drugset / Trial / NCT02992457
Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-01
- Primary completion
- 2018-12
- Completion
- 2019-12
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Daclatasvir | Small molecule | — | — |
| Comparator | Ledipasvir | Small molecule | — | — |
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | — | — |
| Comparator | Ribavirin | Small molecule | 1000 mg | — |
| Comparator | Ribavirin | Small molecule | 1200 mg | — |
| Comparator | Ritaprevir | Unknown | — | — |
| Comparator | Simeprevir | Small molecule | — | — |
| Comparator | Sofosbuvir | Small molecule | 400 mg | — |
| Comparator | ombetasvir | Unknown | — | — |
| Comparator | paritaprevir | Small molecule | — | — |