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Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B.

Authors :
Lim YS
Chan HLY
Ahn SH
Seto WK
Ning Q
Agarwal K
Janssen HLA
Pan CQ
Chuang WL
Izumi N
Fung S
Shalimar
Brunetto M
Hui AJ
Chang TT
Lim SG
Abramov F
Flaherty JF
Wang H
Yee LJ
Kao JH
Gane E
Hou J
Buti M
Source :
JHEP reports : innovation in hepatology [JHEP Rep] 2023 Jul 13; Vol. 5 (10), pp. 100847. Date of Electronic Publication: 2023 Jul 13 (Print Publication: 2023).
Publication Year :
2023

Abstract

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.<br />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.<br />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).<br />Conclusions: This evaluation provides evidence that treatment with TAF or TDF can reduce HCC risk in patients with CHB, particularly in patients without cirrhosis.<br />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.<br />Clinical Trial Numbers: NCT01940341; NCT02836249; NCT01940471; NCT02836236.<br />Competing Interests: AJH: There are no financial disclosures for this author. CP: Has served as a speaker for Gilead and received research grants from Gilead. DRS: There are no financial disclosures for this author. EG: Member of scientific advisory boards for AbbVie, Abbott Diagnostics, Aligos, Arbutus, Arrowhead, Assembly, Avalia, Clear B Therapeutics, Dicerna, Enanta, Gilead Sciences, GSK, Intellia, Janssen, Merck, Novartis, Genentech-Roche, Vaccitech, Ventorx, Vir Bio and Virion Therapeutics. FA: Gilead Sciences employee and stock ownership. HJ: Received grants from: AbbVie, Gilead Sciences, GSK, Janssen, Roche, Vir Biotechnology Inc. Is a consultant for: Aligos, Antios, Arbutus, Eiger, Gilead Sciences, GSK, Janssen, Merck, Roche, VBI Vaccines, Vir Biotechnology Inc., Viroclinics. HC: Has served as an advisor for Aligos, Arbutus, Hepion, Janssen, Gilead, GSK, Roche, Vaccitech, Vir Biotechnology, Virion Therapeutic, and as a speaker for Gilead, Roche, and Mylan. HW: Employee and stockholder for Gilead. JF: Employee and stockholder for Gilead. JK: Consultant for Abbvie, Abbott, Gilead Sciences, Roche and Sysmex. On speaker’s bureaus for Abbvie, Bristol-Myers Squibb, Gilead Sciences, and Fujirebio. JH: Has received consulting fee from AbbVie, Arbutus, Bristol Myers Squibb, Gilead Sciences, Johnson & Johnson, Roche and received grants from Bristol Myers Squibb and Johnson & Johnson. KA: Aligos, Assembly, Bluejay, BMS, BI, DrugFarm, Gilead, GSK, Janssen, Merck, Roche, Sobi. LJY: Employee of Gilead Sciences and own stock in Gilead Sciences. MB: Has served as an advisor for Abbvie, Arbutus, Assembly, Janssen, Gilead, GSK, Roche, and as a speaker for Gilead and Abbvie. MBr: Speakers Bureau for AbbVie and Gilead. Advisory for AbbVie, Gilead, Janssen, Roche, EISAI-MSD. NI: There are no financial disclosures for this author. QN: Has served as a consultant for BMS, GSK, MSD, and Novartis. SHA: Has acted as advisors and investigator for Gilead, Janssen, AbbVie, Roche, Assembly Biosciences, Arbutus, Brii, Vaccitech, GSK, Inovio, Aligos, Vir Biotechnology, SL Vaxigen, GeneOne Life Science, GreenCross, Yuhan, Samil and Ildong. SF: Has received research support from Gilead. Consultant for Abbvie, Assembly Bio, Janssen, and Gilead. Teacher and speaking for Abbvie and Gilead. SGL: Speakers bureau for Gilead, Janssen, Roche, Sysmex. Advisory board for Gilead, Abbott, Roche, GSK, Janssen, Sysmex, Springbank, Arbutus, Assembly, Grifols, Eisai. Research support from Gilead, Abbott, Roche, Sysmex, Fibronostics, Merck. TTC: There are no financial disclosures for this author. WLC: Member of Advisory Board for Gilead, AbbVie, BMS, Roche, and PharmaEssentia. Speaker for Gilead, AbbVie, BMS, Roche, PharmaEssentia. WKS: Received speaker’s fees from Mylan and AstraZeneca, is an advisory board member of Abbott, is an advisory board member and received speaker’s fees from AbbVie, and is an advisory board member, received speaker’s fees and research funding from Gilead Sciences. YSL: Advisor/consultant/speaker for AbbVie, Assembly Biosciences, Bayer Healthcare, GlaxoSmithKline, Gilead Sciences, Janssen, Olix Pharmaceuticals, Roche, Vaccitech, and Vir Biotechnology; and received grant/research support from Gilead Sciences. Please refer to the accompanying ICMJE disclosure forms for further details.<br /> (© 2023 The Author(s).)

Details

Language :
English
ISSN :
2589-5559
Volume :
5
Issue :
10
Database :
MEDLINE
Journal :
JHEP reports : innovation in hepatology
Publication Type :
Academic Journal
Accession number :
37771546
Full Text :
https://doi.org/10.1016/j.jhepr.2023.100847