Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment (RELIF-C)

Sang Gyune Kim

Status

Unknown

Conditions

Chronic Hepatitis C

Treatments

Drug: Daclatasvir and Asunaprevir

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02865369

AI444-392

Details and patient eligibility

About

A study on regression of liver fibrosis assessed by transient elastography after Daclatasvir and Asunaprevir combined treatment in advanced fibrotic/cirrhotic patients with chronic hepatitis C genotype 1b Infection

Full description

The measurement of liver stiffness by transient elastography (TE) has been shown to correlate with the hepatic fibrosis stage and to have considerable accuracy for the diagnosis of cirrhosis in patients with chronic hepatitis C. Previous studied reported that liver stiffness is significantly reduced in SVR patients with pegylated interferon (IFN) and ribavirin treatment. Once a patient achieve sustained virological response (SVR), and resultingly lower liver stiffness score than baseline value, it is believed that he will have a better long-term outcome due to the improvement of liver fibrosis.

Daclatasvir(DCV) and Asunaprevir(ASV) combined treatment showed a greater SVR rate in CHC compared to IFN based therapy. The investigators hypothesize that DCV and ASV combined treatment may achieve the improvement of liver stiffness measured by TE and a more favorable clinical outcomes in patients with advanced liver fibrosis. The investigators will also compare the change of fibrosis stage assessed by TE between this study subjects and those treated with other DAA agents during same observational period.

Enrollment

103 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chronically infected with Hepatitis C virus genotype 1b
HCV RNA ≥ 10^4 IU/mL (10,000 IU/mL)
Chronic Hepatitis C with advanced fibrosis or cirrhosis (defined as ≥F3, ≥8 kilopascals)
Treatment-naïve or those who previously failed to treatment with peg-interferon alfa and ribavirin
Women of childbearing potential (WOCBP) and men, who use effective methods of birth control

Exclusion criteria

Patients with baseline key NS5A RAVs (Y93 and/or L31)
Estimated GFR < 30mL/min without hemodialysis
Alanine aminotransferase (ALT) > 100 IU/L
Coinfection with other hepatitis virus or human immunodeficiency virus
A daily alcohol intake >30 g
Decompensated liver disease or hepatocellular carcinoma, liver or any other organ transplantation