Trial | NCT02992457  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    10000
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.
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 Started
Jan 31
2015
Primary Completion
Dec 31
2018
Study Completion
Dec 31
2019
Last Update
Aug 25
2023

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

Drug Simeprevir

Olysio once daily.

  • Other names: Olysio

Drug Daclatasvir

Dakla once daily for three months.

  • Other names: Daklatasvir, Dakla

Drug Ritaprevir, paritaprevir, ombetasvir

Querevo for three months

  • Other names: querevo

Drug Sofosbuvir and Ledipasvir

Once daily for three months

  • Other names: Harvony

Drug Salvage therapy

three months in repeated treatment failure

  • Other names: Sofosbuvir,simeprevir, daclatasvir, ribavirin or sofosbuvir and querevo

Sof-Riba Active Comparator

Sofosbuvir ribavirin 6 months.

Sof- Riba- Pegylated interferon Active Comparator

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

Sof- Olysio Active Comparator

Sofosbuvir and simeprevir for 3 months.

Sof- Dacla Active Comparator

Sofosbuvir and Daclatasvir for 3 months.

Harvony Active Comparator

Sofosbuvir and ledipasvir for 3 months

Ritaprevir, paritaprevir, ombetasvir Active Comparator

Querevo for 3 months

Salvage therapy Active Comparator

sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo

Criteria 

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)
No Results Posted