Clinical trial NCT03884062: Clinical Impacts of Achieving SVR in Patients With Advanced Hepatic Fibrosis Related to Chronic HCV Treated With Direct Acting Antivirals
Official title: Clinical Impacts of Achieving Sustained Virological Response in Patients With Advanced Hepatic Fibrosis Related to Chronic HCV Treated With Direct Acting Antivirals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCC in Chronic HCV Patients With Advanced Liver Fibrosis
Keywords: HCC, chronic hepatitis C, hepatitis C, liver fibrosis
Lead sponsor: Egyptian Liver Hospital
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 3000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all subjects from screening with positive HCV whom received treatment for 12/24 week with DAAs

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

Eligibility criteria: 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

Primary outcomes:
measure: Detection of HCC by CT
timeFrame: 12-45 months after SVR
Secondary outcomes:
measure: fibrosis stage changes by Fibroscan
timeFrame: 12-45 months after SVR
Other outcomes:
Locations:
Study officials:
References: