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

Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the actual end of treatment.

Time frame: Week 24

Population: Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.

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).

Time frame: Baseline, Follow-up Week 12 and 24

Population: Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.

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.

Time frame: Baseline, Week 12, Follow-up Week 12 and 24

Population: Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.

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.

Time frame: Baseline, Week 4, Week 12 and Follow-Up Week 12

Population: Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.

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.

Time frame: Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24

Population: Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.

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.

Time frame: Week 36

Population: Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.

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.

Time frame: Week 16

Population: Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.

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.

Time frame: Baseline, Week 12, Follow-up Week 12 and 24

Population: Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.

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.

Time frame: Week 12

Population: Intent-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.

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.

Time frame: Week 2, 4 and End of Treatment (Week 12)

Population: Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point.

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).

Time frame: Up to End of Treatment (Week 12)

Population: Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.

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.

Time frame: During the Follow-up (Week 24)

Population: Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.