During Phase 1, the PRIORITIZE study compared the effectiveness of 3 approved HCV treatment regimens (HARVONI®, Viekira Pak™, Zepatier™) to learn whether they work equally well under real world conditions. During Phase 2 of this study, randomization was revised from a 3-arm trial to a 2-arm trial (HARVONI® and Zepatier™). Using methods developed in HCV-TARGET to collect clinical data on safety and effectiveness, patients receiving HCV therapy in community and academic clinics were offered the opportunity to consent to be randomly assigned to Regimen HARVONI®, Zepatier™ or Viekira Pak™ (Phase 1 only), and then observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management were assumed by usual care conditions, in keeping with pragmatic design principles.
Overall, the PRIORITIZE study was designed to collect and analyze comprehensive data to address the multi-faceted outcomes and measures that HCV patients and stakeholders identified as being most important when making HCV treatment decisions.