Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, With Non-severe Fibrosis

Inclusion Criteria

• Willing and able to provide written informed consent
• Male or female, age ≥ 18 years
• Body Mass Index (BMI) ≥ 18 kg/m2
• HCV RNA ≥ 100 000 IU/mL at Screening
• Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy, only genotype 1b virus. (Positive for anti HCV antibody, HCV RNA, or an HCV genotype)
• Treatment-naïve with no prior exposure to any IFN, RBV, or approved or experimental HCV-specific DAA
• Non severe fibrosis (F 10 x the upper limit of normal (ULN)
• AST > 10 x ULN
• Direct bilirubin > 1.5 x ULN
• Platelets 8.5%
• Creatinine clearance 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regime affecting INR
• Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Clinically-relevant alcohol or drug abuse within 12 months of Screening.
• Alcohol, intravenous drugs, inhalational (not including marijuana), psychotropic, narcotics, cocaine use, prescription or over-the-counter drugs: within 1 year of the screening visit, or if shorter, is judged by investigator to be capable of complying with study procedures
• receiving opiate agonist substitution therapy within 1 year of screening visit, or if shorter, is judged by investigator to be capable of complying with study procedures
• history of marijuana use if deemed excessive by a physician investigator or interferes with the subject's daily function. If subject's marijuana use is not deemed excessive and does not interfere with daily function, subject must agree to discontinue any current use of recreational marijuana prior to entry into trial and throughout the trial period
• A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator
• Use of any prohibited concomitant medication listed in Section 5.5 of this protocol within 2 weeks prior to day 1.
• Known hypersensitivity to the study drug, the metabolites, or formulation excipient
• is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study. Collection of additional blood, urine, or tissue samples or additional data, beyond that specified in this protocol, is prohibited (other than that related to subject's medical care).
• (female) is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential and unwilling to commit to two methods of birth control throughout treatment and after the completion of all treatment (see Inclusion Criteria); or male subject is planning to impregnate or provide sperm donation or has a female sexual partner of childbearing potential and is unwilling to commit to using a two methods of birth control throughout treatment and after the completion of all treatment (see Inclusion Criteria).
• had a life-threatening SAE during the screening period. 2. is a member or a family member of the investigational study staff or sponsor staff directly involved with this study.
• has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis.
• NOTE: Subjects with history of acute non-HCV-related hepatitis, which resolved > 6 months before study entry, may be enrolled.
• For subjects diagnosed with diabetes mellitus, documented HbA1c >8.5% (to exclude uncontrolled diabetes).
• Has any of the following conditions:.
• Subject with a history of gastric surgery (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., celiac sprue disease).
• Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during t