Hepatocellular carcinoma prediction beyond year 5 of oral therapy in a large cohort of Caucasian patients with chronic hepatitis B.

BACKGROUND & AIMS

Hepatocellular carcinoma (HCC) may develop in patients with chronic hepatitis (CHB) even after 5 years of oral therapy and cannot be easily predicted. We assessed predictors of HCC development and the need for HCC surveillance in this setting.

METHODS

Of 1,951 adult Caucasians with CHB included in the PAGE-B cohort, 1,427 (73%) had completed >5 years of follow-up under therapy without developing HCC by year 5. Median follow-up was 8.4 years from treatment onset. Points-based risk scores were developed to predict HCC risk after year 5.

RESULTS

In years 5-12, HCC was diagnosed in 33/1,427 (2.3%) patients with cumulative incidences of 2.4%, 3.2% and 3.8% at 8, 10 and 12 years, respectively. Older age or age >50 years, baseline cirrhosis and liver stiffness (LSM) ≥12 kPa at year 5 were independently associated with increased HCC risk. The HCC incidence was lower in non-cirrhotics than cirrhotics at baseline with year-5 LSM <12; among cirrhotics at baseline, it was lower in those with year-5 LSM <12 than ≥12 kPa. CAGE-B score was based on age at year 5 and baseline cirrhosis in relation to LSM at year 5 and SAGE-B score was based only on age and LSM at year 5 (c-index = 0.809-0.814, 0.805-0.806 after bootstrap validation). Both scores offered 100% negative predictive values for HCC development in their low risk groups.

CONCLUSIONS

In Caucasians with CHB, the HCC risk after the first 5 years of antiviral therapy depends on age, baseline cirrhosis status and LSM at year 5. CAGE-B and particularly SAGE-B represent simple and reliable risk scores for HCC prediction and surveillance beyond year 5 of therapy.

LAY SUMMARY

In Caucasians with chronic hepatitis B, the risk of hepatocellular carcinoma after the first 5 years of entecavir or tenofovir therapy depends on age, baseline cirrhosis status and liver stiffness at year 5, which can provide simple and reliable risk scores for hepatocellular carcinoma prediction and surveillance beyond year 5. In patients with cirrhosis at baseline, liver stiffness <12 kPa at year 5 is associated with lower HCC risk, but surveillance may be still required.

Informations de copyright

Copyright © 2020 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of interest GV Papatheodoridis: advisor/lecturer for Abbvie, Bristol-Myers Squibb, Dicerna, Gilead, GlaxoSmithKline, Ipsen, Janssen, Merck Sharp & Dohme, Roche, Spring Bank; research grants Abbvie, Bristol-Myers Squibb, Gilead. V Sypsa: advisor/lecturer for Abbvie, Gilead; research grants from Abbvie, Gilead. GN Dalekos: advisor/lecturer for Abbvie, Bayer, Genkyotex, Gilead, Ipsen, Janssen, Novartis, Pfizer, Roche; research grants from Abbvie, Gilead. C Yurdaydin: speaker's bureau and/or advisor for AbbVie, Bristol-Myers Squibb, Gilead, Merck, Roche; research grant from Bristol-Myers Squibb. F van Boemmel: advisor/lecturer for Abbvie, Bristol-Myers Squibb, Gilead, Janssen, Merck Sharp & Dohme, Novartis, Roche; research grants from Bristol-Myers Squibb, Gilead, Janssen, Roche, Siemens; consultant for Abbvie, Gilead, Roche. M Buti: advisor/lecturer for Abbvie, Arbutus, Bristol-Myers Squibb, Gilead, Glaxo Smith-Kleine, Merck, Roche, Spring Bank. JL Calleja: advisor/lecturer for Abbvie , Bristol-Myers Squibb, Gilead, Janssen, Merck. H Chi: Nothing to declare. J Goulis: advisor/lecturer for Gilead, GlaxoSmithKline, Merck Sharp & Dohme, Roche; research grant from Gilead. S Manolakopoulos: advisor/lecturer for Abbvie, Gilead, GlaxoSmithKline, Ipsen, Merck Sharp & Dohme, Novartis, Roche; research grants from Abbvie, Gilead. A Loglio: advisor/lecturer for Gilead, MYR Pharma. T Voulgaris: Nothing to declare. N Gatselis: Nothing to declare. O Keskın: Nothing to declare. R Veelken: Nothing to declare. M Lopez-Gomez: Nothing to declare. BE Hansen: Nothing to declare. S Savvidou: Nothing to declare. A Kourikou: Nothing to declare. I Vlachogiannakos: advisor/lecturer for Abbvie, Bristol-Myers Squibb, Gilead, Merck Sharp & Dohme, Novartis, Roche. K Galanis: Nothing to declare. R Idilman: Nothing to declare. R Esteban: advisor/lecturer for Abbvie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis. HLA Janssen: consultant for and grants from AbbVie, Arbutus, Bristol-Myers Squibb, Enyo, Gilead Sciences, Janssen, Medimmune, Merck, Roche, Vir Biotechnology Inc., Viroclinics. T Berg: advisor/consultant/lecturer for Abbvie, Alexion, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Janssen, Merck Sharp & Dohme/Merck, Novartis, Roche, and Vertex; Research support from Abbvie, Bristol-Myers Squibb, Gilead, Janssen, Merck Sharp & Dohme/Merck, Novartis and Roche. P Lampertico: speaking bureau/advisor for Abbvie, Eiger, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Merck/Merck Sharp & Dohme, MYR Pharma, Roche. Please refer to the accompanying ICMJE disclosure forms for further details.