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To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection
Full description
determine the cure rate of Harvoni in treatment naïve alcoholic subjects with Genotype 1 HCV infection
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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:
Absence of cirrhosis is defined as any one of the following:
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:
Subject has not been treated with any investigational drug or device within 30 days of the screening visit.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
16 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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