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.

Impact of direct-acting antiviral treatment of hepatitis C on the quality of life of adults in Ukraine

“…The results we observed in this cohort in Ukraine were similar to or of greater magnitude than those reported from other settings [ 6 , 14 – 16 ]. In a Japanese cohort, the only domain of the MOS SF-36 that was found to be significantly improved was general health perception, with an improvement of 3.81 that persisted at 3 years after treatment with DAA [ 6 ].…”

Reaching people receiving opioid agonist therapy at community pharmacies with hepatitis C virus: an international randomised controlled trial

“…Taken together, this reinforces the view that HCV diagnosis can negatively affect QoL for PWID. Given that, the lack of change from baseline to follow‐up was somewhat unexpected, as previous research has shown positive improvements in QoL indicators both for non‐PWID, and for PWID in receipt of OAT following HCV treatment with DAAs 39–42 . Our findings, taken together with the wider evidence, suggest further work is required to uncover mechanisms beyond therapeutic resolution of HCV to improve health‐related QoL for PWID infected with HCV.…”

Impact of direct-acting antiviral treatment of hepatitis C on the quality of life of adults in Ukraine

“…The results we observed in this cohort in Ukraine were similar to or of greater magnitude than those reported from other settings. 5,13–15 In a Japanese cohort, the only domain of the MOS SF-36 that was found to be significantly improved was general health perception, with an improvement of 3.81 that persisted at 3 years after treatment with DAA. 5 Younossi et al found similarly that statistically significant, modest improvements in reported QOL were sustained as long as 2 years after SVR was achieved in U.S. patients.…”