Similar 5-year HCC occurrence in Tenofovir- and Entecavir-treated HBV chronic infection in the French AFEF/ANRS CO22 Hepather cohort.

Tytuł:: Similar 5-year HCC occurrence in Tenofovir- and Entecavir-treated HBV chronic infection in the French AFEF/ANRS CO22 Hepather cohort.
Autorzy:: Pol S; Assistance Publique - Hôpitaux de Paris, Hôpital Cochin, Unité d'Hépatologie, Paris, France.; Université Paris Descartes, INSERM U-1223, Institut Pasteur, Paris, France.
Corporate Authors:: ANRS/AFEF study group
Źródło:: Alimentary pharmacology & therapeutics [Aliment Pharmacol Ther] 2021 Mar; Vol. 53 (5), pp. 616-629. Date of Electronic Publication: 2021 Jan 19.
Typ publikacji:: Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
Język:: English
Imprint Name(s):: Publication: Oxford : Wiley-Blackwell
Original Publication: [Oxford, OX] : Blackwell Scientific Publications, [c1987-
MeSH Terms:: Carcinoma, Hepatocellular*/drug therapy
Carcinoma, Hepatocellular*/epidemiology
Hepatitis B, Chronic*/drug therapy
Hepatitis B, Chronic*/epidemiology
Liver Neoplasms*/drug therapy
Liver Neoplasms*/epidemiology
Antiviral Agents/adverse effects ; Guanine/analogs & derivatives ; Hepatitis B virus ; Humans ; Prospective Studies ; Tenofovir/adverse effects ; Treatment Outcome
References:: Torre LA, Bray F, Siegel RL, et al. Global cancer statistics, 2012. CA Cancer J Clin. 2015;65:87-108.
Llovet JM, Zucman-Rossi J, Pikarsky E, et al. Hepatocellular carcinoma. Nat Rev Dis Primers. 2016;2:16018.
Stanaway JD, Flaxman AD, Naghavi M, et al. The global burden of viral hepatitis from 1990 to 2013: findings from the Global Burden of Disease Study 2013. Lancet. 2016;10:1081-1088.
European Association for the Study of the Liver. Electronic address: ; 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.
European Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012;56:908-943.
Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Clin Liver Dis. 2018;12:33-34.
Sarin SK, Kumar M, Lau GK, et al. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int. 2016;10:1-98.
Bruix J, Sherman M, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011;56:1020-1022.
Beasley RP, Hwang LY, Lin CC, Chien CS. Hepatocellular carcinoma and hepatitis B virus. A prospective study of 22 707 men in Taiwan. Lancet. 1981;2:1129-1133.
Balsitis S, Gali V, Mason PJ, et al. Safety and efficacy of anti-PD-L1 therapy in the woodchuck model of HBV infection. PLoS One. 2018;13:e0190058.
Chang MH, Chen CJ, Lai MS, et al. Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. N Eng J Med. 1997;336:1855-1859.
McMahon BJ, Bulkow LR, Singleton RJ, et al. Elimination of hepatocellular carcinoma and acute hepatitis B in children 25 years after a hepatitis B newborn and catch-up immunization program. Hepatology. 2011;54:801-807.
Posuwan N, Wanlapakom N, Sa-Nquanmoo P, et al. The success of universal hepatitis B immunization program as part of Thailand's EPI after 22 years' implementation. PLoS One. 2016;11:e0510499.
Qu C, Chen T, Fan C, et al. Efficacy of neonatal HBV vaccination on liver cancer and other liver diseases over 30-year follow-up of the Qidong hepatitis B intervention study: a cluster randomized controlled trial. PLoS Medicine. 2014;11:e1001774.
Iloeje UH, Yang HI, Su J, et al. Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer-In HBV (the REVEAL-HBV) study Group. Gastroenterology. 2006;130:678-686.
Liaw YF, Sheen IS, Lee CM, et al. Tenofovir disoproxil fumarate (TDF), emtricitabine/TDF, and entecavir in patients with decompensated chronic hepatitis B liver disease. Hepatology. 2011;53:62-72.
Liaw YF, Sung JJ, Chow WC, et al. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med. 2004;351:1521-1531.
Marcellin P, Gane E, Buti M, et al. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet. 2013;9:468-475.
Chang TT, Liaw YF, Wu SS, et al. Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology. 2010;51:422-430.
Heathcote EJ, Marcellin P, Buti M, et al. Three-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B. Gastroenterology. 2011;140:132-143.
Ono A, Suzuki F, Kawamura Y, et al. Long-term continuous entecavir therapy in nucleos(t)ide-naive chronic hepatitis B patients. J Hepatol. 2012;57:508-514.
Sung JJ, Tsoi KK, Wong VW, Li KC, Chan HL. Meta-analysis: treatment of hepatitis B infection reduces risk of hepatocellular carcinoma. Aliment Pharmacol Ther. 2008;28:1067-1077.
Hosaka T, Suzuki F, Kobayashi M, et al. Clearance of hepatitis B surface antigen during long-term nucleot(s)ide analog treatment in chronic hepatitis B: results from a nine-year longitudinal study. J Gastroenterol. 2013;48:930-941.
Ahn J, Lim JK, Lee HM, et al. Lower observed hepatocellular carcinoma incidence in chronic hepatitis B patients treated with entecavir: results of the ENUMERATE Study. Am J Gastroenterol. 2016;111:1297-1304.
Kim WR, Loomba R, Berg T, et al. Impact of long-term tenofovir disoproxil fumarate on incidence of hepatocellular carcinoma in patients with chronic hepatitis B. Cancer. 2015;121:3631-3638.
Zhang Z, Zhou Y, Yang J, et al. The effectiveness of TDF versus ETV on incidence of HCC in CHB patients: a meta analysis. BMC Cancer. 2019;19:511.
Choi J, Kim HJ, Lee J, et al. Risk of hepatocellular carcinoma in patients treated with entecavir vs tenofovir for chronic hepatitis B. A Korean nationwide cohort study. JAMA Oncol. 2019;5:30-36.
Zuo SR, Zuo XC, Wang CJ, et al. A meta-analysis comparing the efficacy of entecavir and tenofovir for the treatment of chronic hepatitis B infection. J Clin Pharmacol. 2015;55:288-297.
Goyal SK, Dixit VK, Shukla SK, et al. Prolonged use of tenofovir and entecavir in hepatitis B virus-related cirrhosis. Indian J Gastroenterol. 2015;34:286-291.
Köklü S, Tuna Y, Gülşen MT, et al. Long-term efficacy and safety of lamivudine, entecavir, and tenofovir for treatment of hepatitis B virus-related cirrhosis. Clin Gastroenterol Hepatol. 2013;11:88-94.
Choi J, Han S, Kim N, Lim YS. Increasing burden of liver cancer despite extensive use of antiviral agents in a hepatitis B virus-endemic population. Hepatology. 2017;66:1454-1463.
Yu JH, Jin YJ, Lee JW, Lee DH. Remaining hepatocellular carcinoma risk in chronic hepatitis B patients receiving entecavir/tenofovir in South Korea. Hepatol Res. 2018;48:862-871.
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.
Carrat F, Fontaine H, Dorival C, et al. Clinical outcomes in patients with chronic hepatitis C after direct-acting antiviral treatment: a prospective cohort study. Lancet. 2019;393:1453-1464.
Croquet V, Vuillemin E, Ternisien C, et al. Prothrombin index is an indirect marker of severe liver fibrosis. Eur J Gastroenterol Hepatol. 2002;14:1133-1141.
Oberti F, Valsesia E, Pilette C, et al. Noninvasive diagnosis of hepatic fibrosis or cirrhosis. Gastroenterology. 1997;113:1609-1616.
Bedossa P, Poynard T. An algorithm for the grading of activity in chronic hepatitis C. The METAVIR Cooperative Study Group. Hepatology. 1996;24:289-293.
Matsuura M, Eguchi S. Modeling late entry bias in survival analysis. Biometrics. 2005;61:559-566.
Yip TC, Wong GL, Chan HL, et al. HBsAg seroclearance further reduces hepatocellular carcinoma risk after complete viral suppression with nucleos(t)ide analogues. J Hepatol. 2019;70:361-370.
Chan HL, Tse CH, Mo F, et al. High viral load and hepatitis B virus subgenotype are associated with increased risk of hepatocellular carcinoma. J Clin Oncol. 2008;26:177-182.
Ringelhan M, Protzer U. Oncogenic potential of hepatitis B virus encoded proteins. Curr Opin Virol. 2015;14:109-115.
Kremsdorf D, Soussan P, Paterlini-Brechot P, Brechot C. Hepatitis B virus-related hepatocellular carcinoma: paradigms for viral-related human carcinogenesis. Oncogene. 2006;26:3823-3833.
Hou J, Zhao W, Hann LC, et al. Outcomes of long-term treatment of chronic HBV infection with entecavir or other agents from a randomized trial in 24 countries. Clin Gastroenterol Hepatol. 2020;18:457-467.
Murata K, Asano M, Mtsumoto A, et al. Induction of IFN-λ3 as an additional effect of nucleotide, not nucleoside, analogues: a new potential target for HBV infection. Gut. 2018;67:362-371.
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.
Su F, Berry K, Ioannou GN. No difference in hepatocellular carcinoma risk between chronic hepatitis B patients treated with entecavir versus tenofovir. Gut. 2020;gutjnl-2019-319867. https://doi.org/10.1136/gutjnl-2019-319867.
Contributed Indexing:: Investigator: D Bonnet; V Payssan-Sicart; C Pomes; F Bailly; M Beaudoin; D Giboz; K Hartig-Lavie; M Maynard; E Billaud; D Boutoille; M Cavellec; C Chevalier; I Hubert; P Goepfert; A Lannes; F Lunel; J Boursier; N Boyer; N Giuily; C Castelnau; G Scoazec; A Chibah; S Keser; K Bonardi; A Vallet-Pichard; P Sogni; J Foucher; JB Hiriart; A Legendre; F Chermak; M Irlès-Depé; SN Si Ahmed; C Ansaldi; NB Amara; V Oules; J Dunette; R Anty; E Gelsi; R Truchi; E Luckina; N Messaoudi; J Moussali; B De Dieuleveult; H Goin; D Labarrière; P Potier; SN Si Ahmed; V Grando-Lemaire; P Nahon; S Brulé; R Monard; C Jezequel; A Brener; A Laligant; A Rabot; I Renard; TF Baumert; M Dofföel; C Mutter; P Simo-Noumbissie; E Razi; H Barraud; M Bensenane; A Nani; S Hassani-Nani; MA Bernard; GP Pageaux; M Bismuth; L Caillo; S Faure; MP Ripault; C Bureau; S Launay; JM Peron; MA Robic; L Tarallo; M Faure; B Froissart; MN Hilleret; JP Zarski; O Goria; V Grard; H Montialoux; M François; C Ouedraogo; C Pauleau; A Varault; T Andreani; B Angoulevant; A Chevance; L Serfaty; T Antonini; A Coilly; JC Duclos Vallée; M Tateo; C Bonny; C Brigitte; G Lamblin; L Muti; A Babouri; V Filipe; C Barrault; L Costes; H Hagège; S Merbah; P Carrier; M Debette-Gratien; J Jacques; G Lassailly; F Artu; V Canva; S Dharancy; A Louvet; M Latournerie; M Bardou; T Mouillot; Y Bacq; D Barbereau; C Nicolas; C Chevalier; I Archambeaud; S Habes; NB Amara; D Botta-Fridlund; E Saillard; MJ Lafrance
Substance Nomenclature:: 0 (Antiviral Agents)
5968Y6H45M (entecavir)
5Z93L87A1R (Guanine)
99YXE507IL (Tenofovir)
Entry Date(s):: Date Created: 20210119 Date Completed: 20210331 Latest Revision: 20220531
Update Code:: 20240105
DOI:: 10.1111/apt.16197
PMID:: 33464621
: Czasopismo naukowe

Pełny tekst

Background: Chronic hepatitis B virus (HBV) infection results in a high risk of cirrhosis and its complications, cirrhosis decompensation (DC), hepatocellular carcinoma (HCC), liver transplantation (LT), death or any of these outcomes (composite endpoint [CE]). Nucleos(t)ide analogues (NUCs) such as tenofovir or entecavir are associated with a reduction in these complications.
Aim: To compare the impact of tenofovir and entecavir on these outcomes in patients treated for HBV infection and included in the prospective Hepather cohort.
Methods: All patients with HBV infection who had received tenofovir or entecavir for more than 6 months at or after entry in the ANRS CO22 cohort were selected. Patients with HDV and HCV co-infection or prior liver event were excluded. Incidence rates of events were compared using inverse probability of treatment weighting (IPW).
Results: The cohort included 1800 patients (986 tenofovir and 814 entecavir). Median follow-up was 4.2 years. The incidences of HCC, DC, LT, ACD, LRD and CE were not different between tenofovir- (1.8 (0.9; 3.2), 0.6 (0.2; 1.6), 0.2 (0.0; 0.8), 1.7 (0.8; 3.0), 0.8 (0.2, 1.8) and 4.1 (3.0; 5.4) per 1000 person-years) and entecavir-treated patients (1.6 (0.7; 3.0), 0.7 (0.2; 1.8), 0.2 (0.0; 1.0), 3.0 (1.7, 4.8), 0.5 (0.1; 1.5) and 5.0 (3.3; 7.2)) per 1000 person-years, respectively.
Conclusion: The risk of liver-related events or death was not different between tenofovir- and entecavir-treated patients in this large prospective cohort of predominantly non-cirrhotic French patients.
Trial Registration Number: NCT019553458.
(© 2020 John Wiley & Sons Ltd.)

Comment in: Aliment Pharmacol Ther. 2021 Mar;53(5):659. (PMID: 33566398)
Comment in: Aliment Pharmacol Ther. 2021 Mar;53(5):657-658. (PMID: 33566425)
Comment in: Aliment Pharmacol Ther. 2021 May;53(9):1050. (PMID: 33831235)
Comment in: Aliment Pharmacol Ther. 2021 May;53(9):1048-1049. (PMID: 33831238)
Erratum in: Aliment Pharmacol Ther. 2021 Nov;54(10):1364-1365. (PMID: 34699103)

Zaloguj się, aby uzyskać dostęp do pełnego tekstu.

Informacja