Long Term Follow up of Chronic HCV Patients Receiving DAAS

Long Term Follow up of Chronic Hepatitis C Patients Treated With Direct Acting Antivirals After Sustained Virological Response

Follow up of Chronic hepatitis C Patients with moderate to severe fibrosis and cirrhosis treated with Direct Acting Antivirals after Sustained Virological Response for 4-5 years to detect changes in hepatic fibrosis and liver functions.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis c

Detailed Description

Treatment of chronic hepatitis C is evolving rapidly. Three classes of direct-acting antiviral agents, including inhibitors of the HCV NS3/4A protease, NS5B polymerase, and NS5A have been approved for the treatment of patients with chronic hepatitis C, both in combination with pegylated Interferon (Peg-IFN) / ribavirin (RBV) and, recently, in interferon-free combination.

The objective of chronic hepatitis C treatment is to achieve SVR which is defined as the absence of viral replication at 12 or 24 weeks after treatment completion. SVR reduces morbidity and mortality and is equivalent in most cases to cure the HCV infection. Studies have demonstrated that SVR is associated with histological improvement, assessed by liver biopsy, and with the prevention of complications, such as the development of liver cirrhosis and HCC.

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

Contacts and Locations

• Study Contact: Name: Amira Maher, MD; Phone Number: 00201006789652; Email: amiramaher@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag university Hospital
    • Contact: Amira Maher, MD; Phone Number: 00201006789652; Email: amiramaher@med.edu.sohag.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: Probability Sample

Study Population

adult patients with chronic hepatitis C who received direct-acting antiviral drugs and scheived SVR

Description

Inclusion Criteria:

• Chronic HCV patients with moderate to severe hepatic fibrosis (F2: F4) or cirrhosis who received direct-acting antivirals and achieved SVR.

Exclusion Criteria:

• Other liver diseases as Chronic hepatitis B and autoimmune liver disease. HIV co-infection.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in hepatic fibrosis	Shear wave elastography	4 years after end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in serum albumin level	change in liver function	4 years after end of treatment
change in prothrombin level	change in liver function	4 years after end of treatment
change in bilirubin level	change in liver function	4 years after end of treatment

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: December 24, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic
• Other Study ID Numbers: DAAS in HCV patients

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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