Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients

• INCLUSION CRITERIA:

Age greater than or equal to 18 years.

Documentation of HIV-1 infection by any licensed ELISA test and confirmed by a Western Blot.

Documentation of Hepatitis C infection by demonstration of a positive test for hepatitis C antibody.

HCV RNA level greater than 2000 IU/ml by bDNA.

Infected with HCV genotype 1.

Histopathologic features consistent with chronic hepatitis C on liver biopsy at the time of enrollment.

Patients with CD4 greater than 300 cells/mm(3).

Ability to sign informed consent and willingness to comply with the study requirements and clinic policies.

Serum creatinine less than 1.5 mg/dL.

Serum phosphorus greater than or equal to 2.2 mg/dL (normal range NIH 2.3-4.3 mg/dL).

Neutrophil count greater than or equal to 1000 cells/mm(3).

Platelets greater than or equal to 75,000/mm(3).

Hemoglobin greater than or equal to 8.0 mg/dL.

ALT less than 7 times the NIH upper limit of normal.

Serum lipase less than 1.5 times the NIH upper limit of normal.

Not pregnant or breast-feeding. Pregnancy test must be negative within two weeks prior to dosing with study medications.

If capable of pregnancy: use of effective contraception during study: effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap or sponge, or use of hormonal contraception with an anti-HIV regimen that will not alter metabolism of hormonal contraception. This is advised on the basis of using ribavirin, which may have a potential teratogenic effect in pregnant women.

Need to have a primary doctor outside OP8 who will be taking care of the patients for their HIV infection and liver disease.

Willing to designate a person for durable power of attorney on the NIH form for medical research and medical care purposes at the NIH Clinical Center.

Ability to learn how to safely inject medication subcutaneously.

EXCLUSION CRITERIA

PT-INR (in the absence of anti-cardiolipin antibody) prolonged by greater than 2 seconds.

Organ transplant recipient.

Elevated alpha-fetoprotein level (greater than 100 ng/mL).

Coexisting neoplastic disease requiring cytotoxic therapy.

Child Pugh's class B.

Severe cardiac or pulmonary decompensation.

Severe liver decompensation or advanced cirrhosis patients.

Severe psychiatric disorder that would interfere with the adherence to protocol requirements.

Preexisting autoimmune disorders including inflammatory bowel diseases, psoriasis, and optic neuritis.

Preexisting uncontrolled seizure disorder.

Severe retinopathy.

Hemoglobinopathy

Direct bilirubin more than or equal to 2 times ULN.

No patients using long term systemic corticosteroids, immunosuppressives, or cytotoxic agents within 60 days of enrollment into the trial.

Chronic viral hepatitis of any other etiology other than hepatitis C.

Active systemic infections other than hepatitis C and HIV.

Liver disease caused by reasons other than hepatitis C like HBV, HDV, Wilson's hemochromatosis, autoimmune hepatitis (ANA greater than 160) except history of drug-associated hepatitis with discontinuation of the causative agent.

Hepatic mass suggestive of hepatocellular carcinoma.

Current alcohol or substance abuse that potentially could interfere with patient compliance.

Significant heart failure.

Evidence of esophageal varices.

Any systemic illness that will make it unlikely that the subject will be able to return to NIH for the required study visits.

Evidence of gastrointestinal malabsorption or chronic nausea or vomiting.

Male partners of pregnant women.

Currently taking didanosine (ddl or Videx-EC or Videx) as part of antiretroviral regimen.