Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects
Condition: Hepatitis C; HCV
MeSH terms: Hepatitis C; Hepatitis
Intervention: Glecaprevir/Pibrentasvir (G/P) 300mg/120mg; Ribavirin 200Mg Tablet
Intervention description: daily; Weight-based 1000-1200 mg
Intervention MeSH terms: Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Main Study Up to 225 subjects will be enrolled into 4 study arms A, B, C and D with Glecaprevir/Pibrentasvir (G/P) with or without Ribavirin (RBV).
About 75-90 non-cirrhotic subjects will be randomized in a 2:1 ratio to Arms A and B, and about 110-135 compensated cirrhotic subjects will be randomized in a 1:1 ratio to Arms C and D.
Non-cirrhotic subjects will be randomized 2:1 to:
Arm A: G/P 300 mg/120 mg Once a day for 12 weeks
Arm B: G/P 300 mg/120mg Once a day for 16 weeks
Subjects with compensated cirrhosis will be randomized 1:1 to:
Arm C: G/P 300 mg/120 mg QD + weight-based RBV (Ribavirin) Twice a day (1000 mg or 1200 mg total daily dose) for 12 weeks
Arm D: G/P 300 mg/120 mg QD for 16 weeks Retreatment sub-study Up to 11 subjects who still have hepatitis C virus after being treated in the Main study will have the option to enter the Retreatment sub-study and receive G/P plus Sofosbuvir and with or without RBV.
Masking: None (Open Label)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: HCV; Previously treated

Summary:

      The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment
      experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not
      complete the prescribed duration due to adverse event or any reason other than for non/poor
      compliance. Subjects will be randomized to 12 or 16 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female at least 18 years of age at time of screening.

          2. A history of previous treatment with an NS5A-inhibitor plus sofosbuvir therapy ± RBV
             for chronic HCV genotype 1 infection.

          3. Treatment must have been completed at least 1 month prior to Screening Visit.

          4. Screening laboratory result indicating chronic HCV GT1 infection. Subjects must be
             able to understand and adhere to the study visit schedule and all other protocol
             requirements and must voluntarily sign and date an informed consent.

        Exclusion Criteria:

          1. History of severe, life-threatening or other significant sensitivity to any drug.

          2. Female who is pregnant, planning to become pregnant during the study or breastfeeding;
             or male whose partner is pregnant or planning to become pregnant during the study.

          3. Recent (within 6 months prior to study drug administration) history of drug or alcohol
             abuse that could preclude adherence to the protocol in the opinion of the
             investigator.

          4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or
             anti-human immunodeficiency virus antibody (HIV Ab) in patient without known history
             of HIV infection.

          5. HCV genotype performed during screening indicating co-infection with more than one HCV
             genotype.

          6. History or presence of liver decompensation.