NCT03069001

Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV

Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Egyptian Patients With HCV

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This prospective study was conducted at Ain Shams University Hospital, Internal Medicine, Hepatology and Gastroenterology Department, and Tropical Medicine Department. To compare the efficacy of the combination of sofosbuvir and simeprevir for 12 weeks with the combination of sofosbuvir and ribavirin for 24 weeks in Egyptian patients with HCV-related Child A cirrhosis.

Conditions

• HCV

Interventions

Type	Name	Description
DRUG	Sofosbuvir-Simeprevir	-Sofosbuvir-Simeprevir group included 50 patients who received sofosbuvir 400 mg orally once-daily plus simeprevir 150 mg orally once-daily for 12 weeks.
DRUG	Sofosbuvir-Ribavirin	-Sofosbuvir-Ribavirin group included 40 patients who received sofosbuvir 400 mg orally once-daily plus ribavirin orally twice-daily for 24 weeks.

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2017-03-03
• Last updated: 2017-03-03

Regulatory

• FDA-regulated drug study