Project Summary
Background: Newer, more effective medication regimens for chronic hepatitis C viral (HCV) infection are approved. For the first time, patients and providers will have more than one treatment option from which to choose. Deciding which treatment to choose may be challenging for patients, as regimens may be relatively similar on cure rates but may differ on other harms and benefits that matter to patients. Data collected from clinical drug trials do not provide all the answers, nor does the data represent the broad range of patients who will be treated in real-world clinical practice. Meanwhile, HCV-TARGET is the largest international research network and clinical registry of patients undergoing treatment, and provides a unique opportunity to evaluate patient-reported outcomes in a diverse spectrum of patients treated in real-world clinical settings.
Methods: PROP up TARGET will be a prospective, observational cohort study of 1,600 patients infected with genotype 1 HCV and who initiate treatment at eight US liver centers. A HCV patient engagement group (HCV-PEG) and data derived from 45 patient interviews identified the top-priority information that affects patient decision making. Based on these informational needs of HCV patients, we will ask study participants to complete surveys to collect information on: (1) harms that may occur during treatment (side effects, poor functioning, out-of-pocket costs, difficulty with adherence); (2) benefits of treatment 3 months after it ends (do preexisting HCV symptoms and functioning improve?); and (3) longer-term toxicities and side effects that may occur up to 1 year after treatment ends. Participants will complete surveys at 5 time points: before treatment, twice during treatment, and 3 and 12 months after treatment. Our HCV-PEG members took, on average, 13 minutes to complete the surveys. Participants can answer surveys via three methods based on their preference: from their home-based computers, from a phone interview with our call center, or with the research coordinator at regularly scheduled visits with the liver doctor. All data will be entered into a web-based secure data management system. Our HCV-PEG indicated that it was reasonable to pay participants $25 for the first three assessments and $40 for the last two assessments.
Patient Engagement: Our research team includes patient partners (seven members of the HCV-PEG) and a patient advocacy organization; both will represent the patients’ voices on the study steering committee.
PROP up TARGET is committed to collecting information to help patients and providers make more-informed treatment decisions. This study to compare two new all-pill treatments is the first head-to-head study of short-term and longer-term outcomes that were selected by patients with HCV, and will matter most to patients making future decisions about HCV treatment.
Evon DM, Golin CE, Stewart P, et al., Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment, Contemporary Clinical Trials (March 2017).
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