Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV

NCT03069001 | Completed Phase 4 FDA Drug

• 1 other identifier: 958
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HCV

Keywords

HCV treatment

Outcome Measures

Primary Outcomes (1)

• Evaluation at end-of-treatment response

  undetectable HCV-RNA 12 weeks after the completion of therapy by a sensitive HCV-RNA assay

  12 weeks

Study Arms (2)

Sofosbuvir-Simeprevir

ACTIVE COMPARATOR

* 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.

Drug: Sofosbuvir-Simeprevir

Sofosbuvir-Ribavirin

ACTIVE COMPARATOR

* 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.

Drug: Sofosbuvir-Ribavirin

Interventions

Sofosbuvir-Simeprevir DRUG

-Sofosbuvir-Simeprevir group included 50 patients who received sofosbuvir 400 mg orally once-daily plus simeprevir 150 mg orally once-daily for 12 weeks.

Sofosbuvir-Simeprevir

Sofosbuvir-Ribavirin DRUG

-Sofosbuvir-Ribavirin group included 40 patients who received sofosbuvir 400 mg orally once-daily plus ribavirin orally twice-daily for 24 weeks.

Sofosbuvir-Ribavirin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

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: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 3, 2017
• Study Start: June 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-02