Research ArticlePatient-reported outcomes assessment in chronic hepatitis C treated with sofosbuvir and ribavirin: The VALENCE study

Background & AimInterferon (IFN) negatively impacts patients' well-being and patient-reported outcomes (PROs). Our aim was to assess PROs during treatment with an IFN-free regimen [sofosbuvir (SOF) + ribavirin (RBV)].MethodsFour PRO questionnaires [Short Form-36 (SF-36), Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity Index: Specific Health Problem (WPAI:SHP)] were administered at baseline, end-of-treatment and post-treatment to 334 HCV genotype 2 and 3 patients (naïve or treatment-experienced) enrolled in the VALENCE study. Of these, 250 genotype 3 patients were treated for 24 weeks while 73 genotype 2 and 11 genotype 3 patients received 12 weeks of treatment.ResultsBaseline PRO scores were similar between the two arms of the study. Throughout and after treatment, patients receiving 12 or 24 weeks had similar FACIT-F, CLDQ-HCV, SF-36 and WPAI:SHP scores (all p >0.05). Compared to their own baseline scores, patients receiving SOF + RBV experienced modest declines in some aspects of SF-36, CLDQ-HCV, fatigue and WPAI:SHP scores (p = 0.04 to <0.0001). By follow-up week 12, all PRO scores returned to the pre-treatment levels (p >0.05). In patients achieving SVR-12 (regardless of the regimen), significant improvements were noted in general health (p = 0.0004), CLDQ-HCV (p <0.0001), fatigue (p = 0.005), emotional well-being (p <0.0001) and physical component summary score of SF-36 (p = 0.0022). In multivariate analysis, baseline depression, fatigue, insomnia, cirrhosis, and treatment-related adverse events were the most consistent predictors of PRO impairment (all p <0.05).ConclusionsPROs are minimally impacted by SOF + RBV regimens. An additional 12 weeks of treatment does not substantially add to the PRO burden.