NCT03069001CompletedPhase 4
Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Egyptian Patients With HCV
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 90
- Primary Endpoint
- Evaluation at end-of-treatment response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •platelet count < 50000/mm
- •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.
Arms & Interventions
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.
Intervention: Sofosbuvir-Simeprevir (Drug)
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.
Intervention: Sofosbuvir-Ribavirin (Drug)
Outcomes
Primary Outcomes
Evaluation at end-of-treatment response
Time Frame: 12 weeks
undetectable HCV-RNA 12 weeks after the completion of therapy by a sensitive HCV-RNA assay
Secondary Outcomes
No secondary outcomes reported
Investigators
Sara Abdelhakam
Assistant Professor
Ain Shams University
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