Similar risk of hepatocellular carcinoma during long-term entecavir or tenofovir therapy in Caucasian patients with chronic hepatitis B

George V. Papatheodoridis, George N. Dalekos, Ramazan Idilman, Vana Sypsa, Florian Van Boemmel, Maria Buti, Jose Luis Calleja, John Goulis, Spilios Manolakopoulos, Alessandro Loglio, Margarita Papatheodoridi, Nikolaos Gatselis, Rhea Veelken, Marta Lopez-Gomez, Bettina E. Hansen, Savvoula Savvidou, Anastasia Kourikou, John Vlachogiannakos, Kostas Galanis, Cihan YurdaydinRafael Esteban, Harry LA Janssen, Thomas Berg, Pietro Lampertico

Research output: Contribution to journalArticle

Abstract

BACKGROUND & AIMS: The incidence of hepatocellular carcinoma (HCC) was recently reported to be lower in Asian chronic hepatitis B (CHB) patients treated with tenofovir disoproxil fumarate (TDF) than entecavir (ETV), but this finding remains controversial. We assessed whether there was a difference between ETV and TDF treated patients of the well monitored, multicenter European PAGE-B cohort in the HCC incidence and other patient outcomes. METHODS: We included 1935 Caucasians with CHB, with or without compensated cirrhosis, treated with ETV (n=772) or TDF (n=1163) monotherapy. Mean follow-up has been 7.1±3.0 years from ETV/TDF onset. RESULTS: The 5-year cumulative HCC incidence was 5.4% in ETV and 6.0% in TDF treated patients (log-rank, P=0.321) without significant difference in any patient subgroup [with or without cirrhosis, naive or experienced to oral antiviral(s) (total, with or without cirrhosis)]. In multivariable Cox regression analyses, the hazard of HCC was similar between ETV and TDF treated patients after adjustment for several HCC risk factors. ETV and TDF treated patients had similar rates of on-therapy biochemical and virological remission, HBsAg loss, liver transplantation and/or death. Elastographic reversion of cirrhosis at year 5 (liver stiffness <12 kPa) was observed in 245/347 (70.6%) patients with pretreatment cirrhosis being more frequent in TDF than ETV treated patients (73.8% vs 61.5%, P=0.038). CONCLUSION: In Caucasian CHB patients, with or without cirrhosis, ETV and TDF long-term monotherapy is associated with similar HCC risk and rates of biochemical and virological remission, HBsAg loss and liver transplantation or death, but TDF seems to result in more frequent elastographic reversion of cirrhosis at year 5.

Original languageEnglish
JournalJournal of Hepatology
DOIs
Publication statusAccepted/In press - Jun 15 2020

Keywords

  • cirrhosis
  • liver cancer
  • liver stiffness
  • nucleoside analogue
  • nucleotide analogue
  • treatment

ASJC Scopus subject areas

  • Hepatology

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    Papatheodoridis, G. V., Dalekos, G. N., Idilman, R., Sypsa, V., Van Boemmel, F., Buti, M., Calleja, J. L., Goulis, J., Manolakopoulos, S., Loglio, A., Papatheodoridi, M., Gatselis, N., Veelken, R., Lopez-Gomez, M., Hansen, B. E., Savvidou, S., Kourikou, A., Vlachogiannakos, J., Galanis, K., ... Lampertico, P. (Accepted/In press). Similar risk of hepatocellular carcinoma during long-term entecavir or tenofovir therapy in Caucasian patients with chronic hepatitis B. Journal of Hepatology. https://doi.org/10.1016/j.jhep.2020.06.011