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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02992457

Enrollment

10000

Registered

2016-12-14

Start date

2015-01-31

Completion date

2019-12-31

Last updated

2023-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

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.

Interventions

DRUGSofosbuvir

Sofosbuvir 400 mg daily.

DRUGRibavirin

Ribavirin 1000-1200 mg daily

DRUGPegylated-interferon alfa-2a

Pegylated interferon alfa-2a once weekly for 3 months

DRUGSimeprevir

Olysio once daily.

DRUGDaclatasvir

Dakla once daily for three months.

DRUGRitaprevir, paritaprevir, ombetasvir

Querevo for three months

DRUGSofosbuvir and Ledipasvir

Once daily for three months

DRUGSalvage therapy

three months in repeated treatment failure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with sustained virological response.	2 months	The number of patients achieving SVR

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026