Phase 2
Completed N=28
Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)
Source: ClinicalTrials.gov NCT02175966 ↗Enrolled (actual)
28
Serious AEs
3.6%
Results posted
May 2019
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 (SVR12) — 28.6; 57.1 Percentage of participants
Summary
The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 (SVR12) |
28.6; 57.1 | — |
| PRIMARY Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Selected Grade 3/4 Laboratory Abnormalities |
0; 0 | — |
| SECONDARY Percentage of Participants With End of Treatment Response (EOTR) |
92.9; 100.0 | — |
| SECONDARY Percentage of Participants Who Achieved HCV RNA <LLOQ TD/TND |
35.7; 71.4; 78.6; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants Who Achieved HCV RNA < LLOQ TND |
21.4; 7.1; 42.9; 64.3; 92.9; 100.0 | — |
| SECONDARY Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b |
27.3; 54.5; 33.3; 66.7 | — |
| SECONDARY Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype) |
40.0; 66.7; 22.2; 50.0 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria
- Males and Females ≥18 years of age, inclusive
- Chronic HCV infection Genotype 1 only
- Non-cirrhotic
- Treatment naive subjects with no previous exposure to an Interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV) or HCV Direct Acting Antiviral (DAA) (protease, polymerase inhibitor, etc.)
Exclusion Criteria
- HCV Genotype other than Genotype 1
- Documented or suspected hepatocellular carcinoma
- Evidence of decompensated liver disease
- Contraindication(s) to Peg/RBV therapy
Data sourced from ClinicalTrials.gov (NCT02175966). 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.