An Open Label Non-Randomized Dose Escalating Trial to Assess Safety and Tolerability of Alb-Interferon Alfa 2b Every Two Weeks With Ribavirin Among HIV/HCV Coinfected Individuals

Exclusion Criteria

• •1. Patient cannot be on other experimental therapies (including expanded access/compassionate use of antiretrovirals) during his/her participation in this protocol.
• •2. Patients cannot have used interferon or peginterferon previously for the treatment of hepatitis C.
• •3. Mixed genotypes (e.g., 1/2, 1/4). Mixed genotype 1a/1b will be enrolled.
• •4. Liver histology which, in the opinion of Clinical Center pathologist, is consistent with any other co-existent cause of chronic liver disease as defined as: chronic hepatitis B with positive HBsAg autoimmune hepatitis with a positive ANA greater than 1 unit or positive anti mitochondrial antibody greater than 1 unit; cholestatic disease with persistent elevation of alkaline phosphatase; primary biliary cirrhosis or sclerosing cholangitis; Wilson's disease; alpha-1-antitrypsin deficiency; steatohepatitis (alcoholic or non alcoholic) with marked steatosis, many Mallory bodies, or extensive zone 3 periportal fibrosis.
• •6. For patients with cirrhosis, a Child Turcotte Pugh score greater than 7.
• •7. PT-INR greater than 2 or history of hemophilia or known history of Vitamin K deficiency or use of anticoagulants.
• •8. Organ transplant recipient other than cornea or hair transplant.
• •9. Estimated Creatinine clearance (eGFR) less than 50 mL/min.
• •10. A serum alpha-fetoprotein level (greater than 20 ng/mL, unless the subject has a negative ultrasound before enrollment.
• •11. For patients with history of diabetes mellitus, a HbA1C less than or equal to 7.5% and for those with a fasting blood glucose level of greater than 140mg/dL, a HbA1C of less than or equal to 7.5%.
• •12. Coexisting neoplastic disease except for Kaposi's sarcoma, any non-metastatic skin cancer that has been resected, or non-metastatic cervical or anal cancer that has been resected.
• •13. Severe cardiac disease (Grade 3 or more congestive cardiac failure, symptomatic coronary artery disease, significant arrhythmias, uncontrolled hypertension).
• •14. Severe chronic pulmonary disease with functional impairment or a DLCO less than or equal to 50% at baseline.
• •15. Severe psychiatric disorder that would interfere with the adherence to protocol requirements.
• •16. Preexisting autoimmune disorders including inflammatory bowel diseases, psoriasis, and optic neuritis.
• •17. Preexisting uncontrolled seizure disorder defined as one episode of seizure within the past 2 years.
• •18. Chronic pancreatitis.
• •19. Severe retinopathy as determined by the ophthalmologist.
• •20. Hemoglobinopathy (e.g., Thalassemia, sickle cell disease).
• •21. Currently taking didanosine or d4T as part of antiretroviral regimen.
• •22. Direct bilirubin greater than or equal to 0.6 mg/dL.
• •23. Concurrent use of any immunosuppressive therapy, including systemic steroids (prednisone equivalent of greater than 10 mg/day) for a duration of six weeks or more within six months prior to enrollment.
• •24. Concurrent use of fluticasone and high dose ritonavir (600mg t.i.d).
• •25. Chronic viral hepatitis of any other etiology other than hepatitis C.
• •26. Active systemic infections other than hepatitis C and HIV.
• •27. Liver disease caused by reasons other than hepatitis C, like HBV, HDV, Wilson's disease, hemochromatosis, autoimmune hepatitis (ANA greater than 1 unit) except history of drug-associated hepatitis with discontinuation of the causative agent.
• •28. Hepatic mass suggestive of hepatocellular carcinoma as detected by ultrasound scan.
• •29. Alcohol or substance abuse within the past 6 months that potentially could interfere with patient compliance.
• •30. Concomitant use of amphetamines, barbiturates, cocaine, ganciclovir, isoniazid, opiates, pyrazinamide, rifabutin, rifampin/rifampicin, thalidomide, and theophylline.
• •31. History of esophageal varices.
• •32. Any systemic illness that will make it unlikely that the subject will be able to return to NIH for the required study visits.
• •33. Evidence of gastrointestinal malabsorption, chronic nausea, or vomiting.
• •34. Male partners of pregnant women.
• •35. Pregnant women.
• •36. Breastfeeding women.
• •37. Hypersensitivity to interferon products or ribavirin.
• •38. Received silymarin (milk thistle) or glycyrrhizin within 28 days prior to Day 0.
• •39. Received Sho-saiko-to (SST) within 28 days prior to Day 0.
• •40. Received any other experimental agent within 28 days prior to Day 0.