Genotype 1 Hepatitis C Virus
Conditions
Brief summary
To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection
Detailed description
determine the cure rate of Harvoni in treatment naïve alcoholic subjects with Genotype 1 HCV infection
Interventions
DRUGharvoni
8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy
Sponsors
University of Nebraska
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject must be willingly and able to provide written informed consent 2. Age 19 years of age or older (The age of consent in Nebraska) 3. 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 4. HCV RNA level at most 6 months prior to the Baseline/Day 1 visit. 5. HCV genotyping 1a, 1b, or mixed 1a/ab. Any non-definitive results will exclude the subject from study participation. 6. Alcohol misuse as defined by the Alcohol Use Disorders Identification Test (AUDIT) score subjects must score \> 8 (associated with harmful or hazardous drinking) 7. Cirrhosis determination \[up to 20% of study subjects may have cirrhosis\]: 1. 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 2. 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 8. Liver imaging within 6 months of Baseline/Day 1 to exclude hepatocellular carcinoma HCC) is required 9. Subjects must have the following laboratory parameters at screening: 1. ALT \< 10 x the upper limit of normal (ULN) 2. AST \< 10 x ULN 3. Direct bilirubin \< 2.0 x ULN 4. Platelets \> 50,000 5. HbA1c \< 8.5% 6. Creatinine clearance (CLcr) ≥ 60 mL /min, as calculated by the Cockcroft-Gault equation 7. Hemoglobin ≥ 11 g/dL for female subjects; ≥ 12 g/dL for male subjects. 8. Albumin ≥ 2.5 g/dL 9. INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR. 10. Subject has not been treated with any investigational drug or device within 30 days of the screening visit.
Exclusion criteria
1. 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. 2. Serious concurrent medical illness which would jeopardize the ability of the subject to receive the therapy as outlined in this protocol with reasonable safety. 3. 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. 4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) 5. Use of any prohibited concomitant medications within 30 days of the Baseline/Day 1 visit. 6. Known hypersensitivity to LDV/SOF
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Subjects Who Achieve Negative RNA in Alcoholics | 12 weeks after the end of Harvoni therapy | Sustained viral response in treatment -naive heavy alcohol drinking patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR | 12 weeks after the end of Harvoni therapy | Number of alcoholics with HCV type 1 genotype who had advanced fibrosis F3/F4 who achieve SVR |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Harvoni x 8 or 12 Weeks patient will receive 8 or 12 weeks depending on clinical data
harvoni: 8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Harvoni x 8 or 12 Weeks |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Race/Ethnicity, Customized Black | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 14 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 16 |
| other Total, other adverse events | 13 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
The Number of Subjects Who Achieve Negative RNA in Alcoholics
Sustained viral response in treatment -naive heavy alcohol drinking patients.
Time frame: 12 weeks after the end of Harvoni therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Harvoni x 8 or 12 Weeks | The Number of Subjects Who Achieve Negative RNA in Alcoholics | 14 Participants |
Secondary
Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR
Number of alcoholics with HCV type 1 genotype who had advanced fibrosis F3/F4 who achieve SVR
Time frame: 12 weeks after the end of Harvoni therapy
Population: Had fibrosis F3/F4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Harvoni x 8 or 12 Weeks | Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR | 8 Participants |