Cost–utility analysis of sofosbuvir for the treatment of genotype 2 chronic hepatitis C in Japan

Abstract

Objective: Across Japan, around 2 million people are infected with hepatitis C virus (HCV) with long-term complications such as cirrhosis, hepatocellular carcinoma (HCC) and liver transplant (LT). Current treatment options have several limitations due to side effects, interferon intolerability and ineligibility, long treatment durations and low sustained virological responses (SVR) rates, especially for the most severe patients. Sofosbuvir (SOF) is the first nucleotide analog NS5B polymerase inhibitor with pan-genotypic activity. SOF, administered in combination with ribavirin (RBV) with or without pegylated interferon (PEGIFN) resulted in high SVR rates across genotype (GT) 1–6 patients. It is also the first available regimen for patients that are unsuitable for interferon. This analysis assessed the cost–utility ratio of sofosbuvir in GT2 patients in Japan.

Research design and methods: A Markov model followed a cohort of 10,000 GT2 patients until patients reached 100 years of age. Approximately 20% of patients initiated treatment at the cirrhotic stage. Comparators were based on the current recommendations in Japan, including PEGIFN with ribavirin (RBV), telaprevir (TVR) in combination with PEGIFN + RBV and no treatment. Costs and outcomes were discounted at 2%.

Results: Sofosbuvir was cost-effective across all the studied indications, especially in patients unsuitable for interferon, with incremental cost–effectiveness ratios (ICERs) lower than JPY 5,000,000. Compared to the other treatments included in the analysis, SOF + RBV resulted in improved clinical outcomes. Results were robust to sensitivity analyses.

Conclusion: SOF combined with RBV was shown to be cost-effective in GT2 patients in Japan. Compared to PEGIFN + RBV, TVR + PEGIFN + RBV and no treatment SOF offers a more efficacious, shorter and better tolerated treatment option and extends treatment to reach HCV-infected patients who are ineligible for interferon-based regimens. Although adverse events were not included in the analyses, this would not make any changes to our conclusion.

Keywords:

• Chronic hepatitis C infection
• Cost–utility analysis
• Genotype 2
• Japan
• Sofosbuvir

Transparency

Declaration of funding

This study was funded by Gilead Sciences.

Declaration of financial/other relationships

A.I. has disclosed that he received grants and personal fees from Pfizer Japan Inc., Gilead Science KK, Milliman Inc. and Terumo Co. Ltd., grants from CSL Behring Japan Inc., Intuitive Surgical Inc., Fuji Film KK, and TOWA Pharmaceuticals Co. Ltd., personal fees from Novartis Pharma KK, AbbVie GK, CRECON Research and Consulting Inc., Sony Inc., Kanter Health Inc., Astellas Pharma KK, Chugai Pharaceutical Co. Ltd., Eli Lilly Japan KK, Health and Global Policy Institute, American Medical Devices and Diagnostics Manufacturers’ Association, Bristol-Myers Squibb KK, Abbott Japan KK, outside the submitted work. S.C., I.G., and L.M. have disclosed that they are employees of Mapi, a company that received consulting fees from Gilead. M.L. has disclosed that he is an employee of Junicon Inc., another company that received funding from Gilead to help conduct this study. K.T. has disclosed that he received grants from the Association for Health Economics Research and Social Insurance and Welfare (ASIW, Japan), and Gilead Science KK.

AI, WT (doctoral candidate) and KT are affiliated to Department of Drug Policy & Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, an endowment laboratory supported with an unrestricted grant from TOWA Pharmaceuticals Co (Apr 2011-Sept 2015), and CSL Behring Japan Inc., Fuji Film K.K, Gilead Science K.K, Milliman Inc. and Terumo Co. Ltd. (Oct 2015 - Sep 2020).

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Notice of correction

Please note that the authors' full given names have replaced the first name initial since the article was first published online (08 September 2016).