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Patient‐Reported Outcomes of Elderly Adults with Chronic Hepatitis C Treated with Interferon‐ and Ribavirin‐Free Regimens
Author(s) -
Younossi Zobair M.,
Stepanova Maria,
Nader Fatema,
Henry Linda
Publication year - 2016
Publication title -
journal of the american geriatrics society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.992
H-Index - 232
eISSN - 1532-5415
pISSN - 0002-8614
DOI - 10.1111/jgs.13928
Subject(s) - medicine , sofosbuvir , regimen , ribavirin , ledipasvir , hepatitis c , pegylated interferon , chronic hepatitis , clinical trial , gastroenterology , immunology , virus
The purpose of the study was to assess the effect of different treatment regimens for chronic hepatitis C on patient‐reported outcomes ( PRO s) of individuals aged 65 and older with chronic hepatitis C. PRO data from eight multinational multicenter Phase 2 and 3 clinical trials were included. Of 3,120 participants in these clinical trials, 229 were aged 65 and older (67.8 ± 3.2, 57% male, 75% treatment‐naïve, 22% cirrhotic), and 90 of those received ledipasvir plus sofosbuvir ( LDV + SOF ), 119 received SOF plus ribavirin ( SOF + RBV ), and 20 received pegylated IFN , SOF , and RBV ( IFN + SOF + RBV ). Participants aged 65 and older had slightly more pretreatment PRO impairment in their physical functioning than younger individuals (−3.1% on a normalized 0–100% PRO scale, P < .001). Despite this, these participants experienced significant PRO improvement during treatment with IFN ‐free RBV ‐free regimens (up to +8.0%, P < .001), similar to improvements in younger participants. In contrast, participants aged 65 and older experienced substantial decline in PRO s while receiving IFN ‐ or RBV ‐containing regimens (up to −18.9% in IFN + SOF + RBV , −10.4% in IFN ‐free SOF + RBV , P < .001), and some were greater than in the younger group. Nevertheless, after achieving sustained viral clearance at Posttreatment Week 12, PRO s in participants aged 65 and older improved regardless of the regimen (up to +10.4%, P < .001). In multivariate analysis of the cohort aged 65 and older, the use of IFN and RBV was consistently associated with PRO impairment during treatment. The use of an IFN ‐ and RBV ‐free anti‐ HCV regimen in older adults with hepatitis C results in significant improvement of PRO s.