- 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
carcinoma. For those subjects with an ultrasound conducted outside the 6-month time
window, an ultrasound must be performed prior to randomization.
- Co-infection with either HIV or HBV.
- Evidence of severe or decompensated liver disease.
- Subjects with liver disease unrelated to HCV infection.
- Pre-existing medical condition that makes the subject unsuitable for treatment with
pegIFN/RBV therapy per product labeling.
- Laboratory abnormality at Screening that makes the subject unsuitable for treatment
with pegIFN/RBV therapy per product labeling.
- Abnormal ECG suggestive of clinically significant cardiac disease or QTc>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.