Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis

• Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT) [ Time Frame: Week 16 ]
  Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the actual end of treatment.
• Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT) [ Time Frame: Week 36 ]
  Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 24 weeks after the actual end of treatment.
• Percentage of Participants With On-treatment Virologic Response [ Time Frame: Week 2, 4 and End of Treatment (Week 12) ]
  On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. <LLOQ undetectable was considered as threshold at any time point. The LLOQ value is 25 IU/mL. EOT=End of Treatment.
• Percentage of Participants With On-treatment Failure [ Time Frame: Week 12 ]
  On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment.
• Percentage of Participants With Viral Breakthrough [ Time Frame: Up to End of Treatment (Week 12) ]
  Viral breakthrough was defined as confirmed greater than (>) 1 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA < LLOQ (25 IU/mL).
• Percentage of Participants With Viral Relapse [ Time Frame: During the Follow-up (Week 24) ]
  Viral relapse was defined as participants who did not achieve SVR12 and had HCV RNA < LLOQ (25 IU/mL) undetectable at EOT and had HCV RNA >= LLOQ (25 IU/mL) during the follow-up period.
• Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12 [ Time Frame: Baseline, Week 4, Week 12 and Follow-Up Week 12 ]
  The HCV-SIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively.
• Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24 [ Time Frame: Baseline, Week 12, Follow-up Week 12 and 24 ]
  The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7-point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue.
• Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline, Week 12, Follow-up Week 12 and 24 ]
  The CES-D Scale assessed how often during the past week participants experienced 20 symptoms commonly associated with major depression. The CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5 to 7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores >=23 indicate probable major depressive illness.
• Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24 [ Time Frame: Baseline, Follow-up Week 12 and 24 ]
  The EQ-5D questionnaire was a brief, generic health-related quality of life (HRQOL) assessment that could also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assessed HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health).
• Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24 [ Time Frame: Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24 ]
  Sequencing of the HCV nonstructural protein 3/4A (NS3/4A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. Sequencing data is available for 16 participants.

• Number of Participants Achieving a Sustained Virologic Response 4 Weeks After the Planned end of Treatment (SVR4) [ Time Frame: Week 16 ]
  SVR4 is defined as the number of participants with less than 25 IU/mL detectable or undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) 4 weeks after planned end of treatment.The end of treatment is at Week 12; therefore, the outcome will be measured at Week 16.
• Number of Participants Achieving a Sustained Virologic Response 24 Weeks After the Planned end of Treatment (SVR24) [ Time Frame: Week 36 ]
  SVR24 is defined as the number of participants with less than 25 IU/mL detectable or undetectable plasma HCV RNA 24 weeks after planned end of treatment. The end of treatment is at Week 12; therefore, the outcome will be measured at Week 36.
• Number of Participants Achieving a On-treatment Virologic Response [ Time Frame: Day 1, Day 3, Day 7, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36 ]
  On-treatment virologic response is defined as the change from baseline in log10 hepatitis C virus ribonucleic acid.
• Number of Participants with Viral Breakthrough [ Time Frame: Up to Week 40 ]
  Viral breakthrough is defined as the number of participants with greater than 1 log10 IU/mL increase in plasma HCV RNA level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been less than 25 IU/mL.
• Number of Participants with Viral Relapse [ Time Frame: Up to Week 40 ]
  Viral relapse is defined as the number of participants who did not achieve sustained virologic response, have less than 25 IU/mL undetectable plasma HCV RNA at end of treatment, and greater than or equal to 25 IU/mL plasma HCV RNA during the follow-up phase.
• Change from baseline in Hepatitis C Symptom and Impact Questionnaire (HCV-SIQ) scores [ Time Frame: Baseline (Day 1) to Week 36 ]
  HCV-SIQv4 is a self-administered questionnaire which contains 33 items classified as 3 categories of scores: sum of responses to 29 symptom items as a symptom severity score category, sum of response to 3 items as a time missed from work/school category, and 1 response to question regarding the impact of symptoms on daily activities as an impairment in daily activity score category. The total score is the sum of scores of these 3 categories. Higher HCV-SIQv4 scores indicate worse symptom severity, more time missed from work/school, and more impairment in daily activities.
• Change From Baseline in Fatigue Severity Scale (FSS) Scores [ Time Frame: Baseline (Day 1) to Week 36 ]
  The FSS is a self-administered questionnaire with 9 items developed to assess disabling fatigue. These 9 item responses are measured on a 7-point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items are averaged to produce a total score. A lower total score indicates less effect of fatigue on everyday life.
• Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores [ Time Frame: Baseline (Day 1) to Week 36 ]
  The CES-D scale assesses how often during the past week participants experienced 20 symptoms commonly associated with major depression. CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5-7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores greater than or equal to 23 indicate probable major depressive illness.
• Change From Baseline in EuroQol 5 Dimension (EQ-5D) Questionnaire Scores [ Time Frame: Baseline (Day 1) to Week 36 ]
  The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. EQ-5D scores include EQ-5D valuation index score which includes a weighted scoring of the 5 dimension scores with a possible range from 0 to 1, EQ-5D visual analog scale (VAS) is a 20 cm vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health), and EQ5D descriptive system scores consist of five scores reflecting each of the 5 EQ-5D health dimensions ranging from 0 [no limitation] to 4 [incapacity]).

• Drug: Simeprevir
  100 participants will receive 1 capsule of 150 mg orally once daily for 12 weeks.
• Drug: Sofosbuvir
  100 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks.

Inclusion Criteria:

• Hepatitis C virus (HCV) genotype 1 infection (confirmed at screening).
• HCV ribonucleic acid (RNA) 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
• Participants must have an hepatic imaging procedure (ultrasound, computerized tomography scan or magnetic resonance imaging scan) within 6 months prior to the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
• Participant must be willing and able to comply with the protocol requirements
• Participants with liver cirrhosis

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 1
• 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