HCV Genotype 1 or 4 who previously failed treatment with Peginterferon alfa-2a or peginterferon alfa-2b and Ribavirin (P/R), classified as previous null and partial responders based on previous therapy
HCV RNA ≥ 10,000 IU/mL
Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)
You may not be if
Prior treatment of HCV with HCV direct acting antiviral (DAA)
Evidence of a medical condition contributing to chronic liver disease other than HCV
Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Diagnosed or suspected hepatocellular carcinoma or other malignancies
Uncontrolled diabetes or hypertension
Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease
Alanine aminotransferase (ALT) ≥ 5x Upper limit of normal (ULN)
Albumin \< 3.5 g/dL (35 g/L)
Alpha Fetoprotein (AFP) \> 100 ng/mL (\>82.6 IU/mL) or ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of Hepatocellular carcinoma (HCC) are excluded
Absolute neutrophil count (ANC) \< 1.5 x 1000,000,000 cells/L (\< 1.2 x 1000,000,000 cells/L for Black/African-Americans)
Platelets \< 90 x 1000,000,000 cells/L
Hemoglobin \< 12 g/dL for females or \< 13 g/dL for males
Any criteria that would exclude the subject from receiving P/R
Clareo Health | Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)
