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

Sun Yat-sen University

Status: Unknown

Conditions: Hepatitis C

Treatments: Drug: Epclusa (sofosbuvir and velpatasvir)

Study type: Observational

Funder types: Other

Identifiers

NCT04948801

[2018]02-417-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

150 participants in 3 patient groups

genotype 3a HCV

Description:

genotype 3a hepatitis C

Treatment:

Drug: Epclusa (sofosbuvir and velpatasvir)

genotype 6 HCV

Description:

genotype 6 hepatitis C

Treatment:

Drug: Epclusa (sofosbuvir and velpatasvir)

genotype 3b HCV

Description:

genotype 3b hepatitis C

Treatment:

Drug: Epclusa (sofosbuvir and velpatasvir)