Phase 2
N=168
Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus
Hepatitis C Virus
Bottom Line
View on ClinicalTrials.gov: NCT01628692 ↗Enrolled (actual)
168
Serious AEs
6.6%
Results posted
Nov 2015
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12) — 84.9; 69.6; 74.5; 95 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Daclatasvir (Drug); Simeprevir (Drug); Ribavirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12) |
84.9; 69.6; 74.5; 95; 66.7; 0 | — |
| SECONDARY Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 |
79.2; 69.6; 68.6; 85; 75; 33.3 | — |
| SECONDARY Percentage of Participants With Complete Early Virologic Response (cEVR) |
84.9; 73.9; 82.4; 90; 66.7; 11.1 | — |
| SECONDARY Percentage of Participants With Extended Rapid Virologic Response (eRVR) |
71.7; 60.9; 62.7; 75; 58.3; 11.1 | — |
| SECONDARY Percentage of Participants With End of Treatment Response (EOTR) |
88.7; 78.3; 78.4; 95; 66.7; 0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories |
87.5; 100; 84.6; 100; 66.7; NA | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died |
7; 3; 1; 2; 2; 0 | — |
Summary
The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.
Eligibility Criteria
Key Inclusion Criteria
- Hepatitis C virus (HCV) genotype 1a or 1b
- Males and females, ≥18 years of age
- HCV RNA ≥10,000 IU/mL
- Participants with compensated cirrhosis are permitted
- Advanced fibrosis (F3/F4) is capped at approximately 35% of the total treated population with a minimum of 20% F4 patients
- If no cirrhosis, a liver biopsy within 3 years prior to enrollment
- If cirrhosis is present, any prior liver biopsy
Key Exclusion Criteria
- Liver or any other transplant (other than cornea and hair)
- Evidence of a medical condition contributing to chronic liver disease other than HCV infection
- Current or known history of cancer, (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
- Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
- Patients infected with HIV or hepatitis B virus
- Gastrointestinal disease impacting absorption of study drug
- Uncontrolled diabetes or hypertension
- Prior exposure to an HCV direct-acting agent
- Any criteria that would exclude the patient from receiving ribavirin
- Absolute neutrophil count 500 mSec
- Creatinine clearance ≤50 mL/min
- Alpha fetoprotein (AFP) >100 ng/mL OR
- AFP ≥50 ng/mL and ≤100 ng/mL requiring liver ultrasound
- Albumin <3.5 g/dL
Data sourced from ClinicalTrials.gov (NCT01628692). 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.