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Abstract Details
Patient-Reported Outcomes 12 Months After Hepatitis C Treatment with Direct-Acting Antivirals: Results from the PROP UP Study
Liver Int. 2021 Jan 2. doi: 10.1111/liv.14781. Online ahead of print.
Marina Serper1, Donna M Evon2, Jipcy Amador3, Paul W Stewart3, Souvik Sarkar4, Anna S Lok5, Richard K Sterling6, Bryce B Reeve7, Carol E Golin8, K Rajender Reddy1, Joseph K Lim9, Nancy Reau10, David R Nelson11, Adrian M Di Bisceglie12, Michael W Fried2
Author information
1Division of Gastroenterology and Hepatology, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.
2Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, NC, United States.
3Department of Biostatistics, University of North Carolina, Chapel Hill, NC, United States.
4Division of Gastroenterology and Hepatology, Department of Medicine, University of California at Davis, Davis, CA, United States.
5Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, United States.
6Division of Gastroenterology, Hepatology & Nutrition, Department of Internal Medicine, Virginia Commonwealth University, Richmond, VA, United States.
7Department of Population Health Sciences, Duke University, Durham, NC, United States.
8Division of General Medicine and Clinical Epidemiology, Department of Medicine, Department of Health Behaviors, University of North Carolina, Chapel Hill, NC, United States.
9Digestive Diseases, Department of Internal Medicine, Yale University, New Haven, CT, United States.
10Department of Internal Medicine, Section of Hepatology, Rush University, Chicago, IL, United States.
11Division of Gastroenterology, Hepatology & Nutrition, Department of Medicine, University of Florida, Gainesville, FL, United States.
12Division of Gastroenterology and Hepatology, Department of Internal Medicine, Saint Louis University, St. Louis, MO, United States.
Abstract
Background and 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-center observational cohort study of 1,601 patients treated with DAAs at 11 U.S. gastroenterology/hepatology practices from 2015-2017. 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 greater than 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.