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

Tanta University

Status and phase: Completed; Phase 4

Conditions: Hepatitis C

Treatments: Drug: Pegylated-interferon alfa-2a; Drug: Ribavirin; Drug: Ritaprevir, paritaprevir, ombetasvir; Drug: Salvage therapy; Drug: Simeprevir; Drug: Daclatasvir; Drug: Sofosbuvir; Drug: Sofosbuvir and Ledipasvir

Study type: Interventional

Funder types: Other

Identifiers

NCT02992457

Asem Elfert

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,000 participants in 7 patient groups

Sof-Riba

Active Comparator group

Description:

Sofosbuvir ribavirin 6 months.

Treatment:

Drug: Sofosbuvir

Drug: Ribavirin

Sof- Riba- Pegylated interferon

Active Comparator group

Description:

Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months

Treatment:

Drug: Sofosbuvir

Drug: Pegylated-interferon alfa-2a

Drug: Ribavirin

Sof- Olysio

Active Comparator group

Description:

Sofosbuvir and simeprevir for 3 months.

Treatment:

Drug: Sofosbuvir

Drug: Simeprevir

Sof- Dacla

Active Comparator group

Description:

Sofosbuvir and Daclatasvir for 3 months.

Treatment:

Drug: Sofosbuvir

Drug: Daclatasvir

Harvony

Active Comparator group

Description:

Sofosbuvir and ledipasvir for 3 months

Treatment:

Drug: Sofosbuvir and Ledipasvir

Ritaprevir, paritaprevir, ombetasvir

Active Comparator group

Description:

Querevo for 3 months

Treatment:

Drug: Ritaprevir, paritaprevir, ombetasvir

Salvage therapy

Active Comparator group

Description:

sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo

Treatment:

Drug: Salvage therapy