Phase 2
Completed N=37
Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
Chronic Hepatitis C · Hepatitis C Virus (HCV) Infection
Source: ClinicalTrials.gov NCT01314261 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Percentage of Participants With 4-week Rapid Virologic Response (RVR) — 33.3; 55.6; 70.0; 22.2 percentage of participants — p=0.336
Summary
The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With 4-week Rapid Virologic Response (RVR) |
33.3; 55.6; 70.0; 22.2 | 0.336 |
| PRIMARY Maximum Plasma Concentration (Cmax) of ABT-267 |
10.7; 148; 535 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) of ABT-267 |
3.3; 3.8; 4.2 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267 |
115; 2200; 6130 | — |
| PRIMARY Plasma Concentrations of Ribavirin (RBV) |
1330; 1470; 1060; 1190; 1890; 1640 | — |
| PRIMARY Serum Concentrations of Pegylated Interferon (pegIFN) |
7.50; 6.12; 4.30; 4.83; 8.75; 9.22 | — |
| SECONDARY Percentage of Participants With Partial Early Virologic Response (pEVR) |
100.0; 88.9; 90.0; 77.8 | 0.102 |
| SECONDARY Percentage of Participants With Complete Early Virologic Response (cEVR) |
100.0; 88.9; 80.0; 66.7 | 0.083 |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing |
66.7; 66.7; 60.0; 33.3 | 0.155 |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing |
55.6; 44.4; 50.0; 22.2 | 0.127 |
| SECONDARY Median Time to Suppression of Hepatitis C Virus Ribonucleic Acid (HCV RNA) |
27.0; 16.0; 21.5; 84.0 | 0.007 sig |
| SECONDARY Percentage of Participants With Extended Rapid Virologic Response (eRVR) |
77.8; 77.8; 80.0; 22.2 | 0.028 sig |
Eligibility Criteria
Inclusion Criteria
- Treatment naïve participants
- Females must be either postmenopausal for at least 2 years or surgically sterile
- Males must be surgically sterile or practicing specific forms of birth control
- Chronic hepatitis C virus (HCV), genotype-1 infected participants
- Documented FibroTest score in combination with an Aspartate Aminotransferase to Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document absence of cirrhosis
Exclusion Criteria
- Pregnant or breastfeeding female
- Use of any medications contraindicated for use with pegylated interferon(pegIFN) or ribavirin (RBV) 2 weeks prior to study drug administration or 10 half-lives, whichever is longer
- Clinically significant cardiac, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness or psychiatric disease or disorder
- Current or past clinical evidence of cirrhosis or bridging fibrosis
- Abnormal screening laboratory results
Data sourced from ClinicalTrials.gov (NCT01314261). 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.