A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1)

• Status: Completed
• Trial end date: 2017-04-07
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study in HCV genotype 4-infected participants with compensated cirrhosis is to assess the safety and to compare the percentage of participants achieving a 12-week sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment], to a clinically relevant threshold [based on SVR rates for HCV genotype 4-infected participants treated with pegylated interferon (pegIFN)/RBV].

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Ribavirin; Ritonavir

Criteria

Inclusion Criteria:

For Arms A, B and C:

• Participants must meet one of the following:

• Treatment-naive: Participant has never received antiviral treatment for hepatitis C infection OR

• Treatment Experienced (Prior null responders, Partial responders or Relapsers to IFN/RBV);

For Arm D:

• Participant must have prior treatment experience with SOF/pegIFN/RBV or SOF/RBV and meet one of the following categories:

• Prior SOF breakthrough/non-responder: HCV RNA detectable at the end of treatment with SOF/pegIFN/RBV or SOF/RBV;

• Prior SOF relapser: achieved HCV RNA undetectable at end of a prior treatment course SOF/pegIFN/RBV or SOF/RBV, but HCV RNA was detectable within 52 weeks following completion of therapy.

For Arms A, B, C and D:

• Chronic HCV genotype 4 infection with cirrhosis.

• Participant has plasma HCV RNA level > 1,000 IU/mL at Screening

Exclusion Criteria:

• Positive test result at Screening for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).

• Current enrollment in another interventional clinical study, previous enrollment in this study, or previous use of any protease inhibitor, non-nucleoside polymerase inhibitor, or Nonstructural viral protein (NS) 5A inhibitor, either investigational or commercially available (including previous exposure to paritaprevir or ombitasvir), or receipt of any investigational product within 6 weeks prior to study drug administration. Prior use of any direct-acting antiviral will not be allowed, except for Arm D where prior experience with the nucleoside polymerase inhibitor, sofosbuvir with pegIFN/RBV or SOF with RBV is required.

• Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites, variceal bleeding, or hepatic encephalopathy.

• Confirmed presence of hepatocellular carcinoma.

• Any cause of liver disease other than chronic HCV infection.

• Abnormal laboratory tests.