NCT04382339

Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4

Effectiveness of Sofosbuvir/Pegylated-interferon Plus Ribavirin in Treatment of Hepatitis C Virus Genotype 4 Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants

Detailed description

Between March 2015 and November 2015, 99 participants (59 naïve and 40 experienced) infected with HCV GT4 were enrolled in the study. Eligible participants received daily oral 400 mg SOF ( (Sovaldi, Gilead Sciences, Inc., USA), RBV (Copegus, Roche, Europe) based on body weight: \< 75 kg, 1000 mg; ≥75 kg, 1200 mg), the dose modified according to participants tolerability, plus 180 μg PegINFα-2 once weekly for 12 weeks. Experienced participants included participants with a prior relapse or a null response to PegINF/RBV therapy.

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	SOF/RBV/PegINFα-2	SOF: block the hepatitis C NS5B protein. RBV: a nucleoside inhibitor PegINFα-2: chemically modified form of the standard interferon that treats hepatitis C

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2020-05-11
• Last updated: 2020-05-11