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

Safety and Efficacy of Directly Acting Antiviral Agents in Genotype 4 Hepatitis C Virus Relapse Among Egyptian Patients

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.

Study Overview

• Status: Unknown
• Conditions: Hepatitis C; Relapse; Antivirals
• Intervention / Treatment: Drug: directly acting antivirals

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21131
    • Recruiting
    • Alexandria University.
    • Contact: Ahmed Kamal; Phone Number: 01279734654; Email: Ahmed.Kamal@alexmed.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with HCV relapse after sofosbuvir plus either NS5A or protease inhibitor who will start another HCV treatment at Alexandria University Viral Hepatitis Treatment Unit or Alexandria University Liver Clinics in the period from 24/8/2020 to 23/8/2021.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sustained virological response	12 weeks after completion of treatment

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2020
• Primary Completion (Anticipated): May 28, 2022
• Study Completion (Anticipated): May 28, 2022

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Recurrence; Anti-Infective Agents; Antiviral Agents
• Other Study ID Numbers: 0304769

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No