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Am. J. Gastroenterol., 2023 Mar 7 | DOI: 10.14309/ajg.0000000000002234 Personalized Antiviral Drug Selection in Chronic Hepatitis B Patients Using a Machine Learning Model: A Multinational Study

Hur, Moon Haeng^1,*; Park, Min Kyung^1,*; Cheuk-Fung Yip, Terry^2,*; Chen, Chien-Hung^3,*; Lee, Hyung-Chul^4,*; Choi, Won-Mook^5,*; Kim, Seung Up⁶; Lim, Young-Suk⁵; Park, Soo Young⁷; Lai-Hung Wong, Grace²; Sinn, Dong Hyun⁸; Jin, Young-Joo⁹; Kim, Sung Eun¹⁰; Peng, Cheng-Yuan¹¹; Shin, Hyun Phil¹²; Chen, Chi-Yi¹³; Kim, Hwi Young¹⁴; Lee, Han Ah¹⁴; Seo, Yeon Seok¹⁵; Jun, Dae Won¹⁶; Yoon, Eileen L.^16,17; Sohn, Joo Hyun¹⁸; Ahn, Sang Bong¹⁹; Shim, Jae-Jun²⁰; Jeong, Soung Won²¹; Cho, Yong Kyun²²; Kim, Hyoung Su²³; Jang, Myoung-jin²⁴; Kim, Yoon Jun¹; Yoon, Jung-Hwan¹; Lee, Jeong-Hoon^1,a

¹Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea
²Medical Data Analytics Centre (MDAC), Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong SAR, China
³Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung niversity College of Medicine, Kaohsiung, Taiwan
4Department of Anesthesiology, Seoul National University College of Medicine, Seoul, Republic of Korea
⁵Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea
⁶Department of Internal Medicine and Yonsei Liver Center, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
⁷Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea
⁸Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
⁹Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, Republic of Korea
¹⁰Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea
¹¹Center for Digestive Medicine, Department of Internal Medicine, China Medical University Hospital, China Medical University, Taichung, Taiwan
¹²Department of Gastroenterology and Hepatology, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Republic of Korea
¹³Division of Hepatogastroenterology, Department of Internal Medicine, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chia-Yi, Taiwan
¹⁴Department of Internal Medicine, College of Medicine, Ewha Womans University, Seoul, Republic of Korea
¹⁵Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Republic of Korea
¹⁶Department of Internal Medicine, Hanyang University Hospital, Hanyang University College of Medicine, Seoul, Republic of Korea
¹⁷Department of Internal Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea
¹⁸Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Republic of Korea
¹⁹Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University College of Medicine, Seoul, Republic of Korea
²⁰Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Republic of Korea
²¹Department of Internal Medicine, Soonchunhyang University College of Medicine, Soonchunhyang University Seoul Hospital, Seoul, Republic of Korea
²²Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
²³Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea
²⁴Medical Research Collaboration Center, Seoul National University Hospital, Seoul, Republic of Korea

^aCorresponding author: Jeong-Hoon Lee, MD, PhD, Professor
^*These authors equally contributed to this study as co-first authors.

Abstract

Introduction: Tenofovir disoproxil fumarate (TDF) is reportedly superior or at least comparable to entecavir (ETV) for the prevention of hepatocellular carcinoma (HCC) in chronic hepatitis B (CHB) patients; however, it has distinct long-term renal and bone toxicities. This study aimed to develop and validate a machine learning model (designated as PLAN-S) to predict an individualized risk of HCC during ETV or TDF therapy.

Methods: This multinational study included 13,970 CHB patients. The derivation (n=6,790), Korean validation (n=4,543), and Hong Kong-Taiwan validation cohorts (n=2,637) were established. Patients were classified as the TDF-superior group when a PLAN-S-predicted HCC risk under ETV treatment is greater than under TDF treatment, and the others were defined as the TDF-nonsuperior group.

Results: The PLAN-S model was derived using eight variables and generated a c-index between 0.67 and 0.78 for each cohort. The TDF-superior group included a higher proportion of male and cirrhotic patients than the TDF-nonsuperior group. In the derivation, Korean validation, and Hong Kong-Taiwan validation cohorts, 65.3%, 63.5%, and 76.4% of patients were classified as the TDF-superior group, respectively. In the TDF-superior group of each cohort, TDF was associated with a significantly lower risk of HCC than ETV (hazard ratio=0.60-0.73, all P<0.05). In the TDF-nonsuperior group, however, there was no significant difference between the two drugs (hazard ratio=1.16-1.29, all P>0.1).

Discussion: Considering the individual HCC risk predicted by PLAN-S and the potential TDF-related toxicities, TDF and ETV treatment may be recommended for the TDF-superior and TDF-nonsuperior groups, respectively.

논문정보

형식Research article
게재일2023년 03월 (BRIC 등록일 2023-03-13)
연구진국내(교신)+국외 연구진
분야 의약학 > 응용의학

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