368 Improvement of Patient-Reported Outcomes in Older Patients With Chronic Hepatitis C (CH-C) Treated With Interferon- and Ribavirin-Free Sofosbuvir (SOF)-Containing Regimens

BACKGROUND: Baby boomers, born in 1945-1965, account for 75% of all HCV infections in the U.S. This cohort will become the majority of treatment candidates for the coming decades. Available IFNand RBV-free regimens can improve PROs during and after treatment in patients with CH-C. Whether similar PRO improvements could be observed in older CHC patients is unknown. AIM: To assess the impact of RBV-free vs. RBV-containing SOFbased regimens on PROs of CH-C patients of 65 years of age or older. METHODS: The PRO data from eight multicenter multinational phase 3 clinical trials of sofosbuvir (SOF)based regimens with and without ledipasvir (LDV) or RBV (POSITRON, FISSION, FUSION, VALENCE, PHOTON-1, ION-1, ION-2, and ION-3) were used. While blinded to their HCV RNA results, patients completed 4 validated PRO questionnaires [Short Form-36 (SF-36), Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Work Productivity and Activity Index: Specific Health Problem (WPAI:SHP)] which were administered at baseline, during treatment, and post-treatment. RESULTS: A total of 3,016 CH-C patients were treated with interferon-free SOF-containing regimens. Of these, 217 patients were older than 65 years (68.0±3.2 years old, 58% male, 73% treatment-naive, 21% cirrhotic). Of the 65+ cohort, 90 received SOF/ LDV (100% genotype 1, SVR-12: 96.7%), 62 received SOF/LDV+RBV (100% genotype 1, SVR-12: 96.8%), and 65 received SOF+RBV (100% genotype 2/3, SVR-12: 83.1%). In comparison to younger than 65, the 65+ CH-C cohort had some pre-treatment PRO impairments in physical functioning-related items (up to -3.2% of maximum of 100%, p<0.001). Despite this, 65+ CH-C patients showed significant improvements of their PROs during treatment with RBV-free regimens, which were similar to those observed in younger CH-C patients (improvement up to +7.7%, p<0.0001) (Figure 1). In contrast, the 65+ cohort experienced a decline in their PRO scores while receiving RBV-containing regimens (up to -10.0%, p<0.0001) (Figure 1). Several PRO declines in the 65+ cohort were greater than in the cohort younger than 65 (by 3.2%-5.0%, p<0.02). Nevertheless, after achieving SVR-12, PROs in 65+ CH-C patients improved regardless of the regimen (up to +10.0%, p<0.0001). In multivariate analysis of the 65+ CH-C patients, RBV was consistently associated with PRO impairment during treatment (beta from -4.7% to -13.4%, p<0.05). Other significant (p<0.05) predictors of PRO impairment included previously reported factors (depression, anxiety, cirrhosis). CONCLUSIONS: The use of IFNand RBV-free LDV/SOF regimens leads to PRO improvement in 65+ patients with CH-C. Since this cohort will comprise a large proportion of CH-C patients, it is important that they benefit from not only a high cure rate but also from better PRO experience.