在西班牙群体的慢性乙型肝炎患者中恩替卡韦或替诺福韦的

StephenW

Digestive Diseases and Sciences

March 2017, Volume 62, Issue 3,                        pp 784–793

Effectiveness and Safety of Entecavir or Tenofovir in a Spanish Cohort of Chronic Hepatitis B Patients: Validation of the Page-B Score to Predict Hepatocellular Carcinoma

• Authors
• Authors and affiliations
  
  

• Mar Riveiro-Barciela
• David Tabernero
• José L. Calleja
• Sabela Lens
• María L. Manzano
• Francisco Gea Rodríguez
• Javier Crespo
• Belén Piqueras
• Juan M. Pascasio
• Carmen Comas
• Maria L. Gutierrez
• Alberto Aguirre
• Emilio Suárez
• Javier García-Samaniego
• Miguel Rivero
• 
  

• Mar Riveiro-Barciela
  
  • 1
  • 2
    
• David Tabernero
  
  • 2
  • 3
    
• José L. Calleja
  
  • 2
  • 4
    
• Sabela Lens
  
  • 2
  • 5
    
• María L. Manzano
  
  • 6
    
• Francisco Gea Rodríguez
  
  • 7
    
• Javier Crespo
  
  • 8
    
• Belén Piqueras
  
  • 9
    
• Juan M. Pascasio
  
  • 2
  • 10
    
• Carmen Comas
  
  • 11
    
• Maria L. Gutierrez
  
  • 12
    
• Alberto Aguirre
  
  • 13
    
• Emilio Suárez
  
  • 14
    
• Javier García-Samaniego
  
  • 2
  • 15
    
• Miguel Rivero
  
  • 16
    
• Doroteo Acero
  
  • 17
    
• Miguel Fernandez-Bermejo
  
  • 18
    
• Diego Moreno
  
  • 19
    
• Pilar Sánchez-Pobre
  
  • 20
    
• Beatriz de Cuenca
  
  • 21
    
• J. J Moreno-Palomares
  
  • 22
    
• Rafael Esteban
  
  • 1
  • 2
    
• Maria Buti
  
  • 1
  • 2
    
  Email author

• 1.Liver Unit, Department of Internal MedicineHospital Universitari Vall d’Hebron and Universitat Autònoma de BarcelonaBarcelonaSpain
• 2.Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd)Instituto de Salud Carlos IIIMadridSpain
• 3.Liver Pathology Unit, Departments of Biochemistry and Microbiology (Virology Unit)Hospital Universitari Vall d’Hebron and Universitat Autònoma de BarcelonaBarcelonaSpain
• 4.Liver Unit, Hospital U. Puerta de HierroUniversidad Autonoma de MadridMajadahondaSpain
• 5.Liver Unit, Hospital Clínic de BarcelonaIDIBAPSBarcelonaSpain
• 6.Digestive Diseases DepartmentHospital Universitario 12 de octubreMadridSpain
• 7.Digestive Diseases DepartmentHospital Universitario Ramón y CajalMadridSpain
• 8.Gastroenterology and Hepatology Unit, Hospital Universitario Valdecilla, IDIVALFacultad de MedicinaSantanderSpain
• 9.Digestive Diseases DepartmentHospital Universitario de FuenlabradaFuenlabradaSpain
• 10.Digestive Diseases DepartmentHospital Universitario Virgen del RocíoSevilleSpain
• 11.Digestive Diseases DepartmentHospital Universitario Infanta SofíaSan Sebastián de los ReyesSpain
• 12.Digestive Diseases DepartmentHospital Universitario Fundación AlcorcónAlcorcónSpain
• 13.Digestive Diseases DepartmentHospital Universitario Severo OchoaLeganésSpain
• 14.Digestive Diseases DepartmentHospital Universitario Virgen de ValmeSevilleSpain
• 15.Liver Unit, Hospital Universitario La PazIdiPAZMadridSpain
• 16.Digestive Diseases DepartmentHospital Universitario del SuresteArganda del ReySpain
• 17.Digestive Diseases DepartmentHospital Universitario de Girona Dr. Josep TruetaGironaSpain
• 18.Digestive Diseases DepartmentHospital San Pedro de AlcántaraCáceresSpain
• 19.Digestive Diseases DepartmentHospital Universitario de MóstolesMóstolesSpain
• 20.Digestive Diseases DepartmentHospital Clínico San CarlosMadridSpain
• 21.Digestive Diseases DepartmentHospital Infanta CristinaParlaSpain
• 22.Internal Medicine DepartmentHospital General de SegoviaSegoviaSpain
  

Original ArticleFirst Online: 11 January 2017

DOI:            10.1007/s10620-017-4448-7

Cite this article as: Riveiro-Barciela, M., Tabernero, D., Calleja, J.L. et al. Dig Dis Sci (2017) 62: 784. doi:10.1007/s10620-017-4448-7
            

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AbstractBackground

Long-term antiviral therapy has resulted in viral suppression and biochemical response in chronic hepatitis B, although the risk of hepatocellular carcinoma has not been abolished. The Page-B score could be useful to estimate the probability of HCC.

Aims

To analyze the effectiveness and safety of entecavir or tenofovir for more than 4 years and the usefulness of Page-B score in the real-world setting.

Methods

Analysis of Caucasian chronic hepatitis B subjects treated with entecavir or tenofovir from the prospective, multicenter database CIBERHEP.

Results

A total of 611 patients were enrolled: 187 received entecavir and 424 tenofovir. Most were men, mean age 50 years, 32% cirrhotic and 16.5% HBeAg-positive. Mean follow-up was 55 (entecavir) and 49 (tenofovir) months. >90% achieved HBV DNA <69 IU/mL and biochemical normalization by months 12 and 36, respectively. Cumulative HBeAg loss and anti-HBe seroconversion were achieved by 33.7 and 23.8%. Four patients lost HBsAg; three HBeAg-positive. Renal function remained stable on long-term follow-up. Fourteen (2.29%) developed HCC during follow-up all of them with baseline Page-B ≥10. Nine were diagnosed within the first 5 years of therapy. This contrasts with the 27 estimated by Page-B, a difference that highlights the importance of regular HCC surveillance even in patients with virological suppression.

Conclusions

Entecavir and tenofovir achieved high biochemical and virological response. Renal function remained stable with both drugs. A Page-B cut-off ≥10 selected all patients at risk of HCC development.

KeywordsHepatitis BHepatocellular carcinomaPage-BTenofovirEntecavirEffectivenessSafety

StephenW

消化疾病和科学

2017年3月，第62卷，第3期，第784-793页
在西班牙群体的慢性乙型肝炎患者中恩替卡韦或替诺福韦的有效性和安全性：评估页面B评分以预测肝细胞癌

    作者
    作者和关系

    Mar Riveiro-BarcielaDavidTaberneroJoséL. CallejaSabelaLensMaríaL. ManzanoFrancisco GeaRodríguezJavierCrespoBelénPiquerasJuan M. PascasioCarmen ComasMaria L.Gutierrez Alberto AguirreEmilioSuárezJavierGarcía-SamaniegoMiguel Rivero

    Mar Riveiro-Barciela
        12
    大卫Tabernero
        23
    JoséL. Calleja
        24
    Sabela镜头
        25
    MaríaL. Manzano
        6
    Francisco GeaRodríguez
        7
    Javier Crespo
        8
    BelénPiqueras
        9
    胡安M.帕斯卡西奥
        210
    卡门Comas
        11
    玛丽亚·古铁雷斯
        12
    Alberto Aguirre
        13
    EmilioSuárez
        14
    JavierGarcía-Samaniego
        215
    Miguel Rivero
        16
    Doroteo Acero
        17
    Miguel Fernandez-Bermejo
        18
    迭戈莫雷诺
        19
    PilarSánchez-Pobre
        20
    Beatriz de Cuenca
        21
    J. Moreno-Palomares
        22
    拉斐尔·埃斯特万
        12
    玛丽亚·布蒂
        12电子作者

    1.内科医学部肝内科医生大学和巴塞罗那自治大学
    2.Centro deInvestigaciónBiomédicaen Red de EnfermedadesHepáticasy Digestivas（CIBERehd）Instituto de Salud Carlos IIIMadridSpain
    3.肝病理学单位，生物化学和微生物学部门（病毒学单位）医院大学希尔伯勒大学和巴塞罗那自治大学
    4.马德里自治大学医院
    5.肝脏单位，医院巴塞罗那
    6.消化系部门12月8日马德里西班牙
    7.Digestive Diseases Department医院大楼Ramóny Cajal马德里西班牙
    8.瓦尔迪切拉大学医学和肝脏病科，IDIVALFacultad de MedicinaSantander西班牙
    9.胃肠疾病司西班牙福冈大学
    10.希腊疾病部
    11.消化疾病司司法大学
    12.Digestive Diseases Department国立大学基金会AlcorcónAlcorcón
    13.Digestive Diseases Department医院大楼SeveroOchoaLeganés西班牙
    14.Digestive Diseases Department卫生大学
    15.拉巴斯大学医学院肝脏单位
    16.Digestive Diseases Department Hospital Universitario del SuresteArganda del ReySpain
    17.希腊省医院卫生局Dr. Josep Trueta Girona西班牙
    18.消化疾病司。圣佩德罗 - 德阿尔卡塔拉 - 西班牙
    19.希腊疾病司Mospost Universitario deMóstoles
    20.圣地亚哥医院
    21.消化系统
    22.内科司Segovia塞哥维亚

来源文章

首先在线：
    2017年1月11日

DOI：10.1007 / s10620-017-4448-7

引用本文：
    Riveiro-Barciela，M.，Tabernero，D.，Calleja，J.L.et al。 Dig Dis Sci（2017）62：784。doi：10.1007 / s10620-017-4448-7

    2股182下载

抽象
背景

长期抗病毒治疗已导致慢性乙型肝炎的病毒抑制和生化反应，虽然肝细胞癌的风险尚未消除。 Page-B评分可用于估计HCC的概率。
目标

分析恩替卡韦或替诺福韦4年以上的有效性和安全性，以及Page-B评分在现实世界环境中的有效性。
方法

分析来自前瞻性多中心数据库CIBERHEP的恩替卡韦或替诺福韦治疗的高加索慢性乙型肝炎患者。
结果

总共611名患者入选：187名接受恩替卡韦，424名替诺福韦。大多数是男性，平均年龄50岁，32％肝硬化和16.5％HBeAg阳性。平均随访55（恩替卡韦）和49（替诺福韦）月。 > 90％分别在12个月和36个月达到HBV DNA <69 IU / mL和生化正常化。累积HBeAg损失和抗HBe血清转换达到33.7和23.8％。 4例患者失去HBsAg; 3例HBeAg阳性。长期随访的肾功能保持稳定。 14例（2.29％）在随访期间发展HCC，所有患者的基线Page-B≥10。在治疗的前5年内诊断出9例。这与Page B估计的 27
差异形成了对比，后者突出了即使在病毒抑制患者中的常规HCC监测的重要性。

结论

恩替卡韦和替诺福韦实现了高生化和病毒学应答。 两种药物的肾功能保持稳定。 A-B截断值≥10选择所有有HCC发展风险的患者。

关键词肝炎BHepatocellular carcinomaPage-BTenofovirEntecavirEffectivenessSafety