Reducing Depressive Symptoms During HCV Therapy: A Randomized Study

Inclusion Criteria:

• Eligibility and interest in treatment for chronic HCV (Hepatitis C).
• Absence of co-infection of HIV or Hepatitis B.
• Age 25-68 years old.
• No treatment with IFN (interferon-alpha) in the past 6 months.
• Residence within a 3-hour drive of the clinic.

Exclusion Criteria:

• Patients must be willing to undergo treatment with PEG-interferon and ribavirin. They must be aware of the side effects of treatment and be motivated to self-administer the medications and come to regularly scheduled appointments.
• Patients with diabetes mellitus must have good glycemic control. Their Hgb A1 c must be <8.0%.
• Patients must not have an active malignancy.
• If patients have a history of severe psychiatric illness or are found to have one by screening with the CES-D, a psychiatrist must approve treatment. If the psychiatric problem is minor, it can be managed by the primary care physician or hepatitis C provider.
• Autoimmune disease, such as autoimmune hepatitis, systemic lupus erythematosis, or sarcoidosis, is a contraindication to treatment.
• Active alcohol or intravenous drug use is a contraindication to treatment.
• Patients with a seizure disorder muct be seizure-free for 6 months prior to treatment.
• Patients with a known history of coronary heart disease are excluded.
• Patients with complications of cirrhosis may not be treatment candidates. Those who have a platelet count of <50,000, large esophageal varices (grade 3-4), uncontrolled ascites, or uncontrolled encephalopathy are excluded.
• Patients with severe mental retardation or dementia are excluded because of difficulty in self-administration of medication and in tolerating the side effects.
• The patient and partner much agree to observe strict contraception to avoid pregnancy, since the medication is fetotoxic up to 6 months after treatment completion.