1. Achieve sustained virologic response (SVR) in patients infected with HCV genotype 1, cirrhosis, and early clinical decompensation using 12 weeks of Olysio/Sovaldi/Ribavirin (or known as: Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin (RBV). 2. Hepatic improvement during and after Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) treatment using a new test of liver function, HepQuant-SHUNT.

NCT02455167

Conditions

1. Hepatitis C

Interventions

1. Drug: Simeprivir (SMV)
2. Drug: Sofosbuvir (SOF)
3. Drug: Ribavirin (RBV)

MeSH:Hepatiti Hepatitis A Hepatitis C Hepatitis

HPO:Hepatitis

Inclusion Criteria: 1. HCV genotype 1 infection (all subtypes and Q80K a type of mutation are allowed), and have been approved by a third party payer for the FDA-approved combination of sofosbuvir (SOF) plus ribavirin. --- Q80K ---

The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.

NCT01349465

Conditions

1. Hepatitis C

Interventions

1. Drug: No treatment

MeSH:Infection Hepatitis A Hepatitis C Hepatitis

HPO:Hepatitis

AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.. Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study. --- Q80K ---

AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.. Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study. --- Q80K ---

The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not having received treatment with any approved or investigational drug) participants with chronic hepatitis (inflammation of the liver) C virus (HCV) genotype 1 infection with early stages of liver fibrosis or with cirrhosis.

NCT02349048

Conditions

1. Hepatitis C Virus

Interventions

1. Drug: Simeprevir 150 mg
2. Drug: Daclatasvir 60 mg
3. Drug: Sofosbuvir 400 mg

MeSH:Infection Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic

HPO:Chronic active hepatitis Chronic hepatitis Hepatitis

Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify preexisting sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR.. Percentage of Participants With or Without an NS3 Q80K Polymorphism at Baseline Achieving SVR. --- Q80K ---

The Q80K polymorphism, associated with low level SMV in vitro resistance. --- Q80K ---

Percentage of participants who achieved SVR with or without an NS3 Q80K polymorphism at baseline were reported.. Inclusion Criteria: - HCV genotype 1 infection and HCV RNA plasma level greater than (>) 10,000 international units per milliliter (IU/mL), both determined at Screening - Participants of Arm A should have evidence of early stages of liver fibrosis, defined by a FibroSURE score less than or equal to (<=) 0.48 and aspartate aminotransferase to platelet ratio index (APRI) score <=1 - Participants of Arm B should have evidence of cirrhosis, defined by a FibroSURE score >0.75 and APRI score >2, OR a previous (historical) biopsy documenting a METAVIR score F4. --- Q80K ---

The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or treatment-experienced.

NCT02114177

Conditions

1. Hepatitis C Virus Infection

Interventions

1. Drug: Simeprevir
2. Drug: Simeprevir
3. Drug: Sofosbuvir
4. Drug: Sofosbuvir

MeSH:Infection Communicable Diseases Hepatitis A Virus Diseases Hepatitis C Hepatitis Liver Cirrhosis Fibrosis

HPO:Cirrhosis Hepatic fibrosis Hepatitis

Lower scores indicate worsening.. Inclusion Criteria: - Hepatitis C virus (HCV) genotype 1a or 1b infection confirmed before randomization - Documentation of the presence or absence of a NS3 Q80K polymorphism in HCV genotype 1a infected participants before randomization - Documentation of the IL28B genotype before randomization - HCV ribonucleic acid level greater than 10,000 IU/mL at screening - Treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin - Absence of cirrhosis in participants Exclusion Criteria: - Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy) - Infection/co-infection with HCV non-genotype 1a or 1b - Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening) - Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen positive) - Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection Inclusion Criteria: - Hepatitis C virus (HCV) genotype 1a or 1b infection confirmed before randomization - Documentation of the presence or absence of a NS3 Q80K polymorphism in HCV genotype 1a infected participants before randomization - Documentation of the IL28B genotype before randomization - HCV ribonucleic acid level greater than 10,000 IU/mL at screening - Treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin - Absence of cirrhosis in participants Exclusion Criteria: - Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy) - Infection/co-infection with HCV non-genotype 1a or 1b - Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening) - Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen positive) - Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection Hepatitis C Virus Infection Infection Communicable Diseases Hepatitis A Virus Diseases Hepatitis C Hepatitis Liver Cirrhosis Fibrosis This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), multicenter study. --- Q80K ---

Lower scores indicate worsening.. Inclusion Criteria: - Hepatitis C virus (HCV) genotype 1a or 1b infection confirmed before randomization - Documentation of the presence or absence of a NS3 Q80K polymorphism in HCV genotype 1a infected participants before randomization - Documentation of the IL28B genotype before randomization - HCV ribonucleic acid level greater than 10,000 IU/mL at screening - Treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin - Absence of cirrhosis in participants Exclusion Criteria: - Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy) - Infection/co-infection with HCV non-genotype 1a or 1b - Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening) - Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen positive) - Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection Inclusion Criteria: - Hepatitis C virus (HCV) genotype 1a or 1b infection confirmed before randomization - Documentation of the presence or absence of a NS3 Q80K polymorphism in HCV genotype 1a infected participants before randomization - Documentation of the IL28B genotype before randomization - HCV ribonucleic acid level greater than 10,000 IU/mL at screening - Treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin - Absence of cirrhosis in participants Exclusion Criteria: - Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy) - Infection/co-infection with HCV non-genotype 1a or 1b - Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening) - Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen positive) - Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection Hepatitis C Virus Infection Infection Communicable Diseases Hepatitis A Virus Diseases Hepatitis C Hepatitis Liver Cirrhosis Fibrosis This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), multicenter study. --- Q80K --- --- Q80K ---