Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV

Study Overview
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Brief Summary
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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.

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

Conditions
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HCV

Intervention / Treatment
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* Drug: Sofosbuvir-Simeprevir
* Drug: Sofosbuvir-Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic HCV infection with a positive HCV RNA level by PCR. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sofosbuvir-Simeprevir<br>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<br>* -Sofosbuvir-Simeprevir group included 50 patients who received sofosbuvir 400 mg orally once-daily plus simeprevir 150 mg orally once-daily for 12 weeks.<br>|
| Active Comparator: Sofosbuvir-Ribavirin<br>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<br>* -Sofosbuvir-Ribavirin group included 40 patients who received sofosbuvir 400 mg orally once-daily plus ribavirin orally twice-daily for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation at end-of-treatment response | undetectable HCV-RNA 12 weeks after the completion of therapy by a sensitive HCV-RNA assay | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV treatment