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

Abstract

BACKGROUND & AIMS:

A recent study in Asian patients with chronic hepatitis B (CHB) reported that the incidence of hepatocellular carcinoma (HCC) was lower in patients treated with tenofovir disoproxil fumarate (TDF) than entecavir (ETV), but this finding remains controversial. We aimed to identify any differences in HCC incidence, or other patient outcomes, between patients receiving TDF or ETV in the well monitored, multicenter European PAGE-B cohort.

METHODS:

We included 1,935 Caucasians with CHB, with or without compensated cirrhosis, treated with ETV (n = 772) or TDF (n = 1,163) monotherapy. Mean follow-up was 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), with no significant difference in any patient subgroup (with or without cirrhosis, naïve 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 patients with CHB, with or without cirrhosis, long-term ETV or TDF monotherapy is associated with similar HCC risk, rates of biochemical/virological remission, HBsAg loss and liver transplantation or death, but elastographic reversion of cirrhosis at year 5 was more frequent with TDF.

LAY SUMMARY:

In a large cohort of Caucasians with chronic hepatitis B treated with entecavir (ETV) or tenofovir disoproxil fumarate (TDF) monotherapy, cumulative rates of hepatocellular carcinoma did not differ (up to 12 years). Nor did rates of biochemical/virological remission, HBsAg loss and liver transplantation or death. However, elastographic reversion of cirrhosis at year 5 was more frequent in TDF- than ETV-treated patients with pretreatment cirrhosis.

• Authors: 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 Yurdaydin, Rafael Esteban, Harry L A Janssen, Thomas Berg, Pietro Lampertico
• Journal: Journal of hepatology (J Hepatol) Vol. 73 Issue 5 Pg. 1037-1045 (11 2020) ISSN: 1600-0641 [Electronic] Netherlands
• PMID: 32553667 (Publication Type: Journal Article)
• Copyright: Copyright © 2020 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Chemical References

• Antiviral Agents
• entecavir
• Guanine
• Tenofovir

Topics

• Antiviral Agents (therapeutic use)
• Carcinoma, Hepatocellular (epidemiology, pathology, virology)
• Elasticity Imaging Techniques (methods, statistics & numerical data)
• Female
• Follow-Up Studies
• Guanine (analogs & derivatives, therapeutic use)
• Hepatitis B virus (drug effects, isolation & purification)
• Hepatitis B, Chronic (complications, diagnosis, drug therapy, ethnology)
• Humans
• Incidence
• Liver Cirrhosis (diagnostic imaging, etiology, therapy)
• Liver Neoplasms (epidemiology, pathology, virology)
• Liver Transplantation (statistics & numerical data)
• Male
• Middle Aged
• Risk Assessment
• Tenofovir (therapeutic use)
• White People (statistics & numerical data)