Phase 3
Completed N=184
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)
Source: ClinicalTrials.gov NCT02265237 ↗Enrolled (actual)
184
Serious AEs
6.0%
Results posted
Aug 2017
Primary outcomePrimary: Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 96.6; 100.0; 93.4 percentage of participants
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].
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
96.6; 100.0; 93.4 | — |
| SECONDARY Percentage of Participants With SVR12 in Participants Receiving 12 Weeks (Arm A) of Treatment Compared to Participants Receiving 16 Weeks of Treatment (Arm B) |
96.6; 100 | 0.304 |
| SECONDARY Percentage of Participants With SVR12 in Participants Receiving 16 Weeks (Arm B) of Treatment Compared to Participants Receiving 24 Weeks of Treatment (Arm C) |
100; 93.4 | 0.086 |
| SECONDARY Percentage of Participants in Arms A, B and C With On-treatment Virologic Failure |
1.7; 0; 0 | — |
| SECONDARY Percentage of Participants in Arms A, B and C With Post-treatment Relapse |
0; 0; 0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02265237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.