Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV

Phase 4

Completed

• Conditions: HCV
• Interventions: Drug: Sofosbuvir-Simeprevir; Drug: Sofosbuvir-Ribavirin

• Registration Number: NCT03069001
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-02
• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-02-27
• Last Update Submitted: 2017-02-27
• Study First Posted: 2017-03-03
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with chronic HCV infection with a positive HCV RNA level by PCR.

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Exclusion Criteria

• Total bilirubin > 2 mg/dl.
• serum albumin < 2.8 g/dl.
• INR > 1.7.
• platelet count < 50000/mm3.
• serum creatinine > 2.5 mg/dl.
• patients presented by ascites or hepatic encephalopathy.
• patients with evidence of other causes of liver diseases, including hepatitis A, hepatitis B, autoimmune hepatitis, alcoholic liver disease, drug-induced hepatitis, haemochromatosis, Wilson disease or alpha-1 antitrypsin deficiency.
• patients with any advanced systemic disease.
• pregnancy or inability to use effective contraception in females.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sofosbuvir-Simeprevir	Sofosbuvir-Simeprevir	* Sofosbuvir 400 mg orally once-daily. * Simeprevir 150 mg orally once-daily. * Group A included 50 patients who received sofosbuvir 400 mg orally once-daily plus simeprevir 150 mg orally once-daily for 12 weeks.
Sofosbuvir-Ribavirin	Sofosbuvir-Ribavirin	* Sofosbuvir 400 mg orally once-daily. * Ribavirin orally twice-daily (according to body weight: 1000 mg daily in patients with a body weight of \<75 kg and 1200 mg daily in patients with a body weight of ≥75 kg). * Group B included 40 patients who received sofosbuvir 400 mg orally once-daily plus ribavirin orally twice-daily for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Evaluation at end-of-treatment response	12 weeks	undetectable HCV-RNA 12 weeks after the completion of therapy by a sensitive HCV-RNA assay