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Viral eradication is required for sustained improvement of patient‐reported outcomes in patients with hepatitis C
Author(s) -
Younossi Zobair M.,
Stepanova Maria,
Reddy Rajender,
Manns Michael P.,
Bourliere Marc,
Gordon Stuart C.,
Schiff Eugene,
Tran Tram,
Younossi Issah,
Racila Andrei
Publication year - 2019
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.13900
Subject(s) - medicine , placebo , cirrhosis , gastroenterology , hepatitis c , pathology , alternative medicine
Background Clearance of chronic HCV infection improves quality of life and other patient‐reported outcomes ( PRO s). 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. PRO s 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 PRO s 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 PRO s, by treatment week 4; +2.0% to +8.3%, P < .05 for 14/26 PRO s by treatment week 12. Achieving SVR was associated with similar or greater PRO improvement: +2.5% to +11.9%, P < .05 for 24/26 PRO s, by SVR ‐12; +3.2% to +14.9%, P < .05 for 23/26 PRO s, 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.