Phase 2
Completed N=70
A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
Source: ClinicalTrials.gov NCT02292719 ↗Enrolled (actual)
70
Serious AEs
4.3%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 100; 90.9; 90.0; 44.4 percentage of participants
Summary
The purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV infection with or without Cirrhosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
100; 90.9; 90.0; 44.4; 100; 100 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
0; 0; 10.0; 55.6; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic HCV infection prior to study enrollment.
- Screening laboratory results from the central clinical laboratory indicating HCV genotype 2 or 3 infection only (no mixed genotype).
- Absence OR presence of cirrhosis.
- If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (HCC)
Exclusion Criteria
- Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
- Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse.
- Current enrollment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV therapy (other than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir, boceprevir, ABT-450, or ombitasvir (ABT-267).
- Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.
- Abnormal lab tests.
- Females who are pregnant or plan to become pregnant or breastfeeding, or males whose partners are pregnant or planning to become pregnant
Data sourced from ClinicalTrials.gov (NCT02292719). 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.