Effect of tenofovir alafenamide vs. tenofovir disoproxil fumarate on hepatocellular carcinoma risk in chronic hepatitis B.
comparison
hepatocellular carcinoma
prevention
tenofovir alafenamide
tenofovir disoproxil fumarate
Journal
Journal of viral hepatitis
ISSN: 1365-2893
Titre abrégé: J Viral Hepat
Pays: England
ID NLM: 9435672
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
revised:
27
07
2021
received:
10
05
2021
accepted:
17
08
2021
pubmed:
27
8
2021
medline:
3
2
2022
entrez:
26
8
2021
Statut:
ppublish
Résumé
It is unclear whether tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) is more effective for preventing hepatocellular carcinoma (HCC) development in patients with chronic hepatitis B (CHB). In this study, we compared the effectiveness of these two antiviral agents for preventing HCC. We included treatment-naïve CHB patients undergoing antiviral therapy with TDF only (TDF group) or a TAF-based regimen (TAF group) at three academic teaching hospitals from 2012 to 2019. The TAF group included patients receiving TAF as first-line treatment and patients switching from TDF to TAF. Patients with decompensated cirrhosis or HCC at enrollment were excluded. Cumulative probabilities of HCC were assessed using Kaplan-Meier methodology. In total, 2,117 patients were included: 1,832 in the TDF group and 285 in the TAF group. The annual HCC incidence was not significantly different between TDF and TAF groups: 1.66 vs. 1.19 per 100 person-years [PY], respectively (multivariate analysis: adjusted hazard ratio [HR] 0.774 [reference: TDF group]; p = .438). Male, liver cirrhosis, hepatitis B e antigen negativity, Fibrosis-4 index>3.25 and low albumin were independently associated with a higher risk of HCC. Propensity score-matched and inverse probability of treatment weighting analyses yielded similar results: 1.56 vs. 1.19 per 100 PY, respectively (HR 1.175; p = .708) and 1.66 vs. 1.29 per 100 PY, respectively (HR 0.888; p = .446). The risk of HCC development was not significantly different between TDF and TAF groups of CHB patients. Further studies with a larger sample size and longer follow-up are required to validate our results.
Substances chimiques
Antiviral Agents
0
Tenofovir
99YXE507IL
tenofovir alafenamide
EL9943AG5J
Alanine
OF5P57N2ZX
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1570-1578Informations de copyright
© 2021 John Wiley & Sons Ltd.
Références
Park SH, Plank LD, Suk KT, et al. Trends in the prevalence of chronic liver disease in the Korean adult population, 1998-2017. Clin Mol Hepatol. 2020;26:209-215.
Yim HJ, Kim JH, Park JY, et al. Comparison of clinical practice guidelines for the management of chronic hepatitis B: when to start, when to change, and when to stop. Clin Mol Hepatol. 2020;26:411-429.
European Association for the Study of the Liver. EASL 2017 clinical practice guidelines on the management of hepatitis B virus infection. J Hepatol. 2017;67:370-398.
Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018;67:1560-1599.
Korean Association for the Study of the Liver (KASL). KASL clinical practice guidelines for liver cirrhosis: varices, hepatic encephalopathy, and related complications. Clin Mol Hepatol. 2020;26:83-127.
Shin J, Yu JH, Jin YJ, et al. Acute-on-chronic liver failure as a major predictive factor for mortality in patients with variceal bleeding. Clin Mol Hepatol. 2020;26:540-553.
Con D, Goodwin T, Majeed A, et al. Comparison of 48-week efficacy of tenofovir vs entecavir for patients with chronic hepatitis B: a network meta-analysis. J Viral Hepat. 2021;28:40-50.
Lampertico P, Buti M, Fung S, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. Lancet Gastroenterol Hepatol. 2020;5:441-453.
Choi J, Han S, Kim N, et al. Increasing burden of liver cancer despite extensive use of antiviral agents in a hepatitis B virus-endemic population. Hepatology. 2017;66:1454-1463.
Ha Y, Chon YE, Kim MN, et al. Hepatocellular carcinoma and death and transplantation in chronic hepatitis B treated with entecavir or tenofovir disoproxil fumarate. Sci Rep. 2020;10:13537.
Kim SU, Seo YS, Lee HA, et al. A multicenter study of entecavir vs. tenofovir on prognosis of treatment-naïve chronic hepatitis B in South Korea. J Hepatol. 2019;71:456-464.
Papatheodoridis GV, Dalekos GN, Idilman R, et al. Similar risk of hepatocellular carcinoma during long-term entecavir or tenofovir therapy in Caucasian patients with chronic hepatitis B. J Hepatol. 2020;73:1037-1045.
Yip TC, Wong VW, Chan HL, et al. Tenofovir is associated with lower risk of hepatocellular carcinoma than entecavir in patients with chronic HBV infection in China. Gastroenterology. 2020;158:215-225.e6.
Cheung KS, Mak LY, Liu SH, et al. Entecavir vs tenofovir in hepatocellular carcinoma prevention in chronic hepatitis B infection: a systematic review and meta-analysis. Clin Transl Gastroenterol. 2020;11:e00236.
Lee SW, Kwon JH, Lee HL, et al. Comparison of tenofovir and entecavir on the risk of hepatocellular carcinoma and mortality in treatment-naïve patients with chronic hepatitis B in Korea: a large-scale, propensity score analysis. Gut. 2020;69:1301-1308.
Buti M, Gane E, Seto WK, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016;1:196-206.
Chan HL, Fung S, Seto WK, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016;1:185-195.
Lim YS, Chan HL, Seto WK, et al. Impact of treatment with tenofovir alafenamide or tenofovir disoproxil fumarate on hepatocellular carcinoma incidence in patients with chronic hepatitis B. Hepatology. 2019;70:126A.
Maruyama H, Kato N. Advances in ultrasound diagnosis in chronic liver diseases. Clin Mol Hepatol. 2019;25:160-167.
Yang JD. Detect or not to detect very early stage hepatocellular carcinoma? The western perspective. Clin Mol Hepatol. 2019;25:335-343.
Esfeh JM, Hajifathalian K, Ansari-Gilani K. Sensitivity of ultrasound in detecting hepatocellular carcinoma in obese patients compared to explant pathology as the gold standard. Clin Mol Hepatol. 2020;26:54-59.
European Association for the Study of the Liver. EASL clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2018;69:182-236.
Heimbach JK, Kulik LM, Finn RS, et al. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018;67:358-380.
Lee S, Kim SS, Chang DR, et al. Comparison of LI-RADS 2018 and KLCA-NCC 2018 for noninvasive diagnosis of hepatocellular carcinoma using magnetic resonance imaging. Clin Mol Hepatol. 2020;26:340-351.
Kim YY, Park MS, Aljoqiman KS, et al. Gadoxetic acid-enhanced magnetic resonance imaging: hepatocellular carcinoma and mimickers. Clin Mol Hepatol. 2019;25:223-233.
Shin H, Jung YW, Kim BK, et al. Risk assessment of hepatocellular carcinoma development for indeterminate hepatic nodules in patients with chronic hepatitis B. Clin Mol Hepatol. 2019;25:390-399.
Kim J, Kang W, Sinn DH, et al. Substantial risk of recurrence even after 5 recurrence-free years in early-stage hepatocellular carcinoma patients. Clin Mol Hepatol. 2020;26:516-528.
Yoon SM, Kim SY, Lim YS, et al. Stereotactic body radiation therapy for small (≤5 cm) hepatocellular carcinoma not amenable to curative treatment: results of a single-arm, phase II clinical trial. Clin Mol Hepatol. 2020;26:506-515.
Lee SB, Jeong J, Park JH, et al. Low-level viremia and cirrhotic complications in patients with chronic hepatitis B according to adherence to entecavir. Clin Mol Hepatol. 2020;26:364-375.
Ahn KS, Kang KJ. Appropriate treatment modality for solitary small hepatocellular carcinoma: radiofrequency ablation vs. resection vs. transplantation? Clin Mol Hepatol. 2019;25:354-359.
Chao X, Qian H, Wang S, et al. Autophagy and liver cancer. Clin Mol Hepatol. 2020;26:606-617.
Lee S, Choi EJ, Cho EJ, et al. Inhibition of PI3K/Akt signaling suppresses epithelial-to-mesenchymal transition in hepatocellular carcinoma through the Snail/GSK-3/beta-catenin pathway. Clin Mol Hepatol. 2020;26:529-539.
Liu Y, Wang X, Yang Y. Hepatic Hippo signaling inhibits development of hepatocellular carcinoma. Clin Mol Hepatol. 2020;26:742-750.
Choi J, Kim GA, Han S, et al. Earlier alanine aminotransferase normalization during antiviral treatment is independently associated with lower risk of hepatocellular carcinoma in chronic hepatitis B. Am J Gastroenterol. 2020;115:406-414.
Wong GL, Chan HL, Tse YK, et al. Normal on-treatment ALT during antiviral treatment is associated with a lower risk of hepatic events in patients with chronic hepatitis B. J Hepatol. 2018;69:793-802.
Kim EJ, Yeon JE, Kwon OS, et al. Rapid alanine aminotransferase normalization with entecavir and hepatocellular carcinoma in hepatitis B virus-associated cirrhosis. Dig Dis Sci. 2017;62:808-816.
Liang LY, Wong GL. Unmet need in chronic hepatitis B management. Clin Mol Hepatol. 2019;25:172-180.
Kim KS, Lee BW. Beneficial effect of anti-diabetic drugs for nonalcoholic fatty liver disease. Clin Mol Hepatol. 2020;26:430-443.
Hsiang JC, Wong GL, Tse YK, et al. Statin and the risk of hepatocellular carcinoma and death in a hospital-based hepatitis B-infected population: a propensity score landmark analysis. J Hepatol. 2015;63:1190-1197.
Lee HW, Kim EH, Lee J, et al. Natural history of untreated HBeAg-positive chronic HBV infection with persistently elevated HBV DNA but normal alanine aminotransferase. Clin Transl Gastroenterol. 2020;11:e00140.
Kim SU, Seo YS, Lee HA, et al. Hepatocellular carcinoma risk steadily persists over time despite long-term antiviral therapy for hepatitis B: a multicenter study. Cancer Epidemiol Biomarkers Prev. 2020;29:832-837.
Lee HW, Kim SU, Park JY, et al. Prognosis of untreated minimally active chronic hepatitis B patients in comparison with virological responders by antivirals. Clin Transl Gastroenterol. 2019;10:e00036.
Liu S, Zhou B, Valdes JD, et al. Serum HBV RNA: a new potential biomarker for chronic hepatitis B virus infection. Hepatology. 2019;69(4):1816-1827.
Inoue T, Tanaka Y. Novel biomarkers for the management of chronic hepatitis B. Clin Mol Hepatol. 2020;26:261-279.
Lall S, Agarwala P, Kumar G, et al. The dilemma of differentiating between acute hepatitis B and chronic hepatitis B with acute exacerbation: Is quantitative serology the answer? Clin Mol Hepatol. 2020;26:187-195.
Coffin CS, Zhou K, Terrault NA. New and old biomarkers for diagnosis and management of chronic hepatitis B virus infection. Gastroenterology. 2019;156:355-68.e3.
Kim HS, Kim SU, Kim BK, et al. Serum Wisteria floribunda agglutinin-positive human Mac-2 binding protein level predicts recurrence of hepatitis B virus-related hepatocellular carcinoma after curative resection. Clin Mol Hepatol. 2020;26:33-44.