drugset / Trial / NCT02992457

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

NCT02992457

Phase 4 Completed 10000 enrolled Tanta University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-01
Primary completion
2018-12
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Daclatasvir Small molecule
Comparator Ledipasvir Small molecule
Comparator Peginterferon alfa-2a Protein / enzyme biologic
Comparator Ribavirin Small molecule 1000 mg
Comparator Ribavirin Small molecule 1200 mg
Comparator Ritaprevir Unknown
Comparator Simeprevir Small molecule
Comparator Sofosbuvir Small molecule 400 mg
Comparator ombetasvir Unknown
Comparator paritaprevir Small molecule