Phase 3
N=152
Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT02032901 ↗Enrolled (actual)
152
Serious AEs
0.7%
Results posted
Sep 2015
Primary outcome: Primary: Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) — 90.1 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Daclatasvir (Drug); Sofosbuvir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) |
90.1 | — |
| PRIMARY Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) |
86.3 | — |
| SECONDARY Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND) |
63.4; 72.5 | — |
| SECONDARY Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND) |
98.0; 100.0 | — |
| SECONDARY Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND) |
99.0; 100.0 | — |
| SECONDARY Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) |
11.9; 2.0; 34.7; 29.4; 86.1; 90.2 | — |
| SECONDARY Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND) |
39.6; 23.5; 77.2; 68.6; 94.1; 98.0 | — |
| SECONDARY Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) |
57.9; 69.2; 97.3; 94.1 | — |
| SECONDARY Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12) |
90.0; 95.0; 90.2; 80.6 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) |
1; 0; 0; 0 | — |
Summary
To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Key Inclusion Criteria
- Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
- Subjects chronically infected with hepatitis C virus (HCV) genotype 3
- Subjects who are HCV treatment-naive
- Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited)
- HCV RNA ≥10,000 IU/mL at screening
Key Exclusion Criteria
- HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted
- Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
- 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 screening
- Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
- Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Data sourced from ClinicalTrials.gov (NCT02032901). 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.