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

NCT02992457 | Completed Phase 4 DMC

• 1 other identifier: Asem Elfert
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Number of patients with sustained virological response.

  The number of patients achieving SVR

  2 months

Study Arms (7)

Sof-Riba

ACTIVE COMPARATOR

Sofosbuvir ribavirin 6 months.

Drug: Sofosbuvir; Drug: Ribavirin

Sof- Riba- Pegylated interferon

ACTIVE COMPARATOR

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

Drug: Sofosbuvir; Drug: Ribavirin; Drug: Pegylated-interferon alfa-2a

Sof- Olysio

ACTIVE COMPARATOR

Sofosbuvir and simeprevir for 3 months.

Drug: Sofosbuvir; Drug: Simeprevir

Sof- Dacla

ACTIVE COMPARATOR

Sofosbuvir and Daclatasvir for 3 months.

Drug: Sofosbuvir; Drug: Daclatasvir

Harvony

ACTIVE COMPARATOR

Sofosbuvir and ledipasvir for 3 months

Drug: Sofosbuvir and Ledipasvir

Ritaprevir, paritaprevir, ombetasvir

ACTIVE COMPARATOR

Querevo for 3 months

Drug: Ritaprevir, paritaprevir, ombetasvir

Salvage therapy

ACTIVE COMPARATOR

sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo

Drug: Salvage therapy

Interventions

Sofosbuvir DRUG

Sofosbuvir 400 mg daily.

Also known as: sovaldi , mpiviropack

Sof- Dacla; Sof- Olysio; Sof- Riba- Pegylated interferon; Sof-Riba

Ribavirin DRUG

Ribavirin 1000-1200 mg daily

Also known as: Rebetol, Riba

Sof- Riba- Pegylated interferon; Sof-Riba

Pegylated-interferon alfa-2a DRUG

Pegylated interferon alfa-2a once weekly for 3 months

Also known as: peginteron, pegasys

Sof- Riba- Pegylated interferon

Simeprevir DRUG

Olysio once daily.

Also known as: Olysio

Sof- Olysio

Daclatasvir DRUG

Dakla once daily for three months.

Also known as: Daklatasvir, Dakla

Sof- Dacla

Ritaprevir, paritaprevir, ombetasvir DRUG

Querevo for three months

Also known as: querevo

Ritaprevir, paritaprevir, ombetasvir

Sofosbuvir and Ledipasvir DRUG

Once daily for three months

Also known as: Harvony

Harvony

Salvage therapy DRUG

three months in repeated treatment failure

Also known as: Sofosbuvir,simeprevir, daclatasvir, ribavirin or sofosbuvir and querevo

Salvage therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCV infection
• Adult patients, 18years and older.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tanta University: lead

Study Sites (2)

Sherief Abd-Elsalam

Tanta, Egypt

Location

Tanta university hospital

Tanta, Egypt

Location

Related Publications (2)

• Said EM, Abdulaziz BA, El Kassas M, El Attar IH, Emadeldeen M, Abd-Elsalam SM. High success rates for the use of sofosbuvir/ombitasvir/paritaprevir/ritonavir + ribavirin and sofosbuvir/simeprevir/daclatasvir + ribavirin in retreatment of chronic hepatitis C infection after unsuccessful sofosbuvir/daclatasvir therapy: a real-life experience. Arch Virol. 2020 Jul;165(7):1633-1639. doi: 10.1007/s00705-020-04639-x. Epub 2020 Apr 30.

  PMID: 32356185 DERIVED

• Ahmed OA, Kaisar HH, Badawi R, Hawash N, Samir H, Shabana SS, Fouad MHA, Rizk FH, Khodeir SA, Abd-Elsalam S. Efficacy and safety of sofosbuvir-ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection. Infect Drug Resist. 2018 Mar 1;11:295-298. doi: 10.2147/IDR.S153060. eCollection 2018.

  PMID: 29535545 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir; Ribavirin; peginterferon alfa-2a; Simeprevir; daclatasvir; paritaprevir; ledipasvir, sofosbuvir drug combination; Salvage Therapy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Officials

• Asem Elfert, Prof

  Tanta university hospital

  STUDY CHAIR

• Lobna Abo ALi, Ass Prof

  Tanta university hospital

  STUDY CHAIR

• Sabry Abou Saif, Ass Prof

  Tanta university hospital

  STUDY CHAIR

• Taher Eldemerdash, Prof

  Tanta University hospital

  STUDY CHAIR

• Hala M Elsabagh, Prof

  Tanta University hospital

  STUDY CHAIR

• Mohamed Elkassas, Lecturer

  Helwan University

  STUDY CHAIR

• Eslam Esmail, Ass Lecturer

  Tanta University

  STUDY CHAIR

• Sherief Abd-Elsalam

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 14, 2016
• Study Start: January 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)