Project Summary

PCORI has identified hepatitis C as an important research topic. Patients, clinicians, and others want to learn: What treatments work best for hard-to-treat patients with hepatitis C? To help answer this question, PCORI launched a funding initiative in 2015 on Clinical Management of Hepatitis C Infection. This research project is one of the studies PCORI awarded as part of this program.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Hepatitis C is a virus that causes damage and swelling in the liver. About 3 to 4 million people in the United States have chronic hepatitis C. The most common way to get hepatitis C is through sharing needles to inject illegal drugs. People who inject drugs have higher rates of hepatitis C infection than other groups. Recent surveys show that almost half of active injection-drug users who are 18 to 30 years old have hepatitis C. Up to 90% of patients in treatment programs for opioid addiction have hepatitis C.

Doctors treat hepatitis C with medicines called direct-acting antiviral agents. These medicines attack the virus and can cure the disease in most cases. However, people who inject drugs rarely get these treatments. One reason is that the treatments are expensive, and some insurance companies may not cover their cost. Also, doctors may not want to prescribe these treatments to people who inject drugs, because they worry that injection drug users may not take the medicine properly. Doctors may also worry that these patients could get infected with hepatitis C again.

This study compares two ways to provide treatment for people with hepatitis C who inject drugs:

  • Patients take medicine in front of a clinic staff member. This is called directly observed treatment. In directly observed treatment, patients may instead use a smartphone app to take videos of themselves taking medicine.
  • Patient navigators—trained staff who provide support to patients—educate patients to help them overcome barriers to taking their medicine.

Who can this research help?

This research can help care providers, payers and policy makers choose how to treat hepatitis C.

What is the research team doing?

At eight sites around the country, the research team is enrolling up to 750 people with hepatitis C who inject drugs. Patients in the study are 18 to 70 years old. Patients are assigned by chance to one of two groups: one group takes their medicine in front of a staff member in person or by video, and the other group gets help from a patient navigator. The research team wants to know how many people in each group

  • Start their treatment
  • Take at least 80 percent of their medicine
  • Finish their treatment
  • Become resistant to the medicine
  • Become infected with hepatitis C again

The research team is looking at whether issues such as homelessness, mental illness, and lack of knowledge about hepatitis C affect treatment outcomes. The research team is interviewing patients to learn about their experiences taking the medicine. The researchers are also interviewing clinic leaders and staff, patient navigators, and research staff to see what they think about the program.

The Centers for Disease Control and Prevention is leading a group of organizations with an interest in hepatitis C and its treatment that are providing advice and resources to the project. The group also includes

  • State and local government officials (New York City Department of Health and Mental Hygiene, New York State Department of Health, state Medicaid directors from West Virginia, New York, and Washington)
  • Patient and drug treatment groups (American Association for the Treatment of Opioid Dependence, Harm Reduction Coalition, Hepatitis C Mentor and Support Group, Hepatitis Education Project, National AIDS Treatment Advocacy Project, National Alliance for Medication Assisted Recovery, National Viral Hepatitis Roundtable, Project Inform, Treatment Action Group)
  • Drug abuse treatment groups (Medication-Assisted Recovery Services)
  • Insurers (Healthfirst)
  • Laboratories (Monogram Biosciences, OraSure Technologies, Quest Diagnostics)
  • Pharmaceutical companies (Gilead Sciences)

Research methods at a glance

Design Element Description
Study Design Randomized controlled trial
Population Adults 18 to 70 years old who have hepatitis C, are actively injecting drugs, and have not been previously treated with direct-acting antiviral medications
Interventions/
Comparators
  • Patient navigation
  • Directly observed treatment
Outcomes

Primary: hepatitis C viral load not detected 12 weeks after treatment is complete

Secondary: hepatitis C treatment initiation, treatment adherence, treatment completion, and becoming infected with hepatitis C again

Timeframe 12-week follow-up for primary outcome

Journal Articles

Project Information

Alain Litwin, MD, MPH, MS
Clemson University^
$15,593,885

Key Dates

75 months
September 2015
February 2023
2015

Study Registration Information

^Montefiore Medical Center was the orginal organization associated with this project.

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These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them.

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PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders.

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PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care.

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Last updated: September 27, 2021