Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications

• Status: Completed
• Trial end date: 2015-07-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 & Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Asunaprevir; Ribavirin

Criteria

Inclusion Criteria:

• Men and women, ages ≥18 years of age

• Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylated Interferon alfa (pegIFNα) plus Ribavirin (RBV) treatment

• Subjects should have chronic hepatitis C (CHC) as documented by:

1. Positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and Anti-HCV antibody at the time of screening, or

2. Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of CHC disease, such as the presence of fibrosis)

• HCV genotype 1a, 1b or 4 only

• HCV RNA viral load of ≥10,000 IU/mL at screening

• Have one of the following:

1. Documented Fibrotest score of ≤0.72 and aspartate transferase (transminase) to platelet ratio index (APRI) ≤2; OR

2. Documented liver biopsy within 36 months preceding Day 1 showing absence of cirrhosis OR

3. Documented Fibroscan® ultrasound (where approved) within 12 months of screening showing absence of cirrhosis

• Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive

• Subjects with compensated Child-Pugh A cirrhosis as documented by history of cirrhosis with any prior liver biopsy or Fibroscan® ultrasound (where approved) within 12 months prior to screening

Exclusion Criteria:

• Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis,metabolic liver disease, alcoholic liver disease, toxin exposures)

• History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis

• Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment

• Documented or suspected hepatocellular carcinoma (HCC)

• Positive for hepatitis B surface antigen (HBsAg)

• Positive for Human Immunodeficiency Virus-1 (HIV-1) and/or Human Immunodeficiency Virus-2 (HIV-2) antibodies

• Alanine transferase (transminase) (ALT) >5x upper limit of normal (ULN)

• Total Bilirubin ≥2 mg/dL