A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Carcinoma; Carcinoma, Hepatocellular; Hepatitis; Hepatitis, Chronic
Intervention: ombitasvir/paritaprevir/ritonavir and dasabuvir; ombitasvir/paritaprevir/ritonavir; ribavirin
Intervention description: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet; Tablet; ombitasvir coformulated with paritaprevir and ritonavir; 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: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C Infection; Early Stage Hepatocellular Carcinoma

Summary:

      The purpose of this study is to evaluate the safety and efficacy of
      ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered
      with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or
      genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with
      compensated cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, at least 18 years of age at time of screening

          2. Chronic hepatitis C virus (HCV) infection prior to study enrollment with screening
             laboratory results indicating HCV genotype 1 or 4 infection

          3. Early stage hepatocellular carcinoma (HCC) diagnosed based on the typical hallmark of
             HCC (hypervascular in the arterial phase with washout in the portal venous or delayed
             phases)

          4. Compensated cirrhosis defined as a Child-Pugh score of 5 or 6 at Screening

             • A minimal rim of ascites if detected at imaging is acceptable. Exclude ascites that
             requires the need to apply diuretic treatment to control ascites

          5. Documented complete response to HCC treatment.

          6. Females must be post-menopausal for more than 2 years or surgically sterile or
             practicing acceptable forms of birth control.

        Exclusion Criteria:

          1. Use of known strong or moderate inducers of cytochrome P450 3A (CYP3A) in participants
             receiving ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) with and without dasabuvir
             (DSV), strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8
             (CYP2C8) in participants receiving OBV/PTV/r with DSV, medications contraindicated for
             ritonavir or RBV (for those that receive RBV) within 2 weeks or 10 half-lives (if
             known), whichever is longer, prior to study drug . For medications contraindicated
             with AbbVie's 2-direct-acting antiviral agent (2-DAA) and 3-DAA regimen, refer to the
             recommended prescribing information section of the approved local product labels.

          2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human
             immunodeficiency virus antibody (HIV Ab).

          3. Patients regardless of eligibility to liver transplant, who have a comorbid disease
             that might preclude completion of study follow-up.

          4. Clinically significant abnormalities, other than HCV infection, in a participant with
             HCC based upon the medical history, physical examination, vital signs, laboratory
             profile and a 12-lead electrocardiogram (ECG) that make the participant an unsuitable
             candidate for this study in the opinion of the investigator.