行业资讯
评估慢乙肝患者换用集采恩替卡韦的疗效与安全性
发布时间:2023-11-05 来源: 访问:
我国国产ETV疗效稳定,与进口ETV相比,在疗效与安全性方面无差异,是很多患者首选的抗病毒药物[9][10]。国产ETV疗效确切,但价格昂贵。集采ETV,一月仅需5.5元,显著减轻慢乙肝患者口服药物费用负担。虽然集采药物一般会经过三期临床试验观察后投入使用,但目前没有确切的文献报道集采ETV有效性与安全性。本研究发现:两组患者完全病毒学应答率无统计学差异,但未换药组和换药组中分别有3人(3/104,2.88%)和5人(5/156,3.21%)间歇HBVDNA阳性(均在20IU/ml—2000IU/ml),即为低病毒血症,患HCC风险较高,这可能是由于患者出现耐药,应检测是否耐药并调整NAs治疗,推荐选择新一代抗病毒药物TAF[6][16]。有大量研究表明服用ETV治疗患者换为TAF治疗后可提高或维持完全病毒学应答率[17][18]。由于本研究为回顾性分析,纳入研究时限较短,未追踪患者后续治疗方案及效果;两组患者在不同节点均有ALT波动,无统计学差异,这可能与患者饮食、休息、劳累、饮酒等有关,必要时可行口服保肝药物治疗[6];HBeAg阴转率及HBeAg/抗-HBe血清学转换率均无明显统计学差异(P值均>0.05)。
综上所述,集采恩替卡韦为安全抗病毒药物,且价格低廉,可广泛用于临床。本试验的不足之处在于试验周期较短,纳入患者数量较少,应增加病例、延长抗病毒疗程进一步观察集采恩替卡韦的抗病毒疗效与安全性,为临床指导用药提供更充分的证据。
参考文献
[1] undefined[M] .Geneva: World Health Organization, 2015.
[2]Liu Jue,Liang Wannian,Jing Wenzhan et al. Countdown to 2030: eliminating hepatitis B disease, China.[J] .Bull World Health Organ, 2019, 97: 230-238.
[3]Ren X, Xu Z, Liu Y, et al. Hepatitis B virus genotype and basal core promoter/precore mutations are associated with hepatitis B-related acute-on-chronic liver failure without pre-existing liver cirrhosis. J Viral Hepat.2010;17(12):887895.doi:10.1111/j.1365-2893.2009.01254.x
[4]Su Feng,Berry Kristin,Ioannou George N,No difference in hepatocellular carcinoma risk between chronic hepatitis B patients treated with entecavir versus tenofovir.[J] .Gut, 2021, 70: 370-378.
[5]Terrault Norah A,Lok Anna S F,McMahon Brian J etal. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance.[J] .Hepatology, 2018, 67: 1560-1599.
[6] 中华医学会感染病学分会,中华医学会肝病学分会.慢性乙型肝炎防治指南(2019年版)[J].临床肝胆病杂志,2019,35(12):2648-2669.
[7] European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu, European Association for the Study of the Liver,EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection.[J] .J Hepatol, 2017, 67: 370-398.
[8] Yao K, Liu J, Wang J, Yan X, Xia J, Yang Y, Wu W, Liu Y, Chen Y, Zhang Z, Li J, Huang R, Wu C. Distribution and clinical characteristics of patients with chronic hepatitis B virus infection in the grey zone. J Viral Hepat. 2021 Jul;28(7):1025-1033. doi: 10.1111/jvh.13511. Epub 2021 Apr 26. PMID: 33797145.
[9]徐东平,李进,张玲霞.恩替卡韦治疗慢性乙型肝炎的研究进展[J].中华医学杂志,2006,86(28):2014-2016.
[10]吕睿.慢性乙型病毒性肝炎抗病毒治疗进展[J].现代医药卫生,2013,29(2):220-224.
[11] Wieland SF, Chisari FV. Stealth and cunning: hepatitis B and hepatitis C viruses. J Virol.2005;79(15):9369-9380. doi:10.1128/JVI.79.15.9369-9380.2005
[12] Yan H, Zhong G, Xu G, et al. Sodium taurocholate cotransporting polypeptide is a functional receptor for human hepatitis B and D virus [published correction appears in Elife. 2014;3:e05570]. Elife. 2012;1:e00049. Published 2012 Nov 13. doi:10.7554/eLife.00049
[13] Seeger C, Mason WS. Hepatitis B virus biology. Microbiol Mol Biol Rev. 2000;64(1):51-68. doi:10.1128/MMBR.64.1.51-68.2000
[14] Tan A, Koh S, Bertoletti A. Immune Response in Hepatitis B Virus Infection. Cold Spring Harb Perspect Med. 2015;5(8):a021428. Published 2015 Jul 1. doi:10.1101/cshperspect.a021428
[15]Zhang Z, Zhou Y, Yang J, Hu K, Huang Y. The effectiveness of TDF versus ETV on incidence of HCC in CHB patients: a meta analysis. BMC Cancer. 2019;19(1):511. Published 2019 May 29. doi:10.1186/s12885-019-5735-9
[16] Yip TC, Wong GL, Chan HL, Tse YK, Lam KL, Lui GC, Wong VW. HBsAg seroclearance further reduces hepatocellular carcinoma risk after complete viral suppression with nucleos(t)ide analogues. J Hepatol. 2019 Mar;70(3):361-370. doi: 10.1016/j.jhep.2018.10.014. Epub 2018 Oct 25. PMID: 30367899.
[17] Ogawa E, Nomura H, Nakamuta M, Furusyo N, Koyanagi T, Dohmen K, Ooho A, Satoh T, Kawano A, Kajiwara E, Takahashi K, Azuma K, Kato M, Shimoda S, Hayashi J; Kyushu University Liver Disease Study (KULDS) Group. Tenofovir alafenamide after switching from entecavir or nucleos(t)ide combination therapy for patients with chronic hepatitis B. Liver Int. 2020 Jul;40(7):1578-1589. doi: 10.1111/liv.14482. Epub 2020 Apr 30. PMID: 32304611.
[18] Li ZB, Li L, Niu XX, Chen SH, Fu YM, Wang CY, Liu Y, Shao Q, Chen G, Ji D. Switching from entecavir to tenofovir alafenamide for chronic hepatitis B patients with low-level viraemia. Liver Int. 2021 Jun;41(6):1254-1264. doi: 10.1111/liv.14786. Epub 2021 Jan 19. PMID: 33404182.
相关文章