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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Sofosbuvir
* Drug: Ribavirin
* Drug: Pegylated-interferon alfa-2a
* Drug: Simeprevir
* Drug: Daclatasvir
* Drug: Ritaprevir, paritaprevir, ombetasvir
* Drug: Sofosbuvir and Ledipasvir
* Drug: Salvage therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sof-Riba<br>Sofosbuvir ribavirin 6 months. | Drug: Sofosbuvir<br>* Sofosbuvir 400 mg daily.<br>* Other names: sovaldi , mpiviropack;Drug: Ribavirin<br>* Ribavirin 1000-1200 mg daily<br>* Other names: Rebetol, Riba;|
| Active Comparator: Sof- Riba- Pegylated interferon<br>Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months | Drug: Sofosbuvir<br>* Sofosbuvir 400 mg daily.<br>* Other names: sovaldi , mpiviropack;Drug: Ribavirin<br>* Ribavirin 1000-1200 mg daily<br>* Other names: Rebetol, Riba;Drug: Pegylated-interferon alfa-2a<br>* Pegylated interferon alfa-2a once weekly for 3 months<br>* Other names: peginteron, pegasys;|
| Active Comparator: Sof- Olysio<br>Sofosbuvir and simeprevir for 3 months. | Drug: Sofosbuvir<br>* Sofosbuvir 400 mg daily.<br>* Other names: sovaldi , mpiviropack;Drug: Simeprevir<br>* Olysio once daily.<br>* Other names: Olysio;|
| Active Comparator: Sof- Dacla<br>Sofosbuvir and Daclatasvir for 3 months. | Drug: Sofosbuvir<br>* Sofosbuvir 400 mg daily.<br>* Other names: sovaldi , mpiviropack;Drug: Daclatasvir<br>* Dakla once daily for three months.<br>* Other names: Daklatasvir, Dakla;|
| Active Comparator: Harvony<br>Sofosbuvir and ledipasvir for 3 months | Drug: Sofosbuvir and Ledipasvir<br>* Once daily for three months<br>* Other names: Harvony;|
| Active Comparator: Ritaprevir, paritaprevir, ombetasvir<br>Querevo for 3 months | Drug: Ritaprevir, paritaprevir, ombetasvir<br>* Querevo for three months<br>* Other names: querevo;|
| Active Comparator: Salvage therapy<br>sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo | Drug: Salvage therapy<br>* three months in repeated treatment failure<br>* Other names: Sofosbuvir,simeprevir, daclatasvir, ribavirin or sofosbuvir and querevo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with sustained virological response. | The number of patients achieving SVR | 2 months |