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McEwan P, Ward T, Webster S, et al. Estimating the Long-Term Clinical and Economic Outcomes of Daclatasvir Plus Asunaprevir in Difficult-to-Treat Japanese Patients Chronically Infected with Hepatitis C Genotype 1b. Value Health Reg Issues. 2014;3:136-145doi: 10.1016/j.vhri.2014.04.005.
McEwan, P., Ward, T., Webster, S., Yuan, Y., Kalsekar, A., Broglio, K., Kamae, I., Quintana, M., Berry, S. M., Kobayashi, M., Inoue, S., Tang, A., & Kumada, H. (2014). Estimating the Long-Term Clinical and Economic Outcomes of Daclatasvir Plus Asunaprevir in Difficult-to-Treat Japanese Patients Chronically Infected with Hepatitis C Genotype 1b. Value in health regional issues, 3136-145. https://doi.org/10.1016/j.vhri.2014.04.005
McEwan, Phil, et al. "Estimating the Long-Term Clinical and Economic Outcomes of Daclatasvir Plus Asunaprevir in Difficult-to-Treat Japanese Patients Chronically Infected with Hepatitis C Genotype 1b." Value in health regional issues vol. 3 (2014): 136-145. doi: https://doi.org/10.1016/j.vhri.2014.04.005
McEwan P, Ward T, Webster S, Yuan Y, Kalsekar A, Broglio K, Kamae I, Quintana M, Berry SM, Kobayashi M, Inoue S, Tang A, Kumada H. Estimating the Long-Term Clinical and Economic Outcomes of Daclatasvir Plus Asunaprevir in Difficult-to-Treat Japanese Patients Chronically Infected with Hepatitis C Genotype 1b. Value Health Reg Issues. 2014 May;3:136-145. doi: 10.1016/j.vhri.2014.04.005. Epub 2014 May 21. PMID: 29702919.
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Value Health Reg Issues. 2014 May;3:136-145. doi: 10.1016/j.vhri.2014.04.005. Epub 2014 May 21.

Estimating the Long-Term Clinical and Economic Outcomes of Daclatasvir Plus Asunaprevir in Difficult-to-Treat Japanese Patients Chronically Infected with Hepatitis C Genotype 1b.

Value in health regional issues

Phil McEwan, Thomas Ward, Samantha Webster, Yong Yuan, Anupama Kalsekar, Kristine Broglio, Isao Kamae, Melanie Quintana, Scott M Berry, Masahiro Kobayashi, Sachie Inoue, Ann Tang, Hiromitsu Kumada

Affiliations

  1. Health Economics and Outcomes Research Ltd., Monmouth, UK; Centre for Health Economics, Swansea University, Swansea, UK.
  2. Health Economics and Outcomes Research Ltd., Monmouth, UK. Electronic address: [email protected].
  3. Health Economics and Outcomes Research Ltd., Monmouth, UK.
  4. Global Health Economics and Outcomes Research, Bristol-Myers Squibb, Princeton, NJ, USA.
  5. Berry Consultants, LLC, Austin, TX, USA.
  6. Graduate School of Public Policy, University of Tokyo, Tokyo, Japan.
  7. Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
  8. CRECON Research and Consulting, Inc., Tokyo, Japan.
  9. Health Economics and Outcomes Research, Bristol-Myers K.K., Tokyo, Japan.

PMID: 29702919 DOI: 10.1016/j.vhri.2014.04.005

Abstract

OBJECTIVES: Japan has one of the highest endemic rates of hepatitis C virus (HCV) infection. Treatments in Japan are currently limited to interferon-alfa-based regimens, which are associated with tolerability and efficacy issues. A novel regimen combining two oral HCV therapies, daclatasvir and asunaprevir (DCV + ASV), has shown favorable results in Japanese patients with chronic genotype 1b HCV infection. Comparisons of clinical and economic outcomes associated with DCV + ASV treatment and current standards of care were investigated.

METHODS: The MOdelling the NAtural histoRy and Cost-effectiveness of Hepatitis cost-effectiveness model projected outcomes in 1000 patients aged 70 years with either chronic hepatitis C or compensated cirrhosis over a lifetime simulation. Japanese-specific disease transition rates were used, and discounting was applied annually at a rate of 2%. Efficacy data for DCV + ASV and telaprevir triple therapy (telaprevir + pegylated interferon-alfa + ribavirin [TVR + pegIFN-α/RBV]) were obtained from a Japanese subgroup analysis found within a global meta-analysis: sustained virological response rates of 74%, 85%, and 87% were reported for null responders (NRs), partial responders (PRs), and interferon-alfa-ineligible/intolerant patients, respectively, treated with DCV + ASV, and rates of 42% and 59% were reported for NRs and PRs, respectively, treated with TVR + pegIFN-α/RBV.

RESULTS: Initiating DCV + ASV treatment in patients in the chronic hepatitis C disease stage resulted in quality-adjusted life-year gains of 0.96 and 0.77 over TVR + pegIFN-α/RBV for NRs and PRs, respectively, and a gain of 2.61 in interferon-alfa-ineligible/intolerant patients over no treatment. Similarly, quality-adjusted life-year gains of 1.11, 0.90, and 3.05 were observed when initiating treatment in patients in the compensated cirrhosis stage. Cumulative lifetime events of decompensated cirrhosis, hepatocellular carcinoma, and liver-related mortality were reduced by up to 66, 115, and 128, respectively, with DCV + ASV treatment.

CONCLUSIONS: There is a lack of successful therapies for patients with HCV who have previously failed to achieve sustained virological response or are ineligible for interferon-alfa-based therapies. Results demonstrate that the provision of an alternative, interferon-alfa-free regimen, such as DCV + ASV, offers significant value in terms of avoiding life-threatening liver complications and increasing patients' quality of life.

Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Keywords: asunaprevir; clinical effectiveness; daclatasvir; hepatitis C

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