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

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT02992457

Collaborator

(none)

10,000

Enrollment

Locations

Arms

Actual Duration (Months)

5000

Patients Per Site

84.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: Sofosbuvir Drug: Ribavirin Drug: Pegylated-interferon alfa-2a Drug: Simeprevir Drug: Daclatasvir Drug: Ritaprevir, paritaprevir, ombetasvir Drug: Sofosbuvir and Ledipasvir Drug: Salvage therapy	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

10000 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

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