Effects of Low-dose Maintenance Peg Interferon Alfa-2b Therapy Versus Supportive Care in Patients With Cirrhotic Hepatitis C With HIV (Study P04371)

Inclusion Criteria

• •Age at least 18 years but \< 70 years, of either sex or any race.
• •Detectable plasma hepatitis C virus (HCV) RNA (all genotypes of HCV are permitted).
• •Cirrhosis of the liver within the last five years.
• •Compensated liver disease (Child-Pugh \<8 with hepatic encephalopathy \<= 1.
• •No evidence of hepatocellular carcinoma (HCC) and a serum alpha fetoprotein (AFP) \<100 ng/mL within two months of randomization/study enrollment.
• •Varices results via endoscopy within the last six months or at time of screening.
• •Serologic evidence of human immunodeficiency virus-1.
• •CD4 cell count \>=100 /µL.
• •Platelet number of at least 50000 mm\*\*3.
• •Neutrophil count of at least 750 mm\*\*3.
• •Hemoglobin of \>9.0 mg%.
• •Serum thyroid stimulating hormone levels within normal limits, regardless of treatment with L thyroxin.
• •Hemoglobin A1c (HbA1c)\<8.5%, to demonstrate controlled diabetes, if applicable.
• •Written clearance from an ophthalmologist must be presented for subjects with a history of hypertension or diabetes prior to treatment start.
• •Creatinine clearance \>50 mL/min, as assessed by the indirect calculation method.
• •Demonstrate stable status of HIV-1 infection.
• •On stable antiretroviral therapy (HAART) for at least 6 weeks prior to baseline, with the expectation of their HAART regimen (drugs and dosage) remaining unaltered for the first 8 weeks of the study OR
• •Willing to delay initiation of HAART therapy for at least 6 weeks (for subjects who have not been on HAART for at least 8 weeks prior to randomization). "Structured treatment interruptions" will be permitted during the study.
• •Counseled in the appropriate use of birth control while in this study, as confirmed by the principal investigator or a sub-investigator.
• •Free of any clinically significant disease (other than HCV and HIV) that would interfere with study evaluations.