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?
HCV causes a potentially long-term infection that can lead to serious liver damage, liver failure, and even death. About 3 to 4 million people in the United States have HCV. Several oral medicines are available to treat HCV. However, some patient groups haven’t been included in HCV treatment research studies often enough to know which treatments work best for them.
This study is enrolling patients from a network of 45 medical centers with diverse populations. The study is comparing how well two combinations of oral medicines work to cure HCV infection and help patients avoid side effects. The researchers are enrolling enough patients from the medical centers so that they can study whether different drugs work better for people with different backgrounds and experiences.
Who can this research help?
The results of this research may help patient groups that have not often been included in HCV treatment research studies, such as African Americans, adults over age 65, people with mental illness, those with multiple medical conditions, and people who have a history of drug or alcohol use. Doctors whose patients have HCV can also use information from this study in decisions about HCV treatment.
What is the research team doing?
All patients in the study have a type of HCV called genotype 1. The research team is dividing patients into two groups. Each group includes people with different subtypes of HCV and different levels of liver function. The research team is assigning patients by chance to one of the two combinations of HCV medicines.
The research team is collecting information about the patients from their medical records and from medical test results. The team is also asking patients to complete surveys.
The research team is using the information they collect to see how well each combination of medicines works at eliminating the virus. Researchers are also looking at the side effects of these medicines. The team is also looking at how well patients follow the directions for taking the medicines, whether their symptoms improve, and how well they can do their normal daily activities. The team is also looking at how healthy patients’ livers are after HCV treatment and whether the virus returns within three years.
The research team is working with patients, patient advocacy groups, and experts in HCV to plan the study, conduct it, and look at its results. Patients are also helping the research team create materials that will be helpful in attracting diverse patient groups to enroll in the study.
Research methods at a glance
|Study Design||Pragmatic randomized clinical trial|
|Population||Patients infected with HCV genotype 1 at 45 medical centers|
Absence of HCV at 12 weeks, 24 weeks, and 3 years following treatment
|12-week follow-up after completing HCV treatment|