Clinical trial NCT02992457: Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection
Official title: Study of the Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With and Without Post-hepatitis C Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Number of patients with sustained virological response.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
city: Tanta
country: Egypt
facility: Tanta university hospital
Study officials:
affiliation: Tanta university hospital
name: Asem Elfert, Prof
role: STUDY_CHAIR
affiliation: Tanta university hospital
name: Lobna Abo ALi, Ass Prof
role: STUDY_CHAIR
affiliation: Tanta university hospital
name: Sabry Abou Saif, Ass Prof
role: STUDY_CHAIR
affiliation: Tanta University hospital
name: Taher Eldemerdash, Prof
role: STUDY_CHAIR
affiliation: Tanta University hospital
name: Hala M Elsabagh, Prof
role: STUDY_CHAIR
affiliation: Helwan University
name: Mohamed Elkassas, Lecturer
role: STUDY_CHAIR
affiliation: Tanta University
name: Eslam Esmail, Ass Lecturer
role: STUDY_CHAIR
affiliation: Tanta University
name: Sherief Abd-Elsalam
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.