Objective The cost-effectiveness of antiviral treatment in adult immune-tolerant (IT) phase chronic hepatitis B (CHB) patients is uncertain.
Design We designed a Markov model to compare expected costs and quality-adjusted life-years (QALYs) of starting antiviral treatment at IT-phase (‘treat-IT’) vs delaying the therapy until active hepatitis phase (‘untreat-IT’) in CHB patients over a 20-year horizon. A cohort of 10 000 non-cirrhotic 35-year-old patients in IT-phase CHB (hepatitis B e antigen-positive, mean serum hepatitis B virus (HBV) DNA levels 7.6 log10 IU/mL, and normal alanine aminotransferase levels) was simulated. Input parameters were obtained from previous studies at Asan Medical Center, Korea. The incremental cost-effectiveness ratio (ICER) between the treat-IT and untreat-IT strategies was calculated.
Results From a healthcare system perspective, the treat-IT strategy with entecavir or tenofovir had an ICER of US$16 516/QALY, with an annual hepatocellular carcinoma (HCC) incidence of 0.73% in the untreat-IT group. With the annual HCC risk ≥0.54%, the treat-IT strategy was cost-effective at a willingness-to-pay threshold of US$20 000/QALY. From a societal perspective considering productivity loss by premature death, the treat-IT strategy was extremely cost-effective, and was dominant (ICER <0) if the HCC risk was ≥0.43%, suggesting that the treat-IT strategy incurs less costs than the untreat-IT strategy. The most influential parameters on cost-effectiveness of the treat-IT strategy were those related with HCC risk (HBV DNA levels, platelet counts and age) and drug cost.
Conclusion Starting antiviral therapy in IT phase is cost-effective compared with delaying the treatment until the active hepatitis phase in CHB patients, especially with increasing HCC risk, decreasing drug costs and consideration of productivity loss.
- antiviral therapY
- hepatitis B
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H-LK and G-AK are joint first authors.
Contributors All authors have full access to all data used in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. The principal investigators Y-SL and E-KL were responsible for the conception and design of the study; the acquisition, analysis and interpretation of the data and the drafting of the manuscript. H-LK and G-AK were responsible for the design of the study; the acquisition, analysis and interpretation of the data and the drafting of the manuscript. J-AP and H-RK contributed to the literature search and data collection and assembly. All authors approved the definitive version of the manuscript for submission.
Funding This study was supported by grants from the Korean National Health Clinical Research (NHCR) project, Ministry of Health & Welfare, Republic of Korea (HC15C3380); National Evidence-based Healthcare Collaborating Agency (NECA, No. NS-19-004); Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number : HI19C0790).; National Research Foundation of Korea (NRF) grant funded by the Korean government (MSIT, 2017R1A2B4011233); and the Technology Innovation Program (10079271) funded by the Ministry of Trade, Industry & Energy (MOTIE) of the Republic of Korea.
Competing interests Y-SL is an advisory board member of Bayer Healthcare and Gilead Sciences. Y-SL also receives research funding from Bayer Healthcare and Gilead Sciences.
Patient consent for publication Not required.
Ethics approval This study was approved by the institutional review board of AMC (IRB No. 2016-0304).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.
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