Chronic HCV genotype 1b infection
Conditions
Interventions
24-week course of daclatasvir (Daklinza
Bristol-Myers Squibb, Tokyo, Japan) (60 mg tablet once daily) and asunaprevir (Sunvepra
Bristol-Myers) (100 mg softgel capsule twice daily)
Sponsors
Kyushu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ineligible/Intolerance for interferon-based therapy 2. Non-virological response for the past interferon-based treatment 3. This study will be explained and informed consent needs to be obtained from all the patients.
Exclusion criteria
Exclusion criteria: 1. Decompensated cirrhosis (Child B or C) 2. ALT level of more than five times the upper limit of normal range 3. Severe kidney damage (eGFR<30) 4. Coinfection with HBV or HIV 5. Women with pregnancy or breast feeding 6. Patients using contraindication drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virological response (SVR) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy and safety for patients with older or CKD (HD) 2. Predictive factor of SVR 3. Evaluation of adverse effects 4. Relationship between treatment outcome and HCV resistance-associated substitutions to daclatasvir | — |
Countries
Japan
Contacts
Public ContactEiichi Ogawa
Kyushu University Hospital Department of General Internal Medicine
Outcome results
None listed