Very Rapid and Rapid Virological Response as Predictors of Response of HCV Tretment

• Conditions: Predictors of Response to HCV Tretment

• Registration Number: NCT03480269
• Lead Sponsor: Assiut University

Brief Summary

assessment of very rapid virological response and rapid virological response as predictors of response to sofosbuvir and daclatasvir in treatment of cirrhotic and non-cirrhotic patients with HCV, eligible to treatment.

Detailed Description

Chronic hepatitis C infection (CHC) is a global health problem, with an estimated 120 to 130 million chronic hepatitis C virus (HCV) carriers worldwide Therefore, early recognition and effective management of the disease can modify its natural history

. There is a growing body of evidence that suggests that treatment will help reduce liver inflammation, may reverse liver damage (scarring),slow down disease progression and improve symptoms and quality of life. All of these factors are important reasons to seek HCV medical treatment Identifying host-viral factors that predict the likelihood of SVR prior to initiating therapy would be a very useful clinical tool that could help reduce costs and avoid unnecessary exposure to therapy with significant side effects Little is known about predictors of failure to achieve SVR with DAAs. Although numerous clinical parameters predicted poor response to pegylated IFN treatment , none of them have been shown to be associated with virological relapse after DAA based therapy

Treatment response terms:

The ultra rapid virological response (uRVR) is a new endpoint that we defined as an undetectable serum HCV RNA at the end of 1st week of therapy.

The very rapid virologic response( vRVR )defined as undetectable serum HCV RNA level at week 2.

The rapid virological response (RVR) defined as undetectable serum HCV RNA after 4 weeks of treatment sustained virological response (SVR), which is defined by the undetectable serum HCV RNA 12-24 weeks after the end of treatment Relapser was defined as undetectable viral load at the end of DAA treatment but subsequent detectable viral load at 12 weeks after treatment end.

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-29
• Last Update Submitted: 2018-07-05
• Last Update Posted: 2018-07-06
• Study Start: 2018-08-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Anti HCV positive patients either chronic HCV or liver cirrhosis.
• Detectable HCV RNA by quantitative PCR prior to treatment.
• Naïve patients (not received any HCV treatment regimen before)

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Exclusion Criteria

• Patients with hepatocellular carcinoma( HCC)
• Patients with combined HBV and HCV

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rapid virological response (undetected HCV RNA after 4 weeks from the begin of antiviral treatment)	April 2018 to April 2019	To assess rapid virological response as a predictor of response to sofosbuvir and daclatasvir in treatment of cirrhotic and non-cirrhotic patients with HCV. It measure the relation between rapid virological response and achievment of sustained virological response (Undetected HCV RNA 12-24 weeks after the end of treatment )