Efficacy and safety of Sofosbuvir / Velpatasvir combination therapy for type C decompensated cirrhosis
- Conditions
- type C decompensated cirrhosis
- Registration Number
- JPRN-UMIN000038587
- Lead Sponsor
- ippon Medical School, Division of Gastroenterology and Hepatology, Department of Internal Medicine
- Brief Summary
Twelve weeks of sofosbuvir/velpatasvir in real-world clinical practice yielded high SVR rates and acceptable safety profiles in decompensated cirrhotic patients with genotypes 1 and 2. Achievement of SVR not only restored the liver functional reserve but also reduced or spared the administration of drugs for related complications.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
Not provided
(1)Patients with a history of hypersensitivity to the ingredients of this drug (2)Patients with severe renal dysfunction (eGFR <30 mL / min / 1.73m2) or renal failure requiring dialysis (3)Patients taking the following drugs Foods containing carbamazepine, phenytoin, phenobarbital, rifampicin, hypericum (St. John's wort) (4)Patient who is pregnant or breastfeeding (5)Patients with hepatocellular carcinoma and other cancers (6)patients who are judged to be inappropriate for participation in the study by the study doctor
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SVR12 rate (Percent of patients with negative HCV RNA 12 weeks after the end of treatment)
- Secondary Outcome Measures
Name Time Method (1) Patient background: age, sex, height, weight, complications, medical history (2) Subjective symptoms (3) Presence or absence of liver-related complications: hepatic edema, hepatic encephalopathy, esophageal / gastric varices (4) Clinical laboratory items