Phase 2
Completed N=68
Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
Source: ClinicalTrials.gov NCT02349048 ↗Enrolled (actual)
68
Serious AEs
1.5%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After End of Study Drug Treatment (SVR12) — 86.4; 100 Percentage of Participants
Summary
The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not having received treatment with any approved or investigational drug) participants with chronic hepatitis (inflammation of the liver) C virus (HCV) genotype 1 infection with early stages of liver fibrosis or with cirrhosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After End of Study Drug Treatment (SVR12) |
86.4; 100 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Response |
96.4; 100; 7.1; 0; 3.6; 0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at 4 Weeks (SVR4) and 24 Weeks (SVR24) After End of Study Drug Treatment |
93.2; 100; 84.7; 100 | — |
| SECONDARY Percentage of Participants With On-Treatment Failure |
1.7; 0 | — |
| SECONDARY Number of Participants With Viral Relapse |
7; 0 | — |
| SECONDARY Number of Participants With Late Viral Relapse |
1; 0 | — |
| SECONDARY Number of Participants With HCV Nonstructural Protein 3/4A (NS3/4A), NS5A and NS5B Sequence in Participants Not Achieving SVR |
8; 0 | — |
| SECONDARY Percentage of Participants With or Without an NS3 Q80K Polymorphism at Baseline Achieving SVR |
88.0; 100; 78.3; 100 | — |
Eligibility Criteria
Inclusion Criteria
- HCV genotype 1 infection and HCV RNA plasma level greater than (>) 10,000 international units per milliliter (IU/mL), both determined at Screening
- Participants of Arm A should have evidence of early stages of liver fibrosis, defined by a FibroSURE score less than or equal to ( 0.75 and APRI score >2, OR a previous (historical) biopsy documenting a METAVIR score F4. In addition, participants should have absence of esophageal varices or presence of small (grade 1) esophageal varices determined by upper gastrointestinal endoscopy, and absence of findings indicative of hepatocellular carcinoma in an ultrasonography
- HCV treatment-naive, defined as not having received treatment with any approved or investigational drug for chronic HCV infection
- Pegylated interferon (PegIFN) and ribavirin (RBV) eligible, defined as not having any contraindication to the use of PegIFN and RBV, in line with the prescribing information for each compound
Exclusion Criteria
A. Main Study:
- Co-infection with HCV of another genotype than genotype 1 and/or human immunodeficiency virus (HIV) type 1 or 2 (positive HIV-1 or HIV 2 antibody test at Screening)
- Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A infection, hepatitis B infection (hepatitis B surface antigen positive), drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the Investigator
- Evidence of clinical hepatic decompensation or presence of grade 2/3 esophageal varices
- Any of the protocol defined laboratory abnormalities
B. Sub-study:
- Presence of coagulopathy (hemophilia) or hemoglobinopathy (including sickle cell disease, thalassemia)
- Use of any anti-coagulant (for example, warfarin, heparin) or anti-platelet medications within 1 week of the Screening visit
- Any of the protocol defined laboratory abnormalities
Data sourced from ClinicalTrials.gov (NCT02349048). 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.