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BMJ Open. 2019 Jun 19;9(6):e023405. doi: 10.1136/bmjopen-2018-023405.

Cost-effectiveness analysis of sofosbuvir plus ribavirin in patients with genotype 2 chronic hepatitis C: an analysis with real world outcomes from a multicentre cohort in Japan.

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Department of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Bunkyo, Tokyo, Japan.
Unit of Public Health and Preventive Medicine, Yokohama City University School of Medicine, Yokohama, Kanagawa, Japan.
Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan.
The Center for Liver Disease, Shin-Kokura Hospital, Kitakyushu, Japan.
Department of Internal Medicine, Chihaya Hospital, Fukuoka, Japan.
Department of Hepatology, Steel Memorial Yawata Hospital, Kitakyushu, Japan.
Department of Medicine, Hamanomachi Hospital, Fukuoka, Japan.
Department of Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.
Department of Medicine, Kyushu Central Hospital, Fukuoka, Japan.
Center for Liver Disease, National Hospital Organization Kokura Medical Center, Kitakyushu, Japan.
Department of Gastroenterology, Kyushu Medical Center, National Hospital Organization, Fukuoka, Japan.
Department of Medicine, Fukuoka City Hospital, Fukuoka, Japan.
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Department of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Kajiwara Clinic, Kitakyushu, Japan.
Kyushu General Internal Medicine Center, Haradoi Hospital, Fukuoka, Japan.



A number of publications have demonstrated the cost-effectiveness of sofosbuvir plus ribavirin (SOF+RBV) compared with the former standard therapy with interferon (IFN)-containing regimens. Unlike these cost-effective analyses, where efficacy parameters were obtained from registration trials for drug approval, this analysis is a cost-effectiveness analysis of SOF+RBV for genotype (GT) 2 non-cirrhosis (NC) and compensated cirrhosis (CC) patients using efficacy parameters obtained from a multicentre cohort study (Kyushu University Liver Disease Study; KULDS) in Kyushu area in Japan in order to reflect real-world clinical practice in Japan.


A Markov model followed 10 000 patients (62 years old) over their lifetime. Four populations were followed: treatment-naïve (TN)-NC, treatment-experienced (TE)-NC, TN-CC and TE-CC. Comparators were Peg-IFNα2b+RBV for TN-NC and CC patients and telaprevir (TVR)+Peg-IFNα2b+RBV for TE-NC patients. The sustained virological response (SVR) rates of SOF+RBV were taken from KULDS and those of comparators were obtained from systematic literature reviews. There were nine states (NC, CC, decompensated cirrhosis [DC], hepatocellular carcinoma [HCC], SVR [NC], SVR [CC], liver transplantation [LT], post-LT and death) in this model, and an increase in the progression rate to HCC due to ageing was also considered. The analysis was conducted from the perspective of a public healthcare payer, and a discount rate of 2% was set for both cost and effectiveness.


Incremental cost-effectiveness ratios (ICERs) of SOF+RBV versus Peg-IFNα2b+RBV were ¥323 928 /quality-adjusted life year (QALY) for TN-NC patients, ¥92 256/QALY for TN-CC patients and ¥1 519 202/QALY for TE-CC patients. The ICER of SOF+RBV versus TVR+Peg-IFNα2b+RBV was ¥849 138/QALY for TE-NC patients. The robustness of the results was determined by sensitivity analysis.


The results of this analysis strongly demonstrate the robustness of our previous findings that SOF+RBV regimens are cost-effective in the real world and clinical trial settings for Japanese GT2 NC and CC patients.


health economics; hepatology; public health

Conflict of interest statement

Competing interests: AI received the research grants from Gilead Sciences K.K., for this study. He received grants from AbbVie GK., grants from Abbott Japan Inc., grants from Beckton Dickinson and Company, personal fees from Chugai Pharmaceuticals Inc., personal fees from Astellas Pharma Inc., grants from Eli Lilly Japan K.K., personal fees from CSL Behring Japan Inc., personal fees from Fuji film Inc., personal fees from Takeda Pharmaceutical Inc., grants from Milliman Inc., grants from Creativ-Ceuticals Inc., grants from PFIZER INC., grants from Intuitive Surgical G.K., personal fees from Sanofi Japan Inc., grants from Terumo corporation, outside the submitted work.

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