Patient-reported outcomes 12 months after hepatitis C treatment with direct-acting antivirals: Results from the PROP UP study

Marina Serper, Donna M. Evon, Jipcy Amador, Paul W. Stewart, Souvik Sarkar, Anna S. Lok, Richard K. Sterling, Bryce B. Reeve, Carol E. Golin, K. Rajender Reddy, Joseph K. Lim, Nancy Reau, David R. Nelson, Adrian M. Di Bisceglie, Michael W. Fried

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
JournalLiver International
DOIs
StateAccepted/In press - 2021

Keywords

  • health-related quality of life
  • prospective cohort
  • symptoms
  • treatment
  • viral hepatitis

ASJC Scopus subject areas

  • Hepatology

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