Sofosbuvir and velpatasvir with or without voxilaprevir in direct-acting antiviral-naïve chronic hepatitis C: patient-reported outcomes from POLARIS 2 and 3.

Background Chronic hepatitis C infection leads to impairment of patient-reported outcomes ( PROs). Treatment with direct-acting antiviral regimens results in short- and long-term improvement of these outcomes. Aim To assess PROs in patients treated with a newly developed direct-acting antiviral, a fixed-dose combination of sofosbuvir/velpatasvir ( SOF/ VEL) with/without voxilaprevir ( VOX). Methods The PRO data were collected from participants of POLARIS-2 and POLARIS-3 clinical trials ( DAA-naïve, all HCV genotypes). Participants self-administered SF-36v2, FACIT-F, CLDQ- HCV and WPAI: SHP instruments at baseline, during treatment, and in follow-up. Results Of 1160 patients, 611 received SOF/ VEL/ VOX and 549 received SOF/ VEL (52.8 ± 11.0 years, 55.9% male, 75.4% treatment-naïve, 33.9% cirrhotic). The sustained viral response at 12 weeks (SVR12) rates were 95%-98%. During treatment, improvements in most PRO scores were significant (all but one P < .01) and ranged from, on average, +2.3 to +15.0 points (on a 0-100 scale) by the end of treatment. These improvements were similar between SOF/ VEL/ VOX and SOF/ VEL arms (all P > .05). After treatment discontinuation, patients treated with both regimens achieved significant and clinically meaningful PRO gains (+2.7 to +16.7 by post-treatment week 12, +3.9 to +20.1 by post-treatment week 24; all but one P < .001). Multivariate analysis showed that depression, anxiety and cirrhosis were the most consistent independent predictors of PRO impairment while no association of PROs with the treatment regimen choice was found (all P > .05). Conclusions The pan-genotypic regimens with SOF/ VEL with or without VOX not only have excellent efficacy and safety, but also significantly positively impact patients' experience both during treatment and after achieving sustained virologic response in DAA-naïve patients with HCV. [ABSTRACT FROM AUTHOR]