Efficacy and safety of Ledipasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 2 Infectio
Not Applicable
- Conditions
- Patients With Hepatitis C Virus Genotype 2 Infection
- Registration Number
- JPRN-UMIN000038604
- Lead Sponsor
- Ogaki Municipal Hospital
- Brief Summary
The overall SVR rates of the ITT and mITT populations were 87.3% (95% confidence interval [CI] 80.2-92.6) (110/126) and 97.3% (95% CI 92.4-99.4) (110/113), respectively. In the mITT population, the percentages of patients with undetectable HCV RNA at 4, 8, and 12 weeks after the start of therapy were 92.9% (95% CI 86.5-96.9) (105/113), 99.1% (95% CI 95.2-100.0) (112/113), and 100.0% (95% CI 97.4-100.0) (113/113), respectively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 126
Inclusion Criteria
Not provided
Exclusion Criteria
Prior exposure to a direct-acting antiviral agent targeting HCV NS5A or NS5B Decompensated cirrhosis Creatinine clearance (Cockcroft-Gault) less than 30 mL/min
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and efficacy of ledipasvir-sofosbuvir for 12 weeks treatment with Japanese GT2 patients
- Secondary Outcome Measures
Name Time Method Completion rate for treatment completion (without discontinuation of safety reason).