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

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.

Conditions

• Hepatitis C

Interventions

DRUG

Sofosbuvir

Sofosbuvir 400 mg daily.

DRUG

Ribavirin

Ribavirin 1000-1200 mg daily

DRUG

Pegylated-interferon alfa-2a

Pegylated interferon alfa-2a once weekly for 3 months

DRUG

Simeprevir

Olysio once daily.

DRUG

Daclatasvir

Dakla once daily for three months.

DRUG

Ritaprevir, paritaprevir, ombetasvir

Querevo for three months

DRUG

Sofosbuvir and Ledipasvir

Once daily for three months

DRUG

Salvage therapy

three months in repeated treatment failure

Sponsors & Collaborators

• Tanta University

  lead OTHER

Principal Investigators

• Asem Elfert, Prof · Tanta university hospital

• Lobna Abo ALi, Ass Prof · Tanta university hospital

• Sabry Abou Saif, Ass Prof · Tanta university hospital

• Taher Eldemerdash, Prof · Tanta University hospital

• Hala M Elsabagh, Prof · Tanta University hospital

• Mohamed Elkassas, Lecturer · Helwan University

• Eslam Esmail, Ass Lecturer · Tanta University

• Sherief Abd-Elsalam · Tanta University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2018-12-31

Completion

2019-12-31

Countries

• Egypt

Study Locations