恩替卡韦或替诺福韦在西班牙队列的慢性乙型肝炎患者的有

StephenW

Dig Dis Sci. 2017 Jan 11. doi: 10.1007/s10620-017-4448-7. [Epub ahead of print]
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.Riveiro-Barciela M1,2, Tabernero D2,3, Calleja JL2,4, Lens S2,5, Manzano ML6, Rodríguez FG7, Crespo J8, Piqueras B9, Pascasio JM2,10, Comas C11, Gutierrez ML12, Aguirre A13, Suárez E14, García-Samaniego J2,15, Rivero M16, Acero D17, Fernandez-Bermejo M18, Moreno D19, Sánchez-Pobre P20, de Cuenca B21, Moreno-Palomares JJ22, Esteban R1,2, Buti M23,24.
Author information

• 1Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona, Passeig Vall Hebron, 119-129, 08035, Barcelona, Spain.
• 2Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.
• 3Liver Pathology Unit, Departments of Biochemistry and Microbiology (Virology Unit), Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona, Barcelona, Spain.
• 4Liver Unit, Hospital U. Puerta de Hierro, Universidad Autonoma de Madrid, Majadahonda, Madrid, Spain.
• 5Liver Unit, Hospital Clínic de Barcelona, IDIBAPS, Barcelona, Spain.
• 6Digestive Diseases Department, Hospital Universitario 12 de octubre, Madrid, Spain.
• 7Digestive Diseases Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.
• 8Gastroenterology and Hepatology Unit, Hospital Universitario Valdecilla, IDIVAL, Facultad de Medicina, Santander, Spain.
• 9Digestive Diseases Department, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain.
• 10Digestive Diseases Department, Hospital Universitario Virgen del Rocío, Seville, Spain.
• 11Digestive Diseases Department, Hospital Universitario Infanta Sofía, San Sebastián de los Reyes, Madrid, Spain.
• 12Digestive Diseases Department, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain.
• 13Digestive Diseases Department, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain.
• 14Digestive Diseases Department, Hospital Universitario Virgen de Valme, Seville, Spain.
• 15Liver Unit, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.
• 16Digestive Diseases Department, Hospital Universitario del Sureste, Arganda del Rey, Madrid, Spain.
• 17Digestive Diseases Department, Hospital Universitario de Girona Dr. Josep Trueta, Girona, Spain.
• 18Digestive Diseases Department, Hospital San Pedro de Alcántara, Cáceres, Spain.
• 19Digestive Diseases Department, Hospital Universitario de Móstoles, Móstoles, Madrid, Spain.
• 20Digestive Diseases Department, Hospital Clínico San Carlos, Madrid, Spain.
• 21Digestive Diseases Department, Hospital Infanta Cristina, Parla, Madrid, Spain.
• 22Internal Medicine Department, Hospital General de Segovia, Segovia, Spain.
• 23Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona, Passeig Vall Hebron, 119-129, 08035, Barcelona, Spain. [email protected].
• 24Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. [email protected].
  

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.


KEYWORDS: Effectiveness; Entecavir; Hepatitis B; Hepatocellular carcinoma; Page-B; Safety; Tenofovir

PMID:28078526DOI:10.1007/s10620-017-4448-7

StephenW

Dig Dis Sci。 2017 Jan 11。doi：10.1007 / s10620-017-4448-7。 [打印前的电子版]
恩替卡韦或替诺福韦在西班牙队列的慢性乙型肝炎患者的有效性和安全性：验证的页B评分预测肝细胞癌。
Riveiro-Barciela M1,2，Tabernero D2,3，Calleja JL2,4，Lens S2,5，Manzano ML6，RodríguezFG7，Crespo J8，Piqueras B9，Pascasio JM2,10，Comas C11，Gutierrez ML12，Aguirre A13，SuárezE14 ，García-Samaniego J2,15，Rivero M16，Acero D17，Fernandez-Bermejo M18，Moreno D19，Sánchez-Pobre P20，de Cuenca B21，Moreno-Palomares JJ22，Esteban R1,2，Buti M23,24。
作者信息

    1 Liver Unit，Department of Internal Medicine，Hospital Universitari Vall d'Hebron and UniversitatAutònomade Barcelona，Passeig Vall Hebron，119-129,08035，Barcelona，Spain。
    2Centro deInvestigaciónBiomédicaen Red de EnfermedadesHepáticasy Digestivas（CIBERehd），Instituto de Salud Carlos III，Madrid，Spain。
    3肝病理学单位，生物化学和微生物学（病毒学部），医院大学希尔布伦和大学自动化巴塞罗那，巴塞罗那，西班牙。
    4Liver Unit，Hospital U.Puerta de Hierro，Universidad Autonoma de Madrid，Majadahonda，Madrid，Spain。
    5 Liver Unit，HospitalClínicde Barcelona，IDIBAPS，Barcelona，Spain。
    6 Digestive Diseases Department，Hospital Universitario 12 de octubre，Madrid，Spain。
    7西班牙马德里市医院大学医院消化系。
    8胃肠病学和肝脏病学单位，医院大学瓦尔迪切拉，IDIVAL，医学院，西班牙桑坦德。
    9 Digestive Diseases Department，Hospital Universitario de Fuenlabrada，Fuenlabrada，Madrid，Spain。
    10 Digestive Diseases Department，Hospital Universitario Virgen delRocío，Seville，Spain。
    11西班牙马德里圣塞巴斯蒂安德洛斯雷耶斯大学医院大学医院疾病系。
    12 Diigestive Diseases Department，Hospital UniversitarioFundaciónAlcorcón，Alcorcón，Madrid，Spain。
    13 Digestive Diseases Department，Hospital Universitario Severo Ochoa，Leganés，Madrid，Spain。
    14 Digestive Diseases Department，Hospital Universitario Virgen de Valme，Seville，Spain。
    15Liver Unit，Hospital Universitario La Paz，IdiPAZ，Madrid，Spain。
    16Digestive Diseases Department，Hospital Universitario del Sureste，Arganda del Rey，Madrid，Spain。
    17希罗纳大学医院消化系博士Josep Trueta博士，西班牙赫罗纳。
    西班牙卡塞雷斯，San Pedro deAlcántara医院消化疾病司。
    19 Digestive Diseases Department，Hospital Universitario deMóstoles，Móstoles，Madrid，Spain。
    20西班牙马德里圣卡洛斯医院消化疾病司。
    21西班牙马德里Parla医院Infanta克里斯蒂娜医院疾病系。
    22西班牙塞戈维亚，塞戈维亚医院内科。
    23 Liver Unit，Department of Internal Medicine，Hospital Universitari Vall d'Hebron and UniversitatAutònomade Barcelona，Passeig Vall Hebron，119-129,08035，Barcelona，Spain。 [email protected]。
    24 Centro deInvestigaciónBiomédicaen Red de EnfermedadesHepáticasy Digestivas（CIBERehd），Instituto de Salud Carlos III，Madrid，Spain。 [email protected]。

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评分可用于评估HCC的概率。
AIMS：

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白人慢性乙型肝炎患者。
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27页估计的差异形成了对比，差异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选择所有具有HCC发展风险的患者。
关键词：

有效性;恩替卡韦乙型肝炎;肝细胞癌;页面B;安全;