Phase 3
Completed N=10
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults
Chronic Hepatitis C Virus (HCV Infection Genotype 1)
Source: ClinicalTrials.gov NCT02399345 ↗
Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Dec 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment — 80 percentage of participants
Summary
This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment |
80 | — |
| SECONDARY Percentage of Subjects With On-treatment Virologic Failure |
— | — |
| SECONDARY Percentage of Subjects With Post-treatment Relapse |
20 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female at least 18 years of age at time of screening
- Chronic Hepatitis C virus (HCV) infection prior to study enrollment
- Screening laboratory results from the central clinical laboratory indicating HCV genotype 1 infection only
- Absence of cirrhosis and advanced bridging fibrosis
Exclusion Criteria
- Positive test result for hepatitis B surface antigen (HbsAg) or human immunodeficiency virus (HIV) positive immunoassay
- Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject an unsuitable candidate for this study or treatment with Ribavirin (RBV) in the opinion of the investigator
- Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis or advanced bridging fibrosis, e.g., a Metavir score > 2 or an Ishak score > 3
- Use of medications contraindicated for ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir, or ribavirin (RBV; for those that receive RBV), within 2 weeks or 10 half-lives whichever is longer, prior to study drug administration
- Current enrolment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV agents
Data sourced from ClinicalTrials.gov (NCT02399345). 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.