Paroxetine for the Treatment of Interferon Related Side Effects for Hepatitis C

Inclusion Criteria: * age 18-65 years including males, females and minorities * serum positive for either anti-HCV antibodies or HCV-RNA positive by PCR * compensated liver disease with the following minimum hematologic and biochemical criteria: hemoglobin 3 g/dl for males; 12 g/dl for females, white blood cell count \> 3,000/mm3, neutrophil count \>1,5000/mm3, platelets \> 100,000/mm3, prothrombin time 2 seconds prolonged compared to control, or equivalent INR ratio, albumin stable and within normal limits, serum creatinine within normal limits, thyroid-stimulating hormone (TSH) within normal limits, direct bilirubin 0.3 mg/dl or within 20% of upper limit of normal (ULN) for local laboratory, indirect bilirubin 0.8 mg/dl or within 20% of ULN for local laboratory, fasting blood sugar 115 mg/dl or within 20% of ULN for non-diabetic patients * serum hepatitis B surface antigen (HbsAg) negative, antinuclear antibodies (ANA) 1:320 * normal pre-therapy ocular examination if a history of diabetes or hypertension * hemoglobin A1C \<8.5% if a history of diabetes * negative pregnancy test for women of childbearing potential, and consent to adhere to adequate contraception or monogamous relationship with a male partner who has had a vasectomy during the treatment period and for 6 months after discontinuation of therapy * not breast feeding * documentation and confirmation of adequate contraception in sexually active males * free from all psychotropic medications for a minimum of 14 days prior to baseline visit (8 weeks for fluoxetine) Exclusion Criteria: * actively meet criteria for major depression within the past six months * active, effective treatment of depression with an antidepressant within the past three months * meet criteria for schizophrenia or bipolar disorder (mania) past or present * actively meet DSM IV criteria for substance abuse/dependence within the past six months * psychotropic medications within 14 days prior to baseline visit (8 weeks for fluoxetine) * evidence of untreated or poorly controlled endocrine, cardiovascular, hematological, renal, or neurological disease * evidence of decompensated liver disease (such as a history or presence of ascites, bleeding varices, spontaneous encephalopathy) * history of CNS trauma or active seizure disorder requiring medication * any cause for liver disease other than chronic hepatitis C, such as co-infection with hepatitis B virus and/or human immunodeficiency virus, hemochromatosis, or Wilson's disease * prior treatment with other (other than IFN-alpha or ribavirin) immunomodulatory drugs, including corticosteroids within 6 months of entry into protocol * clinical gout * known hypersensitivity to alpha interferon or ribavirin * hemoglobinopathies (e.g. thalassemia) * a positive pregnancy test * clinically significant retinal abnormalities * organ transplants * a score of \<24 on the Mini Mental Status Exam (MMSE) * prior history of severe adverse events associated with paroxetine * any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol