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

Phase 4

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Sofosbuvir and Ledipasvir; Drug: Salvage therapy; Drug: Sofosbuvir; Drug: Ritaprevir, paritaprevir, ombetasvir; Drug: Ribavirin; Drug: Simeprevir; Drug: Daclatasvir; Drug: Pegylated-interferon alfa-2a

• Registration Number: NCT02992457
• Lead Sponsor: Tanta University

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.

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-10
• Study First Posted: 2016-12-14
• Primary Completion: 2018-12
• Study Completion: 2019-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Harvony	Sofosbuvir and Ledipasvir	Sofosbuvir and ledipasvir for 3 months
Sof- Riba- Pegylated interferon	Ribavirin	Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months
Sof- Olysio	Simeprevir	Sofosbuvir and simeprevir for 3 months.
Salvage therapy	Salvage therapy	sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo
Sof-Riba	Sofosbuvir	Sofosbuvir ribavirin 6 months.
Sof- Olysio	Sofosbuvir	Sofosbuvir and simeprevir for 3 months.
Ritaprevir, paritaprevir, ombetasvir	Ritaprevir, paritaprevir, ombetasvir	Querevo for 3 months
Sof- Riba- Pegylated interferon	Pegylated-interferon alfa-2a	Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months
Sof-Riba	Ribavirin	Sofosbuvir ribavirin 6 months.
Sof- Riba- Pegylated interferon	Sofosbuvir	Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months
Sof- Dacla	Sofosbuvir	Sofosbuvir and Daclatasvir for 3 months.
Sof- Dacla	Daclatasvir	Sofosbuvir and Daclatasvir for 3 months.

Primary Outcome Measures

Name	Time	Method
Number of patients with sustained virological response.	2 months	The number of patients achieving SVR

Trial Locations

Locations (2)

Tanta university hospital; 🇪🇬 Tanta, Egypt

Sherief Abd-Elsalam; 🇪🇬 Tanta, Egypt