Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV

Ain Shams University90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HCV

Interventions

Sofosbuvir-SimeprevirDRUG

-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-RibavirinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Evaluation at end-of-treatment response

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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