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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992457
• Other study ID #: Asem Elfert
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: December 2019

Study information

• Verified date: August 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Sofosbuvir
Sofosbuvir 400 mg daily.
• Ribavirin
Ribavirin 1000-1200 mg daily
• Pegylated-interferon alfa-2a
Pegylated interferon alfa-2a once weekly for 3 months
• Simeprevir
Olysio once daily.
• Daclatasvir
Dakla once daily for three months.
• Ritaprevir, paritaprevir, ombetasvir
Querevo for three months
• Sofosbuvir and Ledipasvir
Once daily for three months
• Salvage therapy
three months in repeated treatment failure

Locations

Country	Name	City	State
Egypt	Sherief Abd-Elsalam	Tanta
Egypt	Tanta university hospital	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with sustained virological response.	The number of patients achieving SVR	2 months