Long-Term Benefits of Sustained Virologic Response for Patient-Reported Outcomes in Patients with Chronic HCV Infection

Abstract Background & Aims Patients with hepatitis C virus (HCV) infections who achieve a sustained virologic response (SVR) to treatment have improved patient-reported outcomes (PROs). We compared post-treatment PRO scores between patients with chronic HCV infection who did and did not achieve an SVR to treatment. Methods Patients who completed treatment in clinical trials were enrolled in 2 registries, depending on the treatment outcome (#NCT01457755, #NCT01457768), from 2016–2017 in 17 countries in North America, Europe, and Asia-Pacific region. PRO scores (a 0–100 scale) were collected at pre-treatment (baseline); the last day of treatment; the post-treatment week 12 follow-up visit (in patients with SVR only); the registry baseline; and on registry weeks 12, 24, 36, 48, and 96 (the non-SVR registry) or every 24 weeks until week 96 (SVR registry), using the short form-36 (SF-36) instrument. Results Our analysis included 4234 patients with an SVR and 242 without an SVR from whom pre-treatment PRO data were available (mean age, 54±10 years; 63% male; 65% enrolled in the United States; 17% with cirrhosis; 12% with HIV coinfection). Upon registry enrollment, patients with an SVR had significant increases in all PRO scores compared with pre-treatment baseline levels (all P Conclusions In a follow-up analysis of participants in clinical trials, we found that those with an SVR to treatment for HCV infection had significant increases in well-being, based on PRO scores. Patients without an SVR had decreasing PRO scores over the follow-up period.