Phase 3
N=36
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis
Chronic Hepatitis C · Decompensated Cirrhosis · Hepatitis C Virus
Bottom Line
View on ClinicalTrials.gov: NCT02219477 ↗Enrolled (actual)
36
Serious AEs
33.3%
Results posted
Jul 2017
Primary outcome: Primary: Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2 — 100; 95.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ombitasvir/paritaprevir/ritonavir (Drug); dasabuvir (Drug); ribavirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2 |
100; 95.8 | — |
| SECONDARY Percentage of Participants With SVR12 in Group 3 |
66.7 | — |
| SECONDARY Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse˅12 |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests |
77.8; 77.3; 50.0; 66.7; 72.7; 100 | — |
| SECONDARY Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest |
0; 9.1; 50.0 | — |
| SECONDARY Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Chld-Pugh Score |
66.7; 54.5; 50.0 | — |
| SECONDARY Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score |
87.5; 61.9; 100 | — |
Summary
The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.
Eligibility Criteria
Inclusion Criteria
- HCV GT1- or GT4-infection defined as: positive for anti-HCV Ab, HCV RNA > 1,000 IU/mL and laboratory result indicating HCV GT1 or GT4 infection at Screening.
- Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (i.e., computed tomography [CT] scan or magnetic resonance imaging [MRI]).
- Child-Pugh Score of 7 - 9, inclusive, at time of Screening.
Exclusion Criteria
- Women who are pregnant or breastfeeding.
- Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab).
- Prior or current use of any other investigational or commercially available anti-HCV agents other than interferon/RBV and/or pegylated interferon (pegIFN)/RBV (including but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir).
- Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as CT scan or MRI within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI).
- Any current or past evidence of Child-Pugh C classification.
Data sourced from ClinicalTrials.gov (NCT02219477). 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.