A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis
Condition: Chronic Hepatitis C Infection; Compensated Cirrhosis
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Intervention: Ombitasvir/Paritaprevir/Ritonavir; Dasabuvir
Intervention description: Tablet; paritaprevir co-formulated with ritonavir and ombitasvir; Tablet
Intervention MeSH terms: Ritonavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C; Chronic Hepatitis C; Compensated Cirrhosis; Cirrhotic; Hepatitis C Genotype 1b; Hepatitis C Virus; Interferon-Free; Child Pugh A; Ribavirin-Free

Summary:

      The purpose of this study was to evaluate the safety and efficacy of ombitasvir/
      paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus
      (HCV) infection and cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is
             defined as the following:

               -  Positive for anti-HCV antibody (Ab) or HCV RNA > 1,000 IU/mL at least 6 months
                  before Screening, and positive for HCV RNA and anti-HCV Ab at the time of
                  Screening; or

               -  HCV RNA > 1,000 IU/mL at the time of Screening with a liver biopsy consistent
                  with chronic HCV-infection (or a liver biopsy performed prior to enrollment with
                  evidence of chronic hepatitis C disease).

          2. Screening laboratory result indicating HCV genotype 1b-infection.

          3. Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.

        Exclusion Criteria:

          1. Women who are pregnant or breastfeeding.

          2. Positive test result for Hepatitis B surface antigen (HBsAg) or positive human
             immunodeficiency virus (HIV) antibody (confirmed by Western Blot).

          3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical
             history of liver decompensation such as ascites (noted on physical exam), variceal
             bleeding, or hepatic encephalopathy.

          4. Confirmed presence of hepatocellular carcinoma 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 will be confirmed with CT scan or MRI.)

          5. Use of contraindicated medications within 2 weeks of dosing

          6. Screening laboratory analyses showing any of the following abnormal laboratory
             results:

               -  Calculated creatinine clearance (using Cockcroft-Gault method) < 30 mL/min

               -  Albumin < 2.8 g/dL

               -  International normalized ratio (INR) > 1.8. Participants with a known inherited
                  blood disorder and INR > 1.8 may be enrolled with permission of the AbbVie Study
                  Designated Physician.

               -  Hemoglobin < 10 g/dL

               -  Platelets < 25,000 cells per mm3

               -  Total bilirubin > 3.0 mg/dL