Dose Ranging of GSK2336805 in Combination Therapy

Inclusion Criteria

• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Male or female aged 18 to 70 years of age, inclusive, at Screening.
• Genotype 1 or genotype 4 hepatitis C virus (HCV) infection as assessed by Versant HCV Genotype assay 2.0 (LiPA).
• Chronic HCV infection documented by at least 1 measurement of serum HCV RNA greater than or equal to 100,000 IU/mL measured during Screening by the COBAS High Pure/COBAS TaqMan HCV Test v2.0 and at least one of the following:
• A positive anti-HCV antibody, HCV RNA, or HCV genotype test at least 6 months prior to Baseline (Day 1) together with positive HCV RNA and anti-HCV antibody tests at the time of Screening; or
• A positive HCV RNA test and anti-HCV antibody test at the time of Screening together with either a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of chronic hepatitis C disease, such as the presence of fibrosis).
• Naïve to all HCV antiviral treatment(s), including, but not limited to, immunomodulatory and nucleoside/nucleotide treatments for chronic HCV infection.
• Agree to interleukin 28B (IL28B) genotyping.
• A subject, who, in the opinion of the investigator, is an appropriate candidate for pegylated interferon alpha-2a (PEG)/ribavirin (RIBA)/protease inhibitor combination therapy for genotype 1 subjects and PEG/RIBA combination therapy for genotype 4 subjects.
• Body mass index >18 kg/m2 but not exceeding 36 kg/m2.
• A liver biopsy obtained within 3 years (36 calendar months) prior to the Day 1 visit, with a fibrosis classification of noncirrhotic as judged by a local pathologist (defined as Knodell less than or equal to 3, Metavir less than or equal to 2, Ishak less than or equal to 4, or Batts and Ludwig less than or equal to 2). Both incomplete and transition to cirrhosis (e.g., Metavir score 3) are considered as cirrhosis. If no recent ( Grade 1 nonalcoholic steatohepatitis, and toxin exposures). Subjects with Gilbert's syndrome who otherwise meet all inclusion/exclusion criteria are eligible.
• History of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions consistent with decompensated liver disease
• Positive results on urine screen for drugs of abuse test at Screening (unless used as medical treatment, e.g., with a prescription)
• History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation program)
• Screening visit electrocardiogram corrected QT (QTc) interval value >450 ms and/or clinically significant electrocardiogram findings
• Personal or family history of Torsade de Pointes findings
• Pregnant or nursing
• Male with a female partner who is pregnant
• Abnormal hematological and biochemical parameters, including:
• Neutrophil count 10 mg/day and radiation) within 6 months of the baseline visit or expects that such treatment will be needed at any time during the study.
• Participated in a clinical study with an investigational drug, biologic, or device within 3 months prior to the first dose administration.
• History of a known allergy to antiviral medications, including telaprevir, pegylated interferon alpha-2a (PEG), ribavirin (RIBA), or any excipient in the investigational product or history of drug or other allergy that, in the opinion of the investigator, contradicts participation.
• Requires prohibited medications