Safety and Efficacy of Different Antiviral Regimens for Hepatitis C Virus Relapse

• Conditions: Hepatitis C; Relapse; Antivirals

• Registration Number: NCT04662138
• Lead Sponsor: Alexandria University

Brief Summary

The primary goal of hepatitis C virus (HCV) Direct Acting Antivirals (DAAs) is to achieve undetectable HCV RNA in the blood. A response that should be maintained for at least 12 weeks from completion of therapy. This is called sustained virological response (SVR) which corresponds to cure of HCV infection as risk of later relapse is very small. SVR is important to achieve improvement in liver necroinflammation and fibrosis and to decrease complications of cirrhosis.

Failing to achieve SVR after treatment requires another regimen for these experienced patients.

Real-world data are always needed to evaluate and improve our practices. Here investigators aim to assess tolerability and efficacy of different regimens used for management of genotype 4 HCV relapse.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08-24
• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-04
• Last Update Submitted: 2020-12-04
• Study First Posted: 2020-12-10
• Last Update Posted: 2020-12-10
• Primary Completion: 2022-05-28
• Study Completion: 2022-05-28

Recruitment & Eligibility

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

Inclusion Criteria

• all patients with HCV relapse after sofosbuvir plus either Non-structural protein 5 A (NS5A) or protease inhibitor.

Exclusion Criteria

• No exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained virological response	12 weeks after completion of treatment

Trial Locations

Locations (1)

Alexandria University.; 🇪🇬 Alexandria, Egypt