Patient-reported outcomes in chronic hepatitis C: The impact of placebo, active treatment, and sustained viral eradication.
Younossi Z, Stepanova M, Manns MP, Reddy R, Gordon SC, and Bourliere M. Patient-reported outcomes in chronic hepatitis C: The impact of placebo, active treatment, and sustained viral eradication. J Hepatol 2018; 68:S312.
Background and Aims: Clearance of HCV infection is known to improve quality of life and other patient-reported outcomes (PROs). To longitudinally assess changes in PROs in patients with HCV infection who were initially randomized to placebo and then subsequently received SOF/VEL/VOX for 12 weeks in a “deferred treatment” study. Method: HCV-infected patients who received 12 weeks of placebo in the POLARIS-1 study were subsequently treated with SOF/VEL/VOX (400 mg/100 mg/100 mg) daily for 12 weeks. During placebo treatment and active treatment periods, PROs were prospectively collected using SF-36v2, CLDQ-HCV, FACIT-F, and WPAI:SHP assessing 26 PRO domains. Results: Of 147 HCV patients included, most were male (79%), white (82%), 33% had cirrhosis, and 99% had HCV genotype 1. The SVR-12 rate was 97%. During treatment with placebo, there were no significant changes in any PRO domains from patients' own baseline levels (all p > 0.05) except for the Worry domain of CLDQ-HCV. However, soon after the initiation of SOF/VEL/VOX, significant PRO improvements were noted in a number of PRO domains. Byweek 4 of active treatment, scores improved in 6/26 PRO domains (+2.4% to +8.1%, p < 0.05) and continued to improve until the end of treatment week 12 in 14/26 PRO domains (+2.0% to +8.3%, p < 0.05). Achieving SVR was associated with improvement in 24/26 PRO domain scores by post-treatment week 12 and in 23/26 domain scores by posttreatmentweek 24 (+3.2% to +14.9%). The greatest PRO improvements were observed in the domains of Vitality, Activity, and Presenteeism (>8% of a PRO range size). In multivariate analysis, being viremic was associated with significantly impaired PRO scores: β ranging from -2.4% to -8.5%, p < 0.05 for all but one PRO. Conclusion: This study shows that PROs do not change during placebo treatment but significantly improve with active DAA treatment and with sustained viral eradication. These data provides strong evidence supporting the positive impact of HCV viral suppression on PROs. (Figure Presented) .