Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: HCV

Treatments: Drug: Sofosbuvir-Ribavirin; Drug: Sofosbuvir-Simeprevir

Study type: Interventional

Funder types: Other

Identifiers

NCT03069001

958

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

Sofosbuvir-Simeprevir

Active Comparator group

Description:

* 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.

Treatment:

Drug: Sofosbuvir-Simeprevir

Sofosbuvir-Ribavirin

Active Comparator group

Description:

* 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.

Treatment:

Drug: Sofosbuvir-Ribavirin