NIDDM and IR in Combination Therapy for CHC
NIDDM and IR in Combination Therapy for CHC
The influence of insulin sensitivity and glucose tolerance on the effects of antiviral
 therapy for HCV remains unclear. The aim of the present study was (1) To elucidate the
 clinical and virological factors associated with sustained viral response in patients with
 combination therapy with PEG-IFN and ribavirin. (2) To clarify the influence of diabetes
 mellitus (DM), impaired glucose tolerance test (IGT) and insulin resistance (IR) on the HCV
 response to combination therapy with PEG-IFN and ribavirin. (3) To test the influence of
 combination therapy on HOMA IR
Total 300 treatment-naïve chronic hepatitis C patients will be enrolled. The prevalence of
 NIDDM, IGT and IR will be explored in this hospital-based study among the clinically defined
 chronic hepatitis C Taiwanese. The clinical manifestations of chronic hepatitis C in the
 biochemical, virological and histopathological aspects will be evaluated. Liver enzymes will
 be measured on a multichannel autoanalyzer. Virological markers for HCV including serum HCV
 RNA detected using a standardized automated qualitative PCR assay, HCV RNA genotypes
 determined for genotypes 1a, 1b, 2a, 2b and 3a and serum HCV RNA levels measured by using the
 branched DNA assay. The liver histology will be assessed for scoring the disease activity
 grade quantitatively according to the histological activity index (HAI). Patients are
 assigned a diagnosis of DM if there was documented use of oral hypoglycemic medication or
 insulin, random glucose in excess of 200 mg/dL, or fasting glucose greater than 126 mg/dL on
 two occasions. A standard oral glucose tolerance test (OGTT) will be performed. In addition
 to an OGTT, a history of diabetes mellitus by chart review and/or questionnaire will be also
 obtained. Standard antiviral therapy will be carried out with PEG-IFN, given subcutaneously
 weekly plus 1,000-1,200 mg of oral ribavirin daily. Patients will receive another 24 week of
 follow-up period to determine the virological response.
Inclusion Criteria:

 1. Chronic hepatitis C patients with positive anti-HCV for more than 6 months and HCV RNA

 2. No overt hepatic failure or decompensated liver cirrhosis (Child-Pugh class B or C) or
 hepatocellular carcinoma.

 Exclusion Criteria:

 1. Positive for hepatitis B surface antigen (HBsAg)or with concomitant human
 immunodeficiency virus infection

 2. With other types of hepatitis including autoimmune hepatitis, primary biliary
 cirrhosis, sclerosing cholangitis, Wilson's disease, alpha 1-antitrypsin deficiency

 3. Current or past history of alcohol abuse (80 mL ethanol per day)