Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment

Sang Gyune Kim103 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

103

Conditions

Chronic Hepatitis C

Interventions

Daclatasvir and AsunaprevirDRUG

Daclatasvir and Asunaprevir combined treatment will not be assigned to the enrolled patients, but the patients who are treated with Daclatasvir and Asunaprevir will be included in this observational study.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (10)

Soonchunhyang University Cheonan Hospital

Cheonan, Chungcheongnam-do, South Korea

Korea University Ansan Hospital

Ansan, Gyeonggi-do, South Korea

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

The change of liver fibrosis stage at 48 weeks assessed by transient elastography in patients treated with Daclatasvir and Asunaprevir

To compare the change of liver fibrosis stage (defined as F3, ≥8; F4, ≥12) assessed by transient elastography between baseline and 48 weeks in advanced fibrotic/cirrhotic Chronic Hepatitis C patients who achieved sustained virological response with Daclatasvir and Asunaprevir combined treatment

Time frame: baseline to 48weeks

Secondary Outcomes

Proportion of patients who were treated with Daclatasvir and Asunaprevir achieved SVR12 assessed by HCV RNA

Time frame: baseline to 36 weeks

Proportion of patients who maintained sustained virologic response at SVR24, SVR72, SVR120, SVR168, and SVR216.

Time frame: baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks

The change of liver fibrosis stage assessed by transient elastography at 96weeks, 144weeks, 192weeks, 240weeks in patients treated with Daclatasvir and Asunaprevir

Time frame: baseline to 96weeks, 144weeks, 192weeks, 240weeks

The change of AST to Platelet Ratio Index

APRI = \[(AST/upper limit of normal)/platelet count\]x100

Time frame: baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks

The change of Fibrosis 4 (Fib-4) index

FIB-4 = age (years) × AST \[IU/L\] / \[platelet count × sqr(ALT \[IU/L\])\]

Time frame: baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks

Comparison of change of liver fibrosis stage assessed by transient elastography between Daclatasvir and Asunaprevir combined treatment versus other DAA treatment

Central Contacts

Sang Gyune Kim, Professor

CONTACT

82-32-621-5071 mcnulty@schmc.ac.kr

Data from ClinicalTrials.gov

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