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

Sponsor

University of Nebraska (Other)

Overall Status

Unknown status

CT.gov ID

NCT02759861

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection

Condition or Disease	Intervention/Treatment	Phase
Genotype 1 Hepatitis C Virus	Drug: harvoni	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase IV, Single Arm, Open-Label Study to Determine the Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF) in Treatment-Naive Alcoholic Subjects With Chronic Genotype 1 Hepatitis C Infection

Actual Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Harvoni x 8 or 12 weeks patient will receive 8 or 12 weeks depending on clinical data	Drug: harvoni 8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy Other Names: Ledipasvir/Sofosbuvir

Arm

Intervention/Treatment

Experimental: Harvoni x 8 or 12 weeks

patient will receive 8 or 12 weeks depending on clinical data

Drug: harvoni

8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy

Other Names:

Ledipasvir/Sofosbuvir

Outcome Measures

Primary Outcome Measures

The number of subjects who achieve negative RNA in alcoholics [12 weeks after the end of Harvoni therapy]
determined by blood draw

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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