Inclusion Criteria

Inclusion criteria:

- Signed written informed consent.

- Age over 18 years old.

- Presence of HCV RNA measured by qualitative PCR.

- Nonresponder to a previous course of therapy with either IFN alone or IFN plus
ribavirin. The patient must have been treated for at least 3 months (12 weeks).

- Washout period of at least 6 months from previous therapy with IFN alone or IFN plus
Ribavirin.

- Liver biopsy consistent with cirrhosis or progression to cirrhosis (METAVIR fibrosis
score 3 to 4) due to chronic hepatitis C within the last 12 months before treatment
starts, and at least 6 months after the end of the prior failed therapy.

- Cirrhosis classified as Child-Pugh "A" (no more than 6 points).

- Compensated liver disease with prothrombin time prolonged less than 3 seconds over
control, total bilirubin < 2 mg/dl, and no history of hepatic encephalopathy,
bleeding varices or a history of detection of stigmata of recent bleeding on existing
varices or ascites.

- Ultrasound, CT scan, or MRI of the liver within 3 months of entry negative for HCC.

- Hematocrit > 30%, platelet count > 75,000, WBC > 2,500, and absolute neutrophil cell
count > 1,500.

- Adequate renal function as demonstrated by serum creatinine level < 2.0 mg/dl.

- Normal TSH or adequately controlled thyroid function.

- If the patient is a woman, she is using a definitive method of birth control in
consultation with her physician, or is surgically sterile, or post-menopausal.

Exclusion criteria:

- Use of systemic corticosteroids within 6 months of entry.

- Evidence of drug-induced liver injury.

- Current use of any drug known to have or suspected of having therapeutic activity in
hepatitis C, or any immunosuppressive drug (including corticosteroids).

- Evidence of any other liver disease including hepatitis B, hepatitis delta, alcoholic
liver disease, primary biliary cirrhosis, sclerosing cholangitis, autoimmune
hepatitis, hemochromatosis, alpha 1-antitrypsin deficiency, or Wilson's disease.

- Alpha-fetoprotein > 200 ng/mL.

- Child-Pugh "B" or "C" cirrhosis (score of 7 or more points), either currently or at
any occasion in the past.

- Decompensated liver disease based on a history of hepatic encephalopathy, bleeding
varices or a history of detection of stigmata of recent bleeding on existing varices,
or ascites.

- HIV infection diagnosed by HIV seropositivity and confirmed by Western blot.

- Concomitant or prior history of malignancy other than curatively treated skin cancer
or surgically cured in situ carcinoma of the cervix.

- Active infectious process other than HCV that is not of a self-limited nature.

- Rheumatoid arthritis or other autoimmune disease (serum ANA > 1:160.).

- Pregnancy as documented by a urine pregnancy test.

- Alcohol or intravenous drug abuse within the previous 1 year.

- Chronic use of methadone.

- Patients who are poor medical risk or who have any non-malignant systemic disease
that, in the opinion of the investigator, would make it unlikely that the patient
could complete the protocol.

- Patients with a history of severe depression that required either hospitalization or
electroshock therapy; or depression associated with suicide attempt.

- Patients with significant pre-existing cardiac or pulmonary disease.

- Recipients of transplants.

- Patients with uncontrolled seizure disorder.

- Any indication that the patient would not comply with the conditions of the study
protocol.

- Previous treatment with thymosin alpha 1.

- Patients with known hypersensitivity to IFN a.

- Simultaneous participation in another investigational drug study, or participation in
any clinical trial involving investigational drugs within 3 months of study entry.

- Family history of intracerebral hemorrhage.