ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis
Condition: Chronic Hepatitis C Virus (HCV)
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Fibrosis
Intervention: ABT-450/r/ABT-267; ABT-333; ribavirin
Intervention description: Tablet; Tablet; Tablet
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: HCV Infection; Compensated Cirrhosis

Summary:

      This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of
      ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b,
      treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV treatment-experienced
      Asian adults with compensated cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and
             Taiwanese parentage.

          2. Chronic HCV-infection prior to study enrollment.

          3. Screening laboratory result indicating HCV genotype 1b-infection.

          4. Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at
             Screening.

          5. Per local standard practice, documentation of cirrhosis by one of the following
             methods:

               -  Diagnosis on previous liver biopsy or liver biopsy conducted during screening
                  e.g., Metavir Score of > 3 (including 3/4 or 3 - 4), Ishak score of > 4 or,

               -  FibroScan score ≥ 14.6 kiloPascals (kPa) within 6 months of Screening or during
                  the Screening Period.

        Exclusion Criteria:

          1. HCV genotype performed during screening indicating unable to genotype or infection
             with any other HCV genotype.

          2. Positive test result at Screening for Hepatitis B surface antigen (HBsAg), or
             hepatitis B virus (HBV) DNA > Lower Limit of Quantification (LLOQ) if HBsAg negative,
             or anti-Human Immunodeficiency virus antibody (HIV Ab).

          3. Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of
             CYP2C8 within 2 weeks or within 10 half-lives, whichever is longer, of the respective
             medication/supplement prior to study drug administration.

          4. Any current or past clinical evidence of Child-Pugh B or C classification or clinical
             history of liver decompensation including ascites (noted on physical exam), variceal
             bleeding, or hepatic encephalopathy.

          5. Serum Alpha-Fetoprotein (sAFP) > 100 ng/mL at Screening.

          6. Confirmed presence of hepatocellular carcinoma (HCC) indicated on imaging techniques
             such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3
             months prior to Screening or on an ultrasound performed at Screening (a positive
             ultrasound result should be confirmed with CT scan or MRI.)

          7. Any primary cause of liver disease other than chronic HCV-infection, including but not
             limited to the following:

               -  Hemochromatosis

               -  Alpha-1 antitrypsin deficiency

               -  Wilson's disease

               -  Autoimmune hepatitis

               -  Alcoholic liver disease

               -  Drug-related liver disease Steatosis and steatohepatitis on a liver biopsy
                  coincident with HCV-related changes would not be considered exclusionary unless
                  the steatohepatitis is considered to be the primary cause of the liver disease.

          8. Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic
             function.