NCT02156570

DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral)

An Interferon Sparing Strategy of Sofosbuvir Plus Ribavirin for the Treatment of Recently Acquired Hepatitis C Infection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to examine whether patients who have acute or early chronic hepatitis C virus (HCV) infection can be treated effectively and safely with an interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir) with one of the standard treatments for chronic hepatitis C (ribavirin). In particular, this study will investigate whether treatment of acute or early chronic HCV can be shortened. The study will assess efficacy by looking at the proportion of people who clear the virus (have no virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after treatment. The hypothesis is that short course (6 weeks) dual therapy using sofosbuvir and RBV will result in successful virological eradication in the majority (≥80%) of subjects treated for recently acquired HCV.

Detailed description

To evaluate the efficacy, safety and acceptability of an interferon-sparing strategy with sofosbuvir and ribavirin for the treatment of recently acquired HCV infection. An open label single arm multicentre study Treatment of participants: Sofosbuvir 400mg daily with weight based ribavirin (1000mg \<75 kg, 1200mg \>/= 75kg) Duration of treatment will be 6 weeks for all subjects followed by 52 weeks of observational follow-up Total study duration = 58 weeks Primary endpoint: SVR 12

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Sofosbuvir and ribavirin	Sofosbuvir 400mg daily plus weight-based dosing ribavirin (1000mg \<75kg, 1200mg \>/= 75 kg) Treatment will be for 6 weeks in all participants.

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-08-01
• Completion: 2017-12-01
• First posted: 2014-06-05
• Last updated: 2018-09-21

Locations

5 sites across 2 countries: Australia, New Zealand