Low Dose Peginterferon and Ribavirin Therapy for Patients With Chronic Hepatitis C Infected With Genotype 2 or 3

Inclusion Criteria

- INCLUSION CRITERIA:

Age above 18 years, male or female.

Presence of anti-HCV in serum.

Positive HCV RNA determination in serum.

HCV genotype 2 or 3 as determined by Inno LiPa assay or by direct sequencing. Patients
with mixed genotypes will not be eligible if they have genotypes other than 2 or 3.

Written informed consent.

EXCLUSION CRITERIA:

Previous treatment with interferon alpha or peginterferon.

Decompensated liver disease, as marked by bilirubin greater than 4 mg/dL, albumin less
than 3.0 g/dL, prothrombin time greater than 2 sec prolonged, or history of bleeding
esophageal varices, ascites or hepatic encephalopathy.

Patients with ALT levels greater than 1000 U/L (greater than 25 times ULN) will not be
enrolled but may be followed until three determinations are below this level.

Pregnancy or, in women of child-bearing potential or in spouses of such women, inability
to practice adequate contraception, defined as vasectomy in men, tubal ligation in women,
or use of condoms and spermicidal, or birth control pills, or an intrauterine device.

Significant systemic or major illnesses other than liver disease, including congestive
heart failure, renal failure (creatinine clearance less than 50 ml/min), organ
transplantation, serious psychiatric disease not controlled by psychotropic agents, and
angina pectoris.

Evidence of coronary artery disease or cerebral vascular disease, including abnormalities
on exercise stress testing in patients with defined risk factors who will be screened for
evidence of underlying coronary artery disease.

Pre-existing, severe bone marrow compromise; anemia (hematocrit less than 30%),
neutropenia (less than 1000 neutrophils/microliter) or thrombocytopenia (less than 70,000
cells/microliter).

History of hemolytic anemia.

Evidence of another form of liver disease in addition to hepatitis C (for example
hepatitis B, autoimmune liver disease, Wilson's disease, alcoholic liver disease).

Active substance abuse, such as alcohol, inhaled or injection drugs within the previous
six months.

Evidence of hepatocellular carcinoma: either alfa-fetoprotein (AFP) levels greater than 50
ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating
a mass suggestive of liver cancer.

Clinical gout.

HIV infection.

Quiescent or active, serious autoimmune disease such as lupus erythematosus, ulcerative
colitis, Crohn's disease or rheumatoid arthritis that in the opinion of the investigators
might be exacerbated by therapy with alfa interferon.

The use of immunosuppressive medications, including corticosteroids in doses of 10 mg of
prednisone or its equivalent and higher.