Last updated on October 2018

Sofosbuvir Plus Ravidasvir for the Treatment of HCV Chronic Infection

Brief description of study

This is a Phase II/III, multicenter, multi-country, trial to assess the efficacy, safety, tolerance, and pharmacokinetics of sofosbuvir plus ravidasvir for the treatment of HCV infection.

Detailed Study Description

The study will assess the efficacy and safety of SOF-RDV across all genotypes, among non-cirrhotic and cirrhotic with CTP class A, interferon/ribavirin nave or experienced, HCV mono-infected and HCV/HIV co-infected subjects.

It will also study the pharmacokinetics of RDV and, in HCV/HIV co-infected subjects, possible drug-drug interactions with antiretrovirals.

The treatment duration will be 12 weeks for subjects with no cirrhosis (Metavir F0 to F3) and 24 weeks for subjects with compensated cirrhosis (Metavir F4, CTP class A). After enrollment of the first 300 evaluable patients is complete, enrollment will pause while data is being accumulated and analyzed.

After review of interim results by the independent Data and Safety Monitoring Board (DSMB), and by the study Steering Committee, enrollment will resume.

Should modification of the study design be required upon interim analysis, decision will be taken by the study steering committee and the amended protocol or expanded protocol will be submitted to the Ethics Committee for approval.

Clinical Study Identifier: NCT02961426

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