SOF/VEL±RBV: Efficacy and Safety in GT 3 and 6 HCV Patients

• Conditions: Hepatitis C
• Interventions: Drug: Epclusa (sofosbuvir and velpatasvir)

• Registration Number: NCT04948801
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

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 Timeline

• Study Start: 2018-12-08
• Study First Submitted: 2021-03-16
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Study First Posted: 2021-07-02
• Last Update Posted: 2021-07-02
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
genotype 3a HCV	Epclusa (sofosbuvir and velpatasvir)	genotype 3a hepatitis C
genotype 6 HCV	Epclusa (sofosbuvir and velpatasvir)	genotype 6 hepatitis C
genotype 3b HCV	Epclusa (sofosbuvir and velpatasvir)	genotype 3b hepatitis C

Primary Outcome Measures

Name	Time	Method
SVR12	12 weeks	HCV RNA \<LLOQ at Week 12 after cessation of treatment

Trial Locations

Locations (1)

Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China