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Report for Clinical Trial NCT01170962

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy

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 Hepatitis C Virus
MeSH:Hepatitis C Hepatitis
HPO:Hepatitis

5 Interventions

Name: BMS-790052

Description: Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Type: Drug
Group Labels: 2

Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin

Name: BMS-790052

Description: Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Type: Drug
Group Labels: 2

Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin

Name: Placebo

Description: Film coated tablet, Oral, 0mg, Once daily, 24 weeks
Type: Drug
Group Labels: 1

Arm 5: Placebo plus peginterferon alfa-2a and ribavirin

Name: peginterferon alfa-2a

Description: Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Type: Drug
Group Labels: 6

Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin Arm 5: Placebo plus peginterferon alfa-2a an Arm 5: Placebo plus peginterferon alfa-2a and ribavirin

Name: ribavirin

Description: Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Type: Drug
Group Labels: 5

Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin Arm 5: Placebo plus peginterferon alfa-2a and ribavirin


Primary Outcomes

Description: eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

Measure: Percentage of Participants With Extended Rapid Virologic Response (eRVR)

Time: Week 4, Week 12

Description: SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA Measure: Percentage of Participants With 24-week Sustained Virologic Response (SVR24)

Time: Follow-up Week 24

Description: AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.

Measure: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment

Time: From first dose to last dose plus 7 days, up to 49 weeks

Description: AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.

Measure: Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period

Time: From day 8 post last dose of treatment up-to Week 72

Secondary Outcomes

Description: RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA Measure: Percentage of Participants With Rapid Virologic Response (RVR)

Time: Week 4

Description: cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA Measure: Percentage of Participants With Complete Early Virologic Response (cEVR)

Time: Week 12

Description: SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA Measure: Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)

Time: Follow-up Week 12

Description: Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.

Measure: Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures

Time: Baseline to follow-up Week 48

Description: 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.

Measure: Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures

Time: Baseline to follow-up Week 48

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 14 SNPs

SNPs


1 A92T

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 --- --- Q62E --- --- A92T ---


2 E62D

Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.. Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures. --- M28L --- --- Q30H --- --- L31M --- --- H54Y --- --- H58C --- --- E62D ---


3 H54Y

Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.. Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures. --- M28L --- --- Q30H --- --- L31M --- --- H54Y ---


4 H58C

Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.. Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures. --- M28L --- --- Q30H --- --- L31M --- --- H54Y --- --- H58C ---


5 L28M

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 ---


6 L31M

Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.. Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures. --- M28L --- --- Q30H --- --- L31M ---

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 ---


7 M28L

Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.. Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures. --- M28L ---


8 P58A

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 ---


9 Q30H

Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.. Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures. --- M28L --- --- Q30H ---


10 Q54H

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 ---


11 Q62E

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 --- --- Q62E ---


12 R30H

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 ---


13 Y93C

Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.. Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures. --- M28L --- --- Q30H --- --- L31M --- --- H54Y --- --- H58C --- --- E62D --- --- Y93C ---


14 Y93F

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 --- --- Q62E --- --- A92T --- --- Y93F ---



HPO Nodes


HPO: