Background: Clearance of chronic HCV infection improves quality of life and other patient-reported outcomes (PROs). Lack of placebo-controlled data led to concerns about the extent of contribution of viral eradication to PRO improvement.
Aim: To assess PRO changes in HCV patients initially randomized to placebo treatment who received SOF/VEL/VOX in a deferred treatment substudy.
Methods: HCV-infected direct-acting antivirals-experienced patients who received placebo treatment in POLARIS-1 subsequently received SOF/VEL/VOX (400/100/100 mg) daily for 12 weeks. PROs were prospectively collected using SF-36v2, CLDQ-HCV, FACIT-F, WPAI:SHP.
Results: Of 147 patients treated, most were male (79%), white (82%), 33% had cirrhosis, 99% had HCV genotype 1 with SVR-12 of 97%. During treatment with placebo, there were no significant changes in any PROs from patients' own baseline (all P > .05) except for the Worry domain of CLDQ-HCV. However, soon after initiation of treatment with SOF/VEL/VOX, significant PRO improvements were noted: +2.4% to +8.1% of a PRO range size, P < .05 for 6 of the 26 studied PROs, by treatment week 4; +2.0% to +8.3%, P < .05 for 14/26 PROs by treatment week 12. Achieving SVR was associated with similar or greater PRO improvement: +2.5% to +11.9%, P < .05 for 24/26 PROs, by SVR-12; +3.2% to +14.9%, P < .05 for 23/26 PROs, by SVR-24. In multivariate regression analysis, being viraemic was associated with PRO impairment: beta from -2.4% to -8.5%, P < .05 for all but one PRO.
Conclusion: Treatment with SOF/VEL/VOX for 12 weeks led to significant and sustainable improvement in patient-reported outcomes in patients who had previously failed another direct-acting antiviral regimen.
Keywords: emotional health; fatigue; health-related quality of life; vitality; work productivity.
© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.