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.
Name: Simeprevir 150 mg
Description: Simeprevir 150 mg capsule orally once daily.Type: DrugArm A Arm B
Name: Daclatasvir 60 mg
Description: Daclatasvir 60 mg tablet orally once daily.Type: DrugArm A Arm B
Name: Sofosbuvir 400 mg
Description: Sofosbuvir 400 mg tablet orally once daily.Type: DrugArm A Arm B
Description: Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment.
Measure: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After End of Study Drug Treatment (SVR12) Time: 12 weeks after end of study drug treatment (week 18 for Arm A and week 20 for Arm B)Description: On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold.
The following thresholds were considered at any time point:
Description: Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was
Description: Participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. Includes participants with: 1) viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA 2) confirmed detectable HCV RNA at the actual end of treatment (example, completed treatment, discontinued due to adverse events, withdrawal of consent) of >100 IU/mL in participants whose HCV RNA had previously been
Description: Viral Relapse: Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during followup.
Measure: Number of Participants With Viral Relapse Time: From Week 6 to Week 18 (for Arm A) and From Week 8 to Week 20 (for Arm B)Description: Late Viral Relapse: Participant who achieved SVR12 and the post treatment HCV RNA measurement fulfilled 1 the following conditions: a) at least 2 consecutive measurements not lesser than (<)15 IU/mL undetectable, of which at least the second measurement was >=15 IU/mL quantifiable or b) the last available measurement was >=15 IU/mL quantifiable.
Measure: Number of Participants With Late Viral Relapse Time: From Week 18 to Week 30 (for Arm A), From Week 20 to Week 32 (for Arm B)Description: 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.
Measure: Number of Participants With HCV Nonstructural Protein 3/4A (NS3/4A), NS5A and NS5B Sequence in Participants Not Achieving SVR Time: Up to Week 30 for Arm A and up to Week 32 for Arm BDescription: The Q80K polymorphism, associated with low level SMV in vitro resistance. Percentage of participants who achieved SVR with or without an NS3 Q80K polymorphism at baseline were reported.
Measure: Percentage of Participants With or Without an NS3 Q80K Polymorphism at Baseline Achieving SVR Time: up to Week 30 for Arm A and Week 32 for Arm BAllocation: Non-Randomized
Parallel Assignment
There is one SNP
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 ---