Patient‐Reported Outcomes of Elderly Adults with Chronic Hepatitis C Treated with Interferon‐ and Ribavirin‐Free Regimens

Abstract

The purpose of the study was to assess the effect of different treatment regimens for chronic hepatitis C on patient-reported outcomes (PROs) 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 PROs 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, PROs 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 PROs.

The effect of interferon‐free regimens on health‐related quality of life in East Asian patients with chronic hepatitis C

“…In contrast, there was only a moderate and rapidly reversible decline in patients who received the IFN‐free regimen with SOF + RBV. These data clearly document the superiority of the IFN‐free regimen in East Asian patients with HCV infection, and are similar to previous reports . Furthermore, in this context, the belief that IFN‐containing regimens can be well tolerated by East Asian patients with HCV is not supported by HRQL data.…”

“…Since evaluation of depression and anxiety in Asian countries is a known issue, it is unclear whether these conditions are indeed rarely seen in those population, including patients with HCV, or are under‐reported due to clinical or cultural factors. Prior to the initiation of treatment, we also noted that independent predictors of HRQL impairment in East Asian patients were similar to those that have been previously reported for other patients with HCV …”

“…Despite these major advances in the treatment of chronic HCV infection, DAAs are not universally available in all East Asian countries . In this context, it is important to note that the DAA‐based regimens have been associated with not only high efficacy and better tolerability, but also with significant improvement of HRQL and other PROs . In contrast, IFN‐containing regimens cause significant impairment of HRQL and PROs .…”

Hepatitis C infection: A multi-faceted systemic disease with clinical, patient reported and economic consequences

“…In summary, the current data suggest that significant PRO gains occur with the new DAA treatment regimens regardless of the patient population (coinfected, advanced fibrosis, retreatments, and treatment failures) with the largest gains noted in those patients who obtain SVR [84][85][86][87][88][89][90][91][92][93][94][95][96][97][98][99][100][101][102]. Therefore, regardless of the treatment needed, SVR should be the goal, not only to improve clinical outcomes, but also to improve patients' experience as documented by improving PRO scores.…”

“…In contrast, the use of the new interferon-and ribavirin-free all oral regimens for HCV treatment have resulted in significant improvement in patients' HRQOL scores as early as 2 weeks into the treatment, especially in those domains most affected by the hepatitis C virus [physical functioning, work productivity (presenteeism), social functioning, activity]. In fact, by the end of treatment with the DAA's many of the significantly improved scores closely approximated or surpassed the HRQOL scores of the general population without HCV [84][85][86][87][88][89][90][91][92][93][94][95][96][97][98][99][100][101]. These PRO gains have also been observed in patients with both early and advanced fibrosis [90,98].…”