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

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. [ABSTRACT FROM AUTHOR]