The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.

NCT01170962

Conditions

1. Hepatitis C Virus

Interventions

1. Drug: BMS-790052
2. Drug: BMS-790052
3. Drug: Placebo
4. Drug: peginterferon alfa-2a
5. Drug: ribavirin

MeSH:Hepatitis C Hepatitis

HPO:Hepatitis

Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.. Inclusion Criteria: - Subjects chronically infected with HCV genotype 1 - Non-responder to prior therapy with peginterferon alfa and ribavirin - HCV RNA viral load of 100,00 IU/mL - Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population) - Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma - Body Mass Index (BMI) of 18 to 35 kg/m2 Exclusion Criteria: - Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening - Evidence of medical condition associated with chronic liver disease other than HCV - Evidence of decompensated cirrhosis based on radiologic criteria or biopsy Inclusion Criteria: - Subjects chronically infected with HCV genotype 1 - Non-responder to prior therapy with peginterferon alfa and ribavirin - HCV RNA viral load of 100,00 IU/mL - Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population) - Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma - Body Mass Index (BMI) of 18 to 35 kg/m2 Exclusion Criteria: - Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening - Evidence of medical condition associated with chronic liver disease other than HCV - Evidence of decompensated cirrhosis based on radiologic criteria or biopsy Hepatitis C Virus Hepatitis C Hepatitis null --- L28M --- --- R30H --- --- L31M --- --- Q54H --- --- P58A ---