Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics

determine the cure rate of Harvoni in treatment naïve alcoholic subjects with Genotype 1 HCV infection

Inclusion criteria

• The subject must be willingly and able to provide written informed consent
• Age 19 years of age or older (The age of consent in Nebraska)
• HCV treatment-naïve, as defined as no prior exposure to any Interferon (IFN), RBV, or other FDA approved or experimental HCV-specific direct-acting antiviral agent
• HCV RNA level at most 6 months prior to the Baseline/Day 1 visit.
• HCV genotyping 1a, 1b, or mixed 1a/ab. Any non-definitive results will exclude the subject from study participation.
• Alcohol misuse as defined by the Alcohol Use Disorders Identification Test (AUDIT) score subjects must score > 8 (associated with harmful or hazardous drinking)
• Cirrhosis determination [up to 20% of study subjects may have cirrhosis]:

• Cirrhosis is defined as any one of the following:

• History of a liver biopsy showing cirrhosis (e.g. Metavir score = 4 or Ishak score > 5)
• Fibroscan showing cirrhosis or results > 12.5 kPa
• FIBRO Spect II index consistent with F3 or F4 AND an AST : platelet ration index (APRI) of > 2 during Screening
• Absence of cirrhosis is defined as any one of the following:

• Liver biopsy within 2 years of Screening showing absence of cirrhosis
• Fibroscan within 6 months of Baseline/Day1 with a result of ≤ 12.5 kPa
• FIBRO Spect II Index consistent with F0- F2 AND APRI of ≤ 1 during Screening
• Liver imaging within 6 months of Baseline/Day 1 to exclude hepatocellular carcinoma HCC) is required
• Subjects must have the following laboratory parameters at screening:

• ALT < 10 x the upper limit of normal (ULN)
• AST < 10 x ULN
• Direct bilirubin < 2.0 x ULN
• Platelets > 50,000
• HbA1c < 8.5%
• Creatinine clearance (CLcr) ≥ 60 mL /min, as calculated by the Cockcroft-Gault equation
• Hemoglobin ≥ 11 g/dL for female subjects; ≥ 12 g/dL for male subjects.
• Albumin ≥ 2.5 g/dL
• INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.
• Subject has not been treated with any investigational drug or device within 30 days of the screening visit.

Exclusion criteria

• Pregnant women and nursing mothers are ineligible due to the possible risk of adverse effects in the newborn. Eligible patients of reproductive potential should use adequate contraception if sexually active.
• Serious concurrent medical illness which would jeopardize the ability of the subject to receive the therapy as outlined in this protocol with reasonable safety.
• Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for a malignancy are not eligible.
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Use of any prohibited concomitant medications within 30 days of the Baseline/Day 1 visit.
• Known hypersensitivity to LDV/SOF