Effect of Sofosbuvir or Ledipasvir/Sofosbuvir Therapy on Liver Fibrosis in Japanese Patients with Hepatitis C Virus Infectio

Not Applicable

• Conditions: chronic hepatitis C

• Registration Number: JPRN-UMIN000020048
• Lead Sponsor: Yokohama City University Medical Center

Brief Summary

A total of 98.1% of (n=101/103) patients in genotype 1 cohort and 100% (n=16/16) in the genotype 2 cohort achieved SVR12. Based on per-protocol analysis, M2BPGi levels showed a significant decrease (-2.2 cut-off index [COI], P<.0001) at week 48 after treatment initiation. Forty-three patients showed a significant decrease in Fib-4 index (-1.2, P<.0001), and 44 patients showed improvement in LSM (-5.9 kPa, P<.0001).Achievement of SVR after antiviral therapy was associated with fibrosis regression.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-04
• Study Completion: 2018-05-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

Not provided

Exclusion Criteria

1.Co-infection with hepatitis B virus or human immunodeficiency virus, other chronic liver disease 2.Evidence of hepatic decompensation (Child-Pugh classification B or C). 3.Using interferon and ribavirin during this study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the regression of liver fibrosis in patients with HCV infection who have achieved SVR with sofosbuvir or ledipasvir/sofosbuvir at Week 48 after treatment initiation. Liver fibrosis was measured using multiple tests, including FastLec-Hepa and analysis of other fibrosis markers (platelet count, hyaluronic acid, the FIB-4 index, type IV collagen, Fibroscan, SWE).

Secondary Outcome Measures

Name	Time	Method
1.To evaluate the regression of liver fibrosis in patients HCV infection who have achieved SVR with sofosbuvir or ledipasvir/sofosbuvir at Week 4, 8, 12, 24, and 36 after treatment initiation (FastLec-Hepa (M2BPGi), platelet count, hyaluronic acid, the FIB-4 index, type IV collagen, Fibroscan, SWE). 2.Safety 3.SVR12 rate, SVR24 rate 4.HCC incidence rate