Clinical Impacts of Achieving SVR in Patients With Advanced Hepatic Fibrosis Related to Chronic HCV Treated With Direct Acting Antivirals

Completed

• Conditions: HCC in Chronic HCV Patients With Advanced Liver Fibrosis
• Interventions: Drug: DAAs

• Registration Number: NCT03884062
• Lead Sponsor: Egyptian Liver Hospital

Brief Summary

Chronic HCV infection has relatively slow rate of progression. Liver fibrosis is the main sequlae and usually progressed to cirrhosis after long period (10 to 20 years) \[6\]. Once cirrhosis is established the disease progression remains unpredictable: cirrhosis can remain indolent for many years in some patients whilst progressing in others to HCC, hepatic decompensation and death. Overall once cirrhosis has developed there is a 1-5% annual risk of HCC and a 3-6% annual risk of hepatic decompensation. Following an episode of decompensation the risk of death in the following year is between 15% and 20% Treatment of chronic HCV has been dramatically changed in the last few years with introduction of direct acting antivirals (DAAs). The new therapies with excellent safety profiles, shorter duration of therapy and marked higher efficacy can be even used in patients with advanced fibrosis and cirrhosis

Detailed Description

Chronic HCV infection has relatively slow rate of progression. Liver fibrosis is the main sequlae and usually progressed to cirrhosis after long period (10 to 20 years) \[6\]. Once cirrhosis is established the disease progression remains unpredictable: cirrhosis can remain indolent for many years in some patients whilst progressing in others to HCC, hepatic decompensation and death. Overall once cirrhosis has developed there is a 1-5% annual risk of HCC and a 3-6% annual risk of hepatic decompensation. Following an episode of decompensation the risk of death in the following year is between 15% and 20% Treatment of chronic HCV has been dramatically changed in the last few years with introduction of direct acting antivirals (DAAs). The new therapies with excellent safety profiles, shorter duration of therapy and marked higher efficacy can be even used in patients with advanced fibrosis and cirrhosis

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2018-06-01
• Study Completion: 2019-01-01
• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-07
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• above 12 years old
• fibroscan F3 or F4
• HCV positive
• Received DAAs

Exclusion Criteria

• below 12 years old
• fibroscan below F3
• HCV negative

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DAAs-SVR.	DAAs	annual incidence of HCC in chronic hepatitis C patients with advanced liver fibrosis (F3 and F4) after achieving DAAs-SVR.

Primary Outcome Measures

Name	Time	Method
Detection of HCC by CT	12-45 months after SVR	incidence of HCC in chronic hepatitis C patients with advanced liver fibrosis (F3 and F4) after achieving DAAs-SVR

Secondary Outcome Measures

Name	Time	Method
fibrosis stage changes by Fibroscan	12-45 months after SVR	post treatment fibrosis stage in chronic hepatitis C patients with advanced liver fibrosis (F3 and F4) after achieving DAAs-SVR