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

Project: Research project

Description

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.
StatusActive
Effective start/end date3/1/162/28/21

Funding

  • University of Florida (UFDSP00011097//HPC-1503-27891)
  • Patient-Centered Outcomes Research Institute (UFDSP00011097//HPC-1503-27891)

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Hepatitis C
Decision Making
Drug-Related Side Effects and Adverse Reactions
Liver Diseases
Therapeutics
Ribavirin
Standard of Care
Regimen B
Tablets
Disease Progression
Genotype
Population