Phase 3
Completed N=103
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis
Source: ClinicalTrials.gov NCT02114151 ↗Enrolled (actual)
103
Serious AEs
4.9%
Results posted
Apr 2016
Primary outcomePrimary: Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT) — 83.5 Percentage of Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or treatment-experienced.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT) |
83.5 | — |
| SECONDARY Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT) |
86.4 | — |
| SECONDARY Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT) |
82.5 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Response |
90.2; 68.6; 44.1; 24.5; 99.0; 99.0 | — |
| SECONDARY Percentage of Participants With On-treatment Failure |
2.9 | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
1.9 | — |
| SECONDARY Percentage of Participants With Viral Relapse |
13.1 | — |
| 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 |
17.4; -4.9; -4.7; -5.8 | — |
| SECONDARY Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24 |
3.4; -0.4; -0.6; -0.8 | — |
| SECONDARY Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D) |
67.7; 16.7; 15.6; 77.3; 15.9; 6.8 | — |
| SECONDARY Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24 |
70.1; 9.8; 9.5 | — |
| 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 |
13; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02114151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.