Protocol M12-999: Safety and Efficacy of the Combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adult Liver Transplant Recipients with Genotype 1 Hepatitis C Virus (HCV) Infection
Location(s): United States
The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir, ABT-267 (ABT-450/r/ABT-267) and ABT-333 co-administered with ribavirin in adult liver transplant recipients with hepatitis C virus (HCV) infection.
- Liver transplantation as a consequence of HCV infection no less than 12 months before screening.
- Must have a liver biopsy which shows evidence of fibrosis <= F2 (Metavir scale) and which is obtained within the 6 months prior to the screening period but not less than 9 months post transplant or during the Screening Period
- Chronic hepatitis C genotype 1 infection.
- On an immunosuppressant regimen based on either tacrolimus or cyclosporine where the dose of immunosuppressant has not been increased at least 2 months before Screening and no new immunosuppressant drugs have been added for at leas 2 months before Screening.
- Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody.
- Use of contraindicated medications within 2 weeks of dosing or 10 half-lives, whichever is longer.
- Clinically significant abnormalities, other than HCV infection post transplant.
- Recent history of drug or alcohol abuse.
- Previous use of any investigational or commercially available anti-HCV agent other than interferon (IFN)-based therapy, i.e. conventional (c) IFN and/or pegylated (Peg) IFN, with or without RBV.