Phase 2
Completed N=288
Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects
Source: ClinicalTrials.gov NCT00987337 ↗Enrolled (actual)
288
Serious AEs
9.0%
Results posted
Jan 2014
Primary outcomePrimary: Percentage of Participants With Sustained Viral Response (SVR) at Week 72 — 41.7; 39.6; 45.8 percentage of participants
Summary
The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Viral Response (SVR) at Week 72 |
41.7; 39.6; 45.8 | — |
| SECONDARY Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12, 24 and 48 |
58.3; 61.5; 28.1; 76.0; 78.1; 67.7 | — |
| SECONDARY Percentage of Participants With Sustained Viral Response at 12 Weeks Following Completion of Therapy (SVR12) |
42.7; 44.8; 45.8 | — |
| SECONDARY Percentage of Participants With Sustained Viral Response at 24 Weeks Following Completion of Therapy (SVR24) |
73.3; 66.0; 65.7 | — |
| SECONDARY Percentage of Participants With Breakthrough Viremia |
4.2; 4.2; 7.3 | — |
| SECONDARY Percentage of Participants With Relapsed Response |
35.9; 42.9; 25.4 | — |
| SECONDARY Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12 and 24 |
6.1; 6.0; 6.1; -4.0; -4.2; -3.0 | — |
| SECONDARY Number of Adverse Events (AEs) by Severity (All Causality) |
672; 731; 745; 154; 169; 179 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Drug (Any Therapy) |
85; 88; 91; 88; 92; 92 | — |
| SECONDARY Number of Participants Who Discontinued Study Due to Adverse Events (AEs) |
10; 9; 8 | — |
| SECONDARY Number of Participants With Dose Reduction or Temporary Discontinuation Due to Adverse Events (AEs) |
28; 22; 28 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities by Severity |
11; 16; 8; 37; 46; 43 | — |
| SECONDARY Plasma Concentration of Filibuvir, Pegylated Interferon and Ribavirin |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects at least 18 years of age.
- HCV seropositive.
- HCV RNA >10,000 IU/mL at screening.
- HCV Genotype 1. Subjects infected with a non-genotype 1 strain or mixed genotypes are not eligible.
- Treatment naïve (no prior treatment with IFN alfa +/ RBV regimens or investigational anti-HCV agents).
- Liver biopsy within two years (24 months) of Screening with non-cirrhotic fibrosis classification. For those subjects with liver biopsy outside of the time window or for those subjects with no history of liver biopsy, a biopsy must be performed prior to randomization.
- Ultrasound within 6 months of Screening for 1) those subjects with bridging fibrosis or 2) those subjects with AFP >50 and 450msec.
- History of organ transplant.
- Contraindicated medications being taken by the subject at the time of randomization that must be continued during the study period, including potent CYP3A4 inhibitors, sensitive CYP3A4 substrates, CYP3A4 substrates with narrow therapeutic range and CYP3A4 inducers.
- Active alcohol or substance abuse sufficient, in the Investigator's judgment, to prevent adherence to study medication and/or follow up.
- Pregnant or nursing females.
- Males whose female partner is pregnant.
Data sourced from ClinicalTrials.gov (NCT00987337). 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.