Phase 3
Completed N=148
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults
Chronic Hepatitis C Infection
Source: ClinicalTrials.gov NCT01854528 ↗
Enrolled (actual)
148
Serious AEs
4.1%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment — 100.0; 66.0 percentage of participants — p=<0.001
Summary
The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267; ABT-267 also known as ombitasvir] and ABT-333 [also known as dasabuvir]) plus ribavirin (RBV) compared with telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment |
100.0; 66.0 | <0.001 sig |
| SECONDARY Mean Change From Baseline to Final Treatment Visit in the Mental Component Summary (MCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2) |
-1.3; -9.8 | <0.001 sig |
| SECONDARY Mean Change From Baseline to Final Treatment Visit in the Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2) |
0.4; -7.7 | <0.001 sig |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment |
99.0; 66.0 | <0.001 sig |
| SECONDARY Percentage of Participants With Virologic Failure During Treatment |
0; 19.1 | — |
| SECONDARY Percentage of Participants With Virologic Relapse After Treatment |
0; 6.3 | — |
Eligibility Criteria
Inclusion Criteria
- Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
- Chronic hepatitis C infection (positive for anti-HCV antibody or HCV RNA at least 6 months before screening and at the time of screening; or positive for anti-HCV antibody or HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection)
- Screening laboratory result indicating HCV genotype 1 infection (HCV GT1)
- Participant must have documentation of adherence to a prior pegIFN/RBV combination therapy and meet one of the protocol definitions for treatment failure: null responder, partial responder, relapser
- No evidence of liver cirrhosis
Exclusion Criteria
- Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
- Positive screen for drugs or alcohol
- Significant sensitivity to any drug
- Use of contraindicated medications within 2 weeks of dosing
- Abnormal laboratory tests
Data sourced from ClinicalTrials.gov (NCT01854528). 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.