Treatment of Hepatitis C in Hemophilic Patients With HIV

Inclusion Criteria Hemophilia A or B Exposure to blood or blood products prior to 1987 Participating in "The Second Multicenter Hemophilia Cohort Study (MHCS-II)" HCV reactive by second/third generation ELISA assay and/or RIBA HCV RNA positive (PCR or bDNA methods) Chronic hepatitis confirmed by liver biopsy within 6 months prior to study entry (Note: cirrhosis is not an exclusion factor) HIV infection for coinfected group; HIV viral load of 10,000 copies/ml or less If on antiretroviral drugs, stable regimen for at least 8 weeks prior to study entry Acceptable methods of contraception Exclusion Criteria Hemoglobin less than 10 g/dl For HIV coinfected group, CD4 count less than 200 cells/mm3 at time of screening visit Previous interferon or ribavirin therapy Corticosteroids or immunomodulatory drugs within 3 months prior to study entry Hepatitis B (HBsAg reactive) Alpha-1 antitrypsin deficiency Wilson's disease Hemochromatosis Autoimmune disorder Decompensated liver disease evidenced by encephalopathy, ascites, or variceal bleed Prothrombin Time greater than 3 seconds above normal (International Normalized Ratio [INR] greater than 1.3) Platelet count less than 90,000/microL Active thyroid disease (thyroid replacement with normal TSH permitted) Chronic renal insufficiency, defined as creatinine greater than 1.5 mg/dl Life-threatening disease processes that could preclude completion of trial Alcohol abuse that the local investigator feels would interfere with compliance Illicit recreational drug use or methadone use within 6 months of study entry Major depression with hospitalization or suicide attempt is a relative, but not absolute, contraindication to therapy based on timing, circumstances, and current stability as assessed by the investigator Pregnant or breastfeeding