HCV
Conditions
Keywords
HCV treatment
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.
Interventions
DRUGSofosbuvir-Simeprevir
-Sofosbuvir-Simeprevir group included 50 patients who received sofosbuvir 400 mg orally once-daily plus simeprevir 150 mg orally once-daily for 12 weeks.
DRUGSofosbuvir-Ribavirin
-Sofosbuvir-Ribavirin group included 40 patients who received sofosbuvir 400 mg orally once-daily plus ribavirin orally twice-daily for 24 weeks.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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 \> 1.7. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation at end-of-treatment response | 12 weeks | undetectable HCV-RNA 12 weeks after the completion of therapy by a sensitive HCV-RNA assay |
Outcome results
None listed