NVHR and PCORI

 
 
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Introduction

National Stakeholders

PCORI Funded Studies

National Patient and Stakeholder Dialogue

 

Introduction

In February of 2015, the Patient-Centered Outcomes Research Institute (PCORI) released a funding announcement seeking to fund clinical trials or observational studies that compared two or more alternatives for  addressing diagnosis, treatment, or management of hepatitis C infection. The studies could examine HCV treatment options, systems-level interventions, or interventions aimed at eliminating health or healthcare disparities.

This funding announcement would support two multi-year studies with respect to clinical management infection. There were four priority research sections and questions:

  • How new direct-acting antiviral (DAA) medication for HCV treatment compare in long-term virologic response and adverse effects?
  • What are the comparative benefits and harms of treating patients with HCV at the time of diagnosis versus waiting to treat only those who show early signs of liver progression?
  • Which HCV screening methods, confirmatory testing strategies, and clinical settings lead to the best rates of detection and linkage to treatment?
  • What is the comparative effectiveness of interventions to support the care of hard-to-treat patients with chronic hepatitis C infection (e.g., substance abusers, persons with complex medical regimens, the mentally ill), as measured by receipt of treatment, medication adherence, patient quality of life, and sustained viral response?

 

National Stakeholders

NVHR is proud to be a national stakeholder of both studies below that were funded by PCORI. As a broad range of communities have a stake in the healthcare system, PCORI utilizes stakeholder from a broad range of communities to guide research activities.

As a national stakeholder, NVHR is an integral part of the planning, conduct, and dissemination surrounding the PRIORITIZE and HERO studies. NVHR assists PCORI in the dissemination of research findings to the community.

PCORI Funded Studies

PRIORITIZE Study

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

Project Summary

In order to learn whether oral regimens for treating HCV work equally well under real-world conditions when delivered to a broad spectrum of patients, the proposed study will utilize a randomized pragmatic clinical trial design to compare the effectiveness of standard of care medications for HCV genotype 1 (Harvoni, Regimen A, and Viekira Pak, Regimen B) with the next all-oral therapy anticipated to be approved in early 2016 (Merck fixed-dose combination tablet, Regimen C). The study will collect and analyze comprehensive data on treatment effectiveness, drug side effects, post-treatment regression and regression of liver disease, and persistence of sustained virologic response (SVR).

To stay connected with the PRIORITIZE Study, visit their webpage here.

 

HERO Study

Patient-Centered Models of HCV Care for People Who Inject Drugs

Project Summary

People who inject drugs (PWID) have higher rates of hepatitis C virus (HCV) than other groups, but rarely access curative direct-acting antiviral (DAA) treatments due to cost or prescriber perceptions that PWID cannot adhere to medication or will become reinfected. This study explores two models for treating PWID for HCV: directly-observed treatment (DOT) and PWID treatment with the support of patient navigators (PN), public health workers who offer support and education to patients. The study will enroll 1,000 PWID with HCV to participate in eight sites around the country and randomize the patients into the PN or DOT groups. The analysis will focus on the efficacy of both treatments with regard to the proportion of patients who initiate treatment, adhere to medication, complete treatment, achieve SVR, and become reinfected.

To stay connected with the HERO study, visit their webpage here.

 

National Patient and Stakeholder Dialogue

In June of 2016, PCORI held a National Patient and Stakeholder Dialogue meeting in New York. This meeting brought national and patient stakeholder groups together with the researchers to kick off the studies, share information and ideas, and discuss the intricacies of treating people who inject drugs (PWID) for hepatitis C.

NVHR’s Program Director, Tina Broder, spoke on a panel at this national meeting. Broder and the other panelists discussed the public health and policy implications of the study, which compares two methods of providing hepatitis C treatment for people who inject drugs at eight sites around the country.

With regard to the HERO study, Broder said, "The findings from this study will help address stigma and remove barriers in the care cascade for people who inject drugs.”