Hepatitis C
Conditions
Brief summary
150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated patients will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered Epclusa each plus Ribavirin for 12 weeks.
Detailed description
This is a Prospective, observational, multi-center, real-world study to investigate real world effectiveness and safety of SOF/VEL±RBV in Chinese patients infected by HCV GT-3 and 6. 150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated cirrhosis will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered one pill of Epclusa each plus Ribavirin for 12 weeks.Demographic, clinical, adverse event and virological data were be collected throughout treatment and post-treatment follow-up.
Interventions
Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* HCV RNA ≥ 15 IU/Ml at Screening * HCV genotype 3a ,3b and 6 * Hepatitis C without decompensated cirrhosis of the liver
Exclusion criteria
* Patients failed to previous NS5A-containing DAAs therapy * Decompensated cirrhosis * HCC * Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SVR12 | 12 weeks | HCV RNA \<LLOQ at Week 12 after cessation of treatment |
Countries
China
Contacts
Primary ContactZhang Xiao hong, Professor
Outcome results
None listed