Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral)
HCV treatment regimens to learn whether they worked equally well under real-world conditions.
Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization
to just 2 FDA approved DAA regimens. Patients receiving HCV therapy in community and academic
clinics were offered the opportunity to consent to be randomly assigned to one of three
(phase 1) or one of two (phase 2) regimens and observed for outcomes. Once randomized, all
medical care, laboratory testing, and any disease or side effect management were assumed by
usual care conditions, and patient-reported outcomes were collected outside clinic in keeping
with pragmatic design principles.
Phase:
Phase 4
Details
Lead Sponsor:
University of Florida
Collaborators:
AbbVie Merck Sharp & Dohme Corp. Patient-Centered Outcomes Research Institute