Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Sofosbuvir; Glecaprevir/Pibrentasvir; Ribavirin
Intervention description: Tablet for oral administration; Coformulated tablet for oral administration; Tablet for oral administration
Intervention MeSH terms: Ribavirin; Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 12 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C (HCV); HCV Genotype 1 (HCV GT1); HCV Genotype 2 (HCV GT2); HCV Genotype 3 (HCV GT3); HCV Genotype 4 (HCV GT4); HCV Genotype 5 (HCV GT5); HCV Genotype 6 (HCV GT6); Compensated Cirrhosis; Non-cirrhotics; Virologic failure

Summary:

      The purpose of this study was to evaluate the efficacy and safety of co-administration of
      glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in
      hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic,
      or cirrhotic with compensated cirrhosis participants) who had experienced virologic failure
      in an AbbVie parent clinical study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects must be adults (18 years of age or older) or adolescents (12
             to less than 18 years of age weighing at least 35 kg).

          -  Subject must have experienced virologic failure during or after treatment with
             ABT-493/ABT-530 in an AbbVie HCV parent study. Subjects who have experienced virologic
             failure during or after receiving ombitasvir/paritaprevir/r + dasabuvir (3D), or
             ombitasvir/paritaprevir/r (2D) in an AbbVie HCV parent study may be enrolled at
             AbbVie's discretion. Treatment in the parent study must have been completed or
             discontinued at least 1 month prior to the Screening Visit.

          -  Subjects must be able to understand and adhere to the study visit schedule and all
             other protocol requirements.

          -  Cirrhotic subjects must have compensated cirrhosis, (Child-Pugh score of ≤ 6) at
             Screening and no current or past evidence of Child-Pugh B or C Classification or no
             clinical history of liver decompensation, including ascites noted on physical exam,
             hepatic encephalopathy or esophageal variceal bleeding.

          -  Cirrhotic subjects must have absence of hepatocellular carcinoma (HCC) as indicated by
             a negative ultrasound (US), computed tomography (CT) scan or magnetic resonance
             imaging (MRI) within 3 months prior to Screening or a negative US at Screening.

        Exclusion Criteria:

          -  History of severe, life-threatening or other clinically significant sensitivity to any
             study drug or drug component.

          -  Female subject who is pregnant, breastfeeding or is considering becoming pregnant
             during the study or for 4 months after the last dose of study drug, or as directed per
             the local RBV label, whichever is more restrictive.

          -  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.

          -  Positive test result at Screening for hepatitis B surface antigen (HBsAg).

          -  Screening laboratory analyses showing calculated creatinine clearance < 30 mL/min.

          -  Discontinuation from the AbbVie HCV parent study for reasons other than virologic
             failure (e.g., non-adherence, lost to follow-up, and/or the occurrence of an adverse
             event).

          -  Receipt of any HCV treatment after failing the treatment regimen in the AbbVie HCV
             parent study.