Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B
Background & Aims: Antiviral therapy may attenuate the risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB). We aimed to explore how tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF) affect HCC risk in patients with CHB. Methods: The REACH-B, aM...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-10-01
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| Series: | JHEP Reports |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589555923001787 |
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| author | Young-Suk Lim Henry L.Y. Chan Sang Hoon Ahn Wai Kay Seto Qin Ning Kosh Agarwal Harry L.A. Janssen Calvin Q. Pan Wan Long Chuang Namiki Izumi Scott Fung Shalimar Maurizia Brunetto Aric Josun Hui Ting-Tsung Chang Seng Gee Lim Frida Abramov John F. Flaherty Hongyuan Wang Leland J. Yee Jia-Horng Kao Edward Gane Jinlin Hou Maria Buti |
| author_facet | Young-Suk Lim Henry L.Y. Chan Sang Hoon Ahn Wai Kay Seto Qin Ning Kosh Agarwal Harry L.A. Janssen Calvin Q. Pan Wan Long Chuang Namiki Izumi Scott Fung Shalimar Maurizia Brunetto Aric Josun Hui Ting-Tsung Chang Seng Gee Lim Frida Abramov John F. Flaherty Hongyuan Wang Leland J. Yee Jia-Horng Kao Edward Gane Jinlin Hou Maria Buti |
| author_sort | Young-Suk Lim |
| collection | DOAJ |
| description | Background & Aims: Antiviral therapy may attenuate the risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB). We aimed to explore how tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF) affect HCC risk in patients with CHB. Methods: The REACH-B, aMAP, and mPAGE-B models were utilized to assess HCC risk in patients with CHB from two global randomized-controlled trials evaluating the impact of TAF vs. TDF treatment. Standard incidence ratios (SIRs) were calculated using data from the REACH-B model as a ratio of observed HCC cases in the TAF- or TDF-treated patients vs. predicted HCC cases for untreated historical controls. Proportions of treated patients shifting aMAP and mPAGE-B risk categories between baseline and Week 240 were calculated. Results: Of the 1,632 patients (TAF, n = 1,093; TDF, n = 539) followed for up to 300 weeks, 22 HCC cases developed. Those receiving TAF had an SIR that was lower compared to the SIR of individuals receiving TDF: 0.32 (p <0.001) vs. 0.56 (p = 0.06). In the general study population, individuals without cirrhosis at baseline had an SIR that was lower compared to the SIR of individuals with cirrhosis at baseline: 0.37 (p <0.001) vs. 0.58 (p = 0.15). Of the patients at low risk of HCC at baseline, the majority (97%) remained low risk by mPAGE-B and aMAP scoring at Week 240. Among those at medium or high risk at baseline, substantial portions shifted to a lower risk category by Week 240 (mPAGE-B: 22% and 42%; aMAP: 39% and 63%, respectively). Conclusions: This evaluation provides evidence that treatment with TAF or TDF can reduce HCC risk in patients with CHB, particularly in patients without cirrhosis. Impact and implications: Despite the substantial impact of HCC on long-term outcomes of patients with CHB, the differential risk of HCC development among those receiving treatment with TAF vs. TDF has not been well elucidated. Using three validated risk prediction models, we found that TAF is at least as effective as TDF in reducing HCC risk in patients with CHB. While TDF is well-studied in the context of HCC risk reduction, our novel findings underscore the effectiveness of TAF as a treatment option for patients with CHB. Clinical trial numbers: NCT01940341; NCT02836249; NCT01940471; NCT02836236. |
| first_indexed | 2024-03-11T22:25:53Z |
| format | Article |
| id | doaj.art-6fa5ef22c05d4c2b921cc10c1111b3f7 |
| institution | Directory Open Access Journal |
| issn | 2589-5559 |
| language | English |
| last_indexed | 2024-03-11T22:25:53Z |
| publishDate | 2023-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | JHEP Reports |
| spelling | doaj.art-6fa5ef22c05d4c2b921cc10c1111b3f72023-09-24T05:16:35ZengElsevierJHEP Reports2589-55592023-10-01510100847Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis BYoung-Suk Lim0Henry L.Y. Chan1Sang Hoon Ahn2Wai Kay Seto3Qin Ning4Kosh Agarwal5Harry L.A. Janssen6Calvin Q. Pan7Wan Long Chuang8Namiki Izumi9Scott Fung10 Shalimar11Maurizia Brunetto12Aric Josun Hui13Ting-Tsung Chang14Seng Gee Lim15Frida Abramov16John F. Flaherty17Hongyuan Wang18Leland J. Yee19Jia-Horng Kao20Edward Gane21Jinlin Hou22Maria Buti23Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea; Corresponding author. Address: Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of KoreaThe Chinese University of Hong Kong, Hong KongYonsei University College of Medicine, Seoul, Republic of KoreaUniversity of Hong Kong, Hong KongTongji Hospital, Tongji Medical College, Wuhan, ChinaInstitute of Liver Studies, Kings College Hospital, United KingdomToronto Western Hospital, Toronto, ON, Canada; Division of Gastroenterology & Hepatology, Erasmus Medical Center, Rotterdam, The NetherlandsNYU Langone Health, NYU Grossman School of Medicine, New York, NY, USAKaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, TaiwanMusashino Red Cross Hospital, Tokyo, JapanDepartment of Medicine, University of Toronto, Toronto, CanadaAll India Institute of Medical Sciences, New Delhi, Delhi, IndiaUniversity Hospital of Pisa, Pisa, ItalyAlice Ho Miu Ling Nethersole Hospital, Hong KongNational Cheng Kung University Medical College, Tainan, TaiwanNational University Hospital, SingaporeGilead Sciences, Foster City, CA, USAGilead Sciences, Foster City, CA, USAGilead Sciences, Foster City, CA, USAGilead Sciences, Foster City, CA, USANational Taiwan University College of Medicine and National Taiwan University Hospital, Taipei, TaiwanAuckland Clinical Studies, Auckland, New ZealandNanfang Hospital of Southern Medical University, Guangzhou, ChinaHospital Universitario Vall d’Hebron, Barcelona, Spain; CIBEREHD del Instituto Carlos III., Barcelona, SpainBackground & Aims: Antiviral therapy may attenuate the risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB). We aimed to explore how tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF) affect HCC risk in patients with CHB. Methods: The REACH-B, aMAP, and mPAGE-B models were utilized to assess HCC risk in patients with CHB from two global randomized-controlled trials evaluating the impact of TAF vs. TDF treatment. Standard incidence ratios (SIRs) were calculated using data from the REACH-B model as a ratio of observed HCC cases in the TAF- or TDF-treated patients vs. predicted HCC cases for untreated historical controls. Proportions of treated patients shifting aMAP and mPAGE-B risk categories between baseline and Week 240 were calculated. Results: Of the 1,632 patients (TAF, n = 1,093; TDF, n = 539) followed for up to 300 weeks, 22 HCC cases developed. Those receiving TAF had an SIR that was lower compared to the SIR of individuals receiving TDF: 0.32 (p <0.001) vs. 0.56 (p = 0.06). In the general study population, individuals without cirrhosis at baseline had an SIR that was lower compared to the SIR of individuals with cirrhosis at baseline: 0.37 (p <0.001) vs. 0.58 (p = 0.15). Of the patients at low risk of HCC at baseline, the majority (97%) remained low risk by mPAGE-B and aMAP scoring at Week 240. Among those at medium or high risk at baseline, substantial portions shifted to a lower risk category by Week 240 (mPAGE-B: 22% and 42%; aMAP: 39% and 63%, respectively). Conclusions: This evaluation provides evidence that treatment with TAF or TDF can reduce HCC risk in patients with CHB, particularly in patients without cirrhosis. Impact and implications: Despite the substantial impact of HCC on long-term outcomes of patients with CHB, the differential risk of HCC development among those receiving treatment with TAF vs. TDF has not been well elucidated. Using three validated risk prediction models, we found that TAF is at least as effective as TDF in reducing HCC risk in patients with CHB. While TDF is well-studied in the context of HCC risk reduction, our novel findings underscore the effectiveness of TAF as a treatment option for patients with CHB. Clinical trial numbers: NCT01940341; NCT02836249; NCT01940471; NCT02836236.http://www.sciencedirect.com/science/article/pii/S2589555923001787REACH-BaMAPmPAGE-Bincidenceantiviral therapy |
| spellingShingle | Young-Suk Lim Henry L.Y. Chan Sang Hoon Ahn Wai Kay Seto Qin Ning Kosh Agarwal Harry L.A. Janssen Calvin Q. Pan Wan Long Chuang Namiki Izumi Scott Fung Shalimar Maurizia Brunetto Aric Josun Hui Ting-Tsung Chang Seng Gee Lim Frida Abramov John F. Flaherty Hongyuan Wang Leland J. Yee Jia-Horng Kao Edward Gane Jinlin Hou Maria Buti Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B JHEP Reports REACH-B aMAP mPAGE-B incidence antiviral therapy |
| title | Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B |
| title_full | Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B |
| title_fullStr | Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B |
| title_full_unstemmed | Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B |
| title_short | Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B |
| title_sort | tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis b |
| topic | REACH-B aMAP mPAGE-B incidence antiviral therapy |
| url | http://www.sciencedirect.com/science/article/pii/S2589555923001787 |
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