Phase 3
Completed N=310
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis
Source: ClinicalTrials.gov NCT02114177 ↗Enrolled (actual)
310
Serious AEs
1.6%
Results posted
Apr 2016
Primary outcomePrimary: Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12) — 82.6; 96.8 Percentage of participants
◆ Published Evidence
Highly cited
189citations · ~19 / year
Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study.
Summary
The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or treatment-experienced.
Linked Publications
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Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12) |
82.6; 96.8 | — |
| SECONDARY Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4) |
83.9; 96.8 | — |
| SECONDARY Percentage of Participants Achieving a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24) |
82.6; 96.8 | — |
| SECONDARY Percentage of Participants Achieving a On-treatment Virologic Response |
90.9; 93.4; 77.92; 79.6; 40.26; 45.4 | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
0; 0 | — |
| SECONDARY Percentage of Participants With Viral Relapse |
17.4; 2.6 | — |
| SECONDARY Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS) |
10.8; 13.3; -0.4; -0.9; -0.2; -0.4 | — |
| SECONDARY Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24 |
2.9; 3.2; -0.1; -0.1; -0.1; -0.2 | — |
| SECONDARY Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores |
8.8; 10.2; -0.6; -0.8; -0.6; -0.3 | — |
| SECONDARY Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale |
79.3; 76.7; 4.6; 2.4; 4.0; 2.7 | — |
Eligibility Criteria
Inclusion Criteria
- Hepatitis C virus (HCV) genotype 1a or 1b infection confirmed before randomization
- Documentation of the presence or absence of a NS3 Q80K polymorphism in HCV genotype 1a infected participants before randomization
- Documentation of the IL28B genotype before randomization
- HCV ribonucleic acid level 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
- Absence of cirrhosis in participants
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 1a or 1b
- 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 (NCT02114177) and the linked publication. 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.