THE PRIORITIZE STUDY: A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Stakeholders

The proposed study will compare the effectiveness of the new standard of care medications for HCV Genotype 1 (Harvoni®-Regimen A and Viekira Pak™- Regimen B) to learn whether they work equally well under real world conditions. Given the anticipated approval of a third HCV treatment regimen with similar efficacy in trials (Merck all-oral regimen fixed-dose combination tablet, Regimen C) in mid-2016, we will develop an adaptive trial design to accommodate the comparison of the existing regimens to this one by adding a third arm. The Primary Aims are: 1) to compare effect on virologic cure (SVR) of regimen A vs regimen B vs regimen C; 2) to compare differences in drug side effects of regimen A vs regimen B vs regimen C; and 3) to evaluate differences in systemic symptoms after treatment with regimens A, B, C. The Secondary Aims are: to evaluate differences in post treatment progression of liver disease and persistence of viral cure after treatment with regimens A, B and C. Hypothesis 1: Treatment virologic cure rates and durability of cure will be equivalent between regimen A, regimen B and regimen C when used in real-world populations. Hypothesis 2: Measures of the number and severity of drug side effects will be higher for regimen B than regimen A or regimen C due to ribavirin use. Hypothesis 3: measures of liver disease progression, clinical outcomes, and PRO/QOL indicators will improve after achieving SVR.