@article{cfcd42580aec468d812d19cc55edc51a,
title = "Patient-reported outcomes 12 months after hepatitis C treatment with direct-acting antivirals: Results from the PROP UP study",
abstract = "Background & Aims: The long-term impact of hepatitis C virus (HCV) therapy with all-oral direct-acting antivirals (DAAs) on patient-reported outcomes (PROs) has not been well-described. We characterized changes in PROs from pre-treatment to 12 months post-treatment in a real-world cohort. Methods: PROP UP was a multi-centre observational cohort study of 1601 patients treated with DAAs at 11 US gastroenterology/hepatology practices from 2015 to 2017. PROs were evaluated pre-treatment (T1) and 12 months post-treatment (T5). A minimally important change (MIC) threshold was prespecified as >5% change in PRO scores from T1 to T5. Multivariable analyses identified predictors of change. Results: Three-quarters of patients were 55 or older; 45% were female, 60% were white, 33% were black, nearly half had cirrhosis. The most commonly-prescribed DAA regimens were sofosbuvir-based (83%) and grazoprevir/elbasvir (11%). Study retention was >95%. On average, small improvements were observed at 3 months post-treatment in all PROs and sustained at 12 months post-treatment among patients with sustained virologic response (SVR). Clinically meaningful improvements were achieved in fatigue (mean change score: −3.7 [−4.2, −3.1]), sleep (mean change score: −3.1 [−3.7, −2.5]), abdominal pain (mean change score: −2.6 [−3.3, −1.9]) and functional well-being (mean change score: −7.0 [−6.0, −8.0]). Symptom improvements were generally not sustained with no SVR (n = 52). Patients with cirrhosis and MELD ≥12 had the greatest improvements in functional well-being (−12.9 [−17.6, −8.1]). Conclusions: The improvements in patient-reported outcomes reported by patients who achieved SVR following HCV DAA therapy were durable at 12 months post-treatment.",
keywords = "health-related quality of life, prospective cohort, symptoms, treatment, viral hepatitis",
author = "Marina Serper and Evon, {Donna M.} and Jipcy Amador and Stewart, {Paul W.} and Souvik Sarkar and Lok, {Anna S.} and Sterling, {Richard K.} and Reeve, {Bryce B.} and Golin, {Carol E.} and {Rajender Reddy}, K. and Lim, {Joseph K.} and Nancy Reau and Nelson, {David R.} and {Di Bisceglie}, {Adrian M.} and Fried, {Michael W.}",
note = "Funding Information: Donna M. Evon receives research funding from Gilead and Merck. Michael Fried has received research funding from and served as a consultant for AbbVie, BMS, Gilead, and Merck, and TARGET PharmaSolutions. Stock in TARGET PharmaSolutions is held in an independently managed trust. Anna S. Lok has received research support from BMS, Gilead, TARGET PharmaSolutions, AbbVie (ended in 2016), and Merck (ended in 2016); and served as an advisor for Gilead (interrupted between 1/2016‐12/2018). Richard K. Sterling has received research support from AbbVie, BMS, Gilead, Merck, and Roche and served as a consultant for Merck, Bayer, Salix, AbbVie, Gilead, Jansen, ViiV, Baxter, and Pfizer. Joseph K. Lim has received research support (paid to Yale University) and served as a consultant for Bristol‐Myers Squibb and Gilead. Nancy Reau has received research funding (paid to Rush) from AbbVie and Intercept and has served as a consultant for Merck, AbbVie, Abbott, and Gilead. Souvik Sarkar served on a Gilead and AbbVie Advisory Board and received grant support from Gilead through UCSF (paid to UC Davis). David R. Nelson has received research grant support from AbbVie, BMS, Gilead, Janssen, and Merck and owns stock in TARGET PharmaSolutions. K. Rajender Reddy is an Ad‐Hoc Advisor to Gilead, BMS, Janssen, Merck, AbbVie, Shionogi, and Dova and has received research support from Gilead, BMS, Janssen, Merck, AbbVie, Intercept, Mallinckrodt, and Conatus (paid to the University of Pennsylvania). Adrian M. Di Bisceglie has received research support from AbbVie, BMS and Gilead and has served on advisory boards for AbbVie, BMS, Gilead and Merck. He serves as Chair of the Steering Committee for TARGET HCC, a registry study funded by TARGET PharmaSolutions. Paul Stewart has served as a consultant to TARGET PharmaSolutions. Jipcy Amador served as a biostatistics intern at TARGET PharmaSolutions in 2017. Carol E. Golin, Bryce Reeve, and Marina Serper declare that they have no conflict of interests to disclose. ",
year = "2021",
doi = "10.1111/liv.14781",
language = "English (US)",
journal = "Liver International",
issn = "1478-3223",
publisher = "Wiley-Blackwell",
}