title: Health utilities using SF-6D scores in Japanese patients with chronic hepatitis C treated with sofosbuvir-based regimens in clinical trials.
abstract: BACKGROUND
  Health utilities are preference-based measures for health states which are typically used in economic analyses to estimate quality-adjusted life years. Our aim is to report the standard SF-6D health utility scores in Japanese patients with hepatitis C virus (HCV) during treatment with different regimens.
  
  
  METHODS
  Japanese patients were enrolled in clinical trials of sofosbuvir (SOF) used in combination with or without ledipasvir (LDV) and/or ribavirin (RBV). The SF-6D health utility scores were calculated at multiple time points from the SF-36 instrument.
  
  
  RESULTS
  Four hundred ninety-four patients with HCV (genotype 1 and 2) were enrolled: 19% with cirrhosis, 48% with a prior history of anti-HCV treatment. Of those, 153 received SOF + RBV, 170 received LDV/SOF + RBV, 171 received LDV/SOF for 12 weeks; the SVR rates were: 97, 98 and 100%, respectively. Patients treated with the three regimens had similar SF-6D scores before treatment (p = 0.87): 76.1 ± 11.5. During treatment with RBV containing regimen, patients experienced a decrement in their health utility scores to 74.3 ± 12.5 by the end of treatment (p = 0.03), while patients treated with RBV-free LDV/SOF had their SF-6D scores improved to 79.2 ± 12.8 after 12 weeks of treatment (p = 0.0004). At post-treatment week 12, in patients who achieved SVR-12, the SF-6D scores were similar between the treatment regimens (p = 0.36), and an average improvement of +1.4 points from baseline (p = 0.01) was noted. In multivariate analysis, the use of RBV was independently associated with lower utility score during treatment (beta = 4.7 ± 1.6, p < 0.0001).
  
  
  CONCLUSIONS
  Health utilities are lower in Japanese HCV patients and tend to improve after clearance of infection.
authors.affiliation: Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA. zobair.younossi@inova.org.|Department of Medicine, Beatty Liver and Obesity Research Program, Inova Fairfax Hospital, Falls Church, VA, USA. zobair.younossi@inova.org.|Betty and Guy Beatty Center for Integrated Research, Claude Moore Health Education and Research Building, 3300 Gallows Road, Falls Church, VA, 22042, USA. zobair.younossi@inova.org.
authors.forename: Zobair
authors.initials: Z
authors.lastname: Younossi
authors.affiliation: Center for Outcomes Research in Liver Diseases, Washington, DC, USA.
authors.forename: Maria
authors.initials: M
authors.lastname: Stepanova
authors.affiliation: Yamanashi Prefectural Hospital Organization, Yamanashi, Japan.
authors.forename: Masao
authors.initials: M
authors.lastname: Omata
authors.affiliation: Kohnodai Hospital, National Center for Global Health and Medicine, Chiba, Japan.
authors.forename: Masashi
authors.initials: M
authors.lastname: Mizokami
authors.affiliation: Center for Outcomes Research in Liver Diseases, Washington, DC, USA.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Walters
authors.affiliation: Center for Outcomes Research in Liver Diseases, Washington, DC, USA.
authors.forename: Sharon
authors.initials: S
authors.lastname: Hunt
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D004359:Drug Therapy, Combination; D005260:Female; D005449:Fluorenes / Q000627:therapeutic use; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011594:Psychometrics; D011788:Quality of Life; D012254:Ribavirin / Q000627:therapeutic use; D000069474:Sofosbuvir / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; D012254:Ribavirin; D000069474:Sofosbuvir
keywords: HCV; Health utilities; Health-related quality of life; Interferon; Ledipasvir; Ribavirin; Sofosbuvir