Biotest 988 Civacir

Inclusion Criteria:

• Written informed consent obtained prior to any study-specific assessments and within 3 months (reconsent) of orthotopic liver transplantation (OLT).
• HCV Genotype 1 through 6 Infection.
• Subjects in the beginning of a new antiviral therapy regimen (regardless of prior treatment failures) for up to and including 24 weeks prior to the day of OLT.
• Most recent evidence within the last 4 weeks that HCV RNA is <100 IU/mL. Subjects may be randomized based on local lab HCV RNA.
• Male and female subjects (age 18-80 years).
• Subject weight under 250 pounds.
• Stable patient in a condition which in the opinion of the investigator would permit safe participation in the study.

Exclusion Criteria:

• Re-transplantation due to viral recurrence.
• Positive HIV or HBV test within 90 days prior to transplantation.
• Most recent PCR test indicating HCV RNA ≥100 IU/mL within 4 weeks of OLT.
• Subjects having received organs from HCV positive donors.
• Serum creatinine level >2.5 times the upper limit of normal or advanced renal disease at screening.
• Pregnancy or single contraceptive measure or lactation period (females only).
• Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction).
• Known absolute Immunoglobulin A (IgA) deficiency.
• Known intolerance to proteins of human origin.
• Participation in another clinical trial within 90 days before signing Informed Consent Form (ICF) or during the study (observational/ non-interventional and 988 studies allowed), and/or previous participation in 988 study (except for Study 988 screen failures).
• Active drug and/or alcohol abuse.
• Inability or lacking motivation to participate in the study.