Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection

August 23, 2023 updated by: Sherief Abd-Elsalam, Tanta University

Study of the Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With and Without Post-hepatitis C Cirrhosis

Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in Egypt. For decades the antiviral therapy of chronic HCV infection was based on the administration of Interferon(IFN), initially alone and then in combination with Ribavirin (RBV), but this regimen was effective in only 50% of patients with genotype 1, with significant side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in Egypt. For decades the antiviral therapy of chronic HCV infection was based on the administration ofInterferon(IFN), initially alone and then in combination with Ribavirin (RBV), but this regimen was effective in only 50% of patients with genotype 1, with significant side effects. The introduction of direct acting antiviral agents, in particular sofosbuvir (SOF), has revolutionized the treatment for chronic hepatitis C virus.

Study Type

Interventional

Enrollment (Actual)

10000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Tanta University Hospital
      • Tanta, Egypt
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • HCV infection

    • Adult patients, 18years and older.

Exclusion Criteria:

  • • Child score > 12

    • Severe Renal impairment
    • Pregnant and lactating women
    • HCC or other malignant neoplasms
    • Co-infection with human immunodeficiency virus (HIV)
    • Co-infection with hepatitis B virus (HBV)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sof-Riba
Sofosbuvir ribavirin 6 months.
Drug: Sofosbuvir
Sofosbuvir 400 mg daily.
Other Names:
  • sovaldi , mpiviropack
Drug: Ribavirin
Ribavirin 1000-1200 mg daily
Other Names:
  • Rebetol, Riba
Active Comparator: Sof- Riba- Pegylated interferon
Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months
Drug: Sofosbuvir
Sofosbuvir 400 mg daily.
Other Names:
  • sovaldi , mpiviropack
Drug: Ribavirin
Ribavirin 1000-1200 mg daily
Other Names:
  • Rebetol, Riba
Drug: Pegylated-interferon alfa-2a
Pegylated interferon alfa-2a once weekly for 3 months
Other Names:
  • peginteron, pegasys
Active Comparator: Sof- Olysio
Sofosbuvir and simeprevir for 3 months.
Drug: Sofosbuvir
Sofosbuvir 400 mg daily.
Other Names:
  • sovaldi , mpiviropack
Drug: Simeprevir
Olysio once daily.
Other Names:
  • Olysio
Active Comparator: Sof- Dacla
Sofosbuvir and Daclatasvir for 3 months.
Drug: Sofosbuvir
Sofosbuvir 400 mg daily.
Other Names:
  • sovaldi , mpiviropack
Drug: Daclatasvir
Dakla once daily for three months.
Other Names:
  • Daklatasvir, Dakla
Active Comparator: Harvony
Sofosbuvir and ledipasvir for 3 months
Drug: Sofosbuvir and Ledipasvir
Once daily for three months
Other Names:
  • Harvony
Active Comparator: Ritaprevir, paritaprevir, ombetasvir
Querevo for 3 months
Drug: Ritaprevir, paritaprevir, ombetasvir
Querevo for three months
Other Names:
  • querevo
Active Comparator: Salvage therapy
sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo
Drug: Salvage therapy
three months in repeated treatment failure
Other Names:
  • Sofosbuvir,simeprevir, daclatasvir, ribavirin or sofosbuvir and querevo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with sustained virological response.
Time Frame: 2 months
The number of patients achieving SVR
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Study Chair: Asem Elfert, Prof, Tanta University Hospital
  • Study Chair: Lobna Abo ALi, Ass Prof, Tanta University Hospital
  • Study Chair: Sabry Abou Saif, Ass Prof, Tanta University Hospital
  • Study Chair: Taher Eldemerdash, Prof, Tanta University Hospital
  • Study Chair: Hala M Elsabagh, Prof, Tanta University Hospital
  • Study Chair: Mohamed Elkassas, Lecturer, Helwan University
  • Study Chair: Eslam Esmail, Ass Lecturer, Tanta University
  • Principal Investigator: Sherief Abd-Elsalam, Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 10, 2016

First Posted (Estimated)

December 14, 2016

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Asem Elfert

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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