Efficacy and Safety of Daclatasvir Plus Asunaprevir in Chronic Hepatitis C

Study Overview
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Brief Summary
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We perform this study to identity efficacy and safety of Daclatasvir and Asunaprevir in real practice.

Official Title
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Efficacy and Safety of Daclatasvir Plus Asunaprevir Treatment in Patients With Chronic Hepatitis C : Prospective Cohort Study

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: Daclinza and Sunvepra


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide written informed consent Males and females, ≥ 18 years of age HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive HCV RNA ≥ 10,000 IU/mL Subjects with compensated cirrhosis are permitted Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg) Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all fertile males with partners of childbearing age and all females with childbearing potential must use reliable contraception method during the study and for 3 months after treatment completion. Exclusion Criteria: Inability or unwillingness to provide informed consent or abide by the requirements of the study Other than genotype 1 infection Prior treatment of HCV with HCV direct acting antiviral agents (DAA) Patient who has any history of major organ transplantation with an existing functional graft or Patient who has plan to receive organ transplant Diagnosed or suspected hepatocellular carcinoma or other malignancies Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy Evidence of a medical condition contributing to chronic liver disease other than HCV Uncontrolled diabetes or hypertension Women with ongoing pregnancy or who are breast feeding Evidence of alcohol and/or drug abuse Patient who has NS5A resistance associated variant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Daclinza and Sunvepra | Drug: Daclinza and Sunvepra<br>* direct acting antiviral agent against to hepatitis C virus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Responase |  | week 12 (after treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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daclatasvir, asunaprevir