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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 147 participants from the United States and Canada were Screened and 103 were enrolled into the study. All 103 participants who received at least 1 dose of study drug and so were included in intent to treat (ITT) population.

Reporting Groups

	Description
Simeprevir Plus Sofosbuvir	Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.

Participant Flow:   Overall Study

	Simeprevir Plus Sofosbuvir
STARTED	103
COMPLETED	96
NOT COMPLETED	7
Death	1
Lost to Follow-up	1
Withdrawal by Subject	5

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Simeprevir Plus Sofosbuvir	Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.

Baseline Measures

	Simeprevir Plus Sofosbuvir
Overall Participants Analyzed  [Units: Participants]	103
Age  [Units: Years] Median (Full Range)	58   (29 to 69)
Gender  [Units: Participants]
Female	20
Male	83

1.  Primary:

Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT)   [ Time Frame: Week 24 ]

2.  Secondary:

Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)   [ Time Frame: Week 16 ]

3.  Secondary:

Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT)   [ Time Frame: Week 36 ]

4.  Secondary:

Percentage of Participants With On-treatment Virologic Response   [ Time Frame: Week 2, 4 and End of Treatment (Week 12) ]

5.  Secondary:

Percentage of Participants With On-treatment Failure   [ Time Frame: Week 12 ]

6.  Secondary:

Percentage of Participants With Viral Breakthrough   [ Time Frame: Up to End of Treatment (Week 12) ]

7.  Secondary:

Percentage of Participants With Viral Relapse   [ Time Frame: During the Follow-up (Week 24) ]

8.  Secondary:

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 ]

9.  Secondary:

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 ]

10.  Secondary:

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 ]

11.  Secondary:

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 ]

12.  Secondary:

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 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.