the paradox of
 HCV-related metabolic alterations/adipocytokine alterations and to determine how BMI
 influences the HCV-related metabolic alteration/adipocytokine aterations by collecting and
 analyzing the samples from humans with HCV infection prior to and after combination of
 peginterferon alpha-2b plus ribavirin

 For metabolic alternations:

 Lipid profile: After treatment, responders in both genotype I and II will experience more
 increase of cholesterol levels and LDL levels than nonresponders/ relapseres. Insulin
 resistance: After treatment, responders with both genotype I and II will experience more
 decrease of HOMA-IR than nonresponders/ relapseres; higher percentage of responders will
 achieve HOMA-IR < 2 than nonresponders/ relapseres B. For adipocytokine alternation, this
 study is more of exploratory propose as there is still little well established consensus.
Subjects with chronic hepatitis C infections will be enrolled

 Inclusion Criteria

 1. Aged 18 y/o or older

 2. Positive for the HCV antibody and HCV RNA detected

 3. Patients with abnormal liver function OR a liver biopsy specimen taken in the 6 months
 prior to study entry showing chronic hepatitis, or liver fibrosis, or liver cihhrosis

 4. Have not been previously treated with pegylated-interferon and ribavirin for HCV

 5. Genotype 1 or Genotype 2

 Exclusion Criteria

 1. Subjects with decompensated liver disease

 2. With human immunodeficiency virus

 3. With hepatitis B infection

 4. With hemochromatosis defined by a pre-existing diagnosis of hemochromatosis or a
 positive HFE gene mutation or recipients of solid organ transplants

 5. With clinically significant cardiac or cardiovascular abnormalities, organ grafts,
 systemic infections, clinically significant bleeding disorders, evidence of malignant
 neoplastic diseases

 6. Subjects who are on lipid-lowering medications

 7. Poorly controlled Diabetes (A1C > 9%) The study will go through the CGMH IRB review and
 be posted into clinicaltrial.gov.

 This is a single centre, prospective, open-label, single arm, interventional study.
Inclusion Criteria:

 1. Aged 18 y/o or older

 2. Positive for the HCV antibody and HCV RNA detected

 3. Patients with abnormal liver function OR a liver biopsy specimen taken in the 6 months
 prior to study entry showing chronic hepatitis, or liver fibrosis, or liver cihhrosis

 4. Have not been previously treated with pegylated-interferon and ribavirin for HCV

 5. Genotype 1 or Genotype 2

 Exclusion Criteria:

 1. Subjects with decompensated liver disease

 2. With human immunodeficiency virus

 3. With hepatitis B infection

 4. With hemochromatosis defined by a pre-existing diagnosis of hemochromatosis or a
 positive HFE gene mutation or recipients of solid organ transplants

 5. With clinically significant cardiac or cardiovascular abnormalities, organ grafts,
 systemic infections, clinically significant bleeding disorders, evidence of malignant
 neoplastic diseases

 6. Subjects who are on lipid-lowering medications

 7. Poorly controlled Diabetes (A1C > 9%) -