Phase 3
Completed N=78
A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection
Source: ClinicalTrials.gov NCT02673489 ↗Enrolled (actual)
78
Serious AEs
10.3%
Results posted
Mar 2018
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR12) — 92.6; 75.0 Percentage of participants
◆ Published Evidence
Emerging
14citations · ~2 / year
Daclatasvir and sofosbuvir with ribavirin for 24 weeks in chronic hepatitis C genotype-3-infected patients with cirrhosis: a Phase III study (ALLY-3C).
Summary
The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients with liver cirrhosis.
Linked Publications
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Daclatasvir and sofosbuvir with ribavirin for 24 weeks in chronic hepatitis C genotype-3-infected patients with cirrhosis: a Phase III study (ALLY-3C).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR12) |
92.6; 75.0 | — |
| SECONDARY Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms |
85.7; 0.0; 93.6; 78.3 | — |
| SECONDARY Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24 |
14.8; 12.5; 50.0; 54.2; 92.6; 75.0 | — |
| SECONDARY Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24 |
1.9; 0.0; 11.1; 12.5; 64.8; 62.5 | — |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Genotype 3 HCV
- HCV RNA ≥10000 IU (International Unit)/mL
- Compensated Liver Cirrhosis
- BMI 18-40 kg/m2
- Previously treated for HCV or never treated for HCV
Exclusion Criteria
- Infection with HCV other than Genotype 3. Mixed infection of any genotype
- Evidence of decompensated liver disease
- Previous exposure to NS5A inhibitors
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT02673489) 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.