SOF/VEL±RBV: Real-World Efficacy and Safety in GT 3 and 6 HCV Patients in China
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- SVR12
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
Arms & Interventions
genotype 3a HCV
genotype 3a hepatitis C
Intervention: Epclusa (sofosbuvir and velpatasvir) (Drug)
genotype 6 HCV
genotype 6 hepatitis C
Intervention: Epclusa (sofosbuvir and velpatasvir) (Drug)
genotype 3b HCV
genotype 3b hepatitis C
Intervention: Epclusa (sofosbuvir and velpatasvir) (Drug)
Outcomes
Primary Outcomes
SVR12
Time Frame: 12 weeks
HCV RNA \<LLOQ at Week 12 after cessation of treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Zhe-bin Wu
Professor
Third Affiliated Hospital, Sun Yat-Sen University