AASLD2018[269]验证Easl 2017临床实践 切换HBV患者的指南标准 长期

StephenW

269
Validation of the Easl 2017 Clinical Practice
Guidelines Criteria for Switching HBV Patients
LONG-TERM Treated with Tdf to Etv or Taf
Alessandro Loglio1, Luisa Roade2, Marta Borghi1, Roberta
Soffredini1, Floriana Facchetti1, Dhanai Di Paolo1, Maria
DEL MAR Riveiro Barciela2, David Tabernero2, Giovanna
Lunghi3, Maria Buti2 and Pietro Lampertico1, (1)Division
of Gastroenterology and Hepatology, CRC “a. M. e a.
Migliavacca” Center for Liver Disease Fondazione Irccs Ca’
Granda Ospedale Maggiore Policlinico, University of Milan,
(2)Liver Unit, Hospital Universitary Valle Hebron, (3)Virology
Unit, Fondazione Irccs Ca’ Granda Ospedale Maggiore
Policlinico, University of Milan
Background: The 2017 EASL Clinical Practice Guidelines
recommend Tenofovir Alafenamide (TAF) or Entecavir
(ETV) instead of Tenofovir Disoproxil (TDF) in chronic HBV
patients older than 60 years, or with bone disease or with
renal disease. Aim of the study was to define the proportion
of CHB patients currently treated with TDF in two European
centers that should be switched to TAF to prevent or minimize
bone and renal toxicities. Methods: All consecutive chronic
HBV patients on TDF before 31 Dec 2017 were enrolled in a
cross-sectional study at the control blood sample, between
Jan and 1th May 2018. GFR was assessed by Cockcroft-Gault
formula; last spine DEXA scans, Vit D, and PTH levels were
used. Results: 565 patients were enrolled: 62 (18-91) yearsold,
92% Caucasian, 92% HBeAg negative, 77% genotype
D, 75% males, 40% cirrhotics, 33% arterial hypertension,
10% diabetes, BMI 25 (16-46) kg/m2, 95% undetectable
HBV DNA, 91% normal ALT, 53% previously exposed to
Lamivudine or Adefovir. They were treated by TDF for 96
(3-149) months, 33% on a reduced daily dose: 9% ab initio
(90% NUC-exposed) and 24% after 33 (1-103) months of
TDF (69% NUC-exposed), following a GFR decrease in 65%
and hyperphosphaturia appearance in 35%. Out of 258 NUCnaïve
subjects who started TDF 245 mg/day, 42 (16%) have
reduced dose after 38 (1-101) months due to GFR in 69%.
Over the entire enrolled population, 21% had GFR <60 mL/
min (77% already on a reduced TDF dose), 19% low serum
phosphate, 6% increased albuminuria, 6% moderate dipstick
proteinuria. 4% had Vit D <15 ng/ml, 20% elevated PTH, 13%
osteoporosis and 62% on Vit D supplementation from 49 (1-
221) months. By applying the EASL 2017 criteria, 55% were
>60 years, 17% had osteoporosis or were steroid-treated,
and 36% had renal disease. Overall, 66% had at least one
criterion, 8% all three criteria, 12% age and bone criteria and
10% bone and renal criteria. 28% met both the age and renal
criteria. Conclusion: A significant proportion of CHB patients
on long-term TDF in a real-life setting fulfills the EASL 2017
recommendations to switch to ETV or TAF. Besides, TDF
dose reductions due to renal alterations are required in many
of these patients.

StephenW

269
验证Easl 2017临床实践
切换HBV患者的指南标准
长期治疗用Tdf治疗Etv或Taf
Alessandro Loglio1，Luisa Roade2，Marta Borghi1，Roberta
Soffredini1，Floriana Facchetti1，Dhanai Di Paolo1，Maria
DEL MAR Riveiro Barciela2，David Tabernero2，Giovanna
Lunghi3，Maria Buti2和Pietro Lampertico1，（1）分部
中华人民共和国消化内科和肝病学杂志M. e。
Migliavacca“肝病中心Irccs Ca”
米兰大学Granda Ospedale Maggiore Policlinico
（2）Universle Valle Hebron医院肝脏科，（3）病毒学
Unit，Fondazione Irccs Ca'Granda Ospedale Maggiore
Policlinico，米兰大学
背景：2017年EASL临床实践指南
推荐替诺福韦阿拉芬胺（TAF）或恩替卡韦
（ETV）代替替诺福韦地索普西（TDF）治疗慢性HBV
患者年龄超过60岁，或患有骨病或患有骨病
肾病。该研究的目的是确定比例
目前在两个欧洲人中接受TDF治疗的CHB患者
应切换到TAF以防止或最小化的中心
骨和肾毒性。方法：所有连续慢性
2017年12月31日之前在TDF上接种的HBV患者入组
在对照血液样本之间的横断面研究
2018年1月和1月.GFR由Cockcroft-Gault评估
式;最后脊柱DEXA扫描，Vit D和PTH水平均为
用过的。结果：565名患者入组：62（18-91）岁，
92％高加索人，92％HBeAg阴性，77％基因型
D，75％男性，40％肝硬化，33％动脉高血压，
10％糖尿病，BMI 25（16-46）kg / m2,95％不可检测
HBV DNA，91％正常ALT，53％以前暴露于
拉米夫定或阿德福韦。他们接受TDF治疗96
（3-149）个月，每日剂量减少33％：从头算9％
（暴露于90％NUC）和33（1-103）个月后24％
随着GFR下降65％，TDF（暴露于69％NUC）
和高磷酸盐尿症的外观在35％。在58个NUCnaïve中
开始TDF 245 mg /天，42（16％）的受试者
由于GFR为69％，在38（1-101）个月后减少剂量。
在整个登记人群中，21％的GFR <60 mL /
min（已经减少TDF剂量的77％），19％的低血清
磷酸盐，白蛋白尿增加6％，中度量油尺增加6％
蛋白尿。 4％维生素D <15 ng / ml，PTH升高20％，13％
骨质疏松症和62％的维生素D补充从49（1-
221）个月。通过应用EASL 2017标准，55％是
> 60岁，17％患有骨质疏松症或经过类固醇治疗，
36％患有肾脏疾病。总体而言，66％至少有一个
标准，8％所有三个标准，12％年龄和骨骼标准和
10％的骨和肾标准。 28％符合年龄和肾脏
标准。结论：相当比例的CHB患者
在真实环境中的长期TDF实现了2017年的EASL
建议切换到ETV或TAF。此外，TDF
许多人需要因肾脏改变而导致的剂量减少
这些病人

Hepbest

  269 Validation of the Easl 2017 Clinical Practice Guidelines Criteria for Switching HBV Patients LONG-TERM Treated with Tdf to Etv or Taf Alessandro Loglio1, Luisa Roade2, Marta Borghi1, Roberta Soffredini1, Floriana Facchetti1, Dhanai Di Paolo1, Maria DEL MAR Riveiro Barciela2, David Tabernero2, Giovanna Lunghi3, Maria Buti2 and Pietro Lampertico1, (1)Division of Gastroenterology and Hepatology, CRC “a. M. e a. Migliavacca” Center for Liver Disease Fondazione Irccs Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, (2)Liver Unit, Hospital Universitary Valle Hebron, (3)Virology Unit, Fondazione Irccs Ca’ Granda Ospedale Maggiore Policlinico, University of Milan
  
  Background:
  The 2017 EASL Clinical Practice Guidelines recommend Tenofovir Alafenamide (TAF) or Entecavir (ETV) instead of Tenofovir Disoproxil (TDF) in chronic HBV patients older than 60 years, or with bone disease or with renal disease. Aim of the study was to define the proportion of CHB patients currently treated with TDF in two European centers that should be switched to TAF to prevent or minimize bone and renal toxicities.
  
  Methods:
  All consecutive chronic HBV patients on TDF before 31 Dec 2017 were enrolled in a cross-sectional study at the control blood sample, between Jan and 1th May 2018. GFR was assessed by Cockcroft-Gault formula; last spine DEXA scans, Vit D, and PTH levels were used.
  
  Results:
  565 patients were enrolled: 62 (18-91) yearsold, 92% Caucasian, 92% HBeAg negative, 77% genotype D, 75% males, 40% cirrhotics, 33% arterial hypertension, 10% diabetes, BMI 25 (16-46) kg/m2, 95% undetectable HBV DNA, 91% normal ALT, 53% previously exposed to Lamivudine or Adefovir. They were treated by TDF for 96 (3-149) months, 33% on a reduced daily dose: 9% ab initio (90% NUC-exposed) and 24% after 33 (1-103) months of TDF (69% NUC-exposed), following a GFR decrease in 65% and hyperphosphaturia appearance in 35%. Out of 258 NUCnaïve subjects who started TDF 245 mg/day, 42 (16%) have reduced dose after 38 (1-101) months due to GFR in 69%. Over the entire enrolled population, 21% had GFR <60 mL/ min (77% already on a reduced TDF dose), 19% low serum phosphate, 6% increased albuminuria, 6% moderate dipstick proteinuria. 4% had Vit D <15 ng/ml, 20% elevated PTH, 13% osteoporosis and 62% on Vit D supplementation from 49 (1- 221) months. By applying the EASL 2017 criteria, 55% were >60 years, 17% had osteoporosis or were steroid-treated, and 36% had renal disease. Overall, 66% had at least one criterion, 8% all three criteria, 12% age and bone criteria and 10% bone and renal criteria. 28% met both the age and renal criteria.
  
  Conclusion:
  A significant proportion of CHB patients on long-term TDF in a real-life setting fulfills the EASL 2017 recommendations to switch to ETV or TAF. Besides, TDF dose reductions due to renal alterations are required in many of these patients.

Hepbest

269对Easl 2017临床实践指南的验证转换HBV患者的标准长期使用Tdf治疗Etv或Taf Alessandro Loglio1，Luisa Roade2，Marta Borghi1，Roberta Soffredini1，Floriana Facchetti1，Dhanai Di Paolo1，Maria DEL MAR Riveiro Barciela2，David Tabernero2，Giovanna Lunghi3，Maria Buti2和Pietro Lampertico1，（1）CRC胃肠病学和肝病学分部“a。 M. e。 Migliavacca“米兰大学肝脏病学中心Irccs Ca'Granda Ospedale Maggiore Policlinico，（2）Universle Valle Hebron医院肝脏科，（3）米兰大学基金会医学院病毒科，Granda Ospedale Maggiore Policlinico
  
  背景：
  2017年EASL临床实践指南建议使用替诺福韦阿拉福胺（TAF）或恩替卡韦（ETV）代替替诺福韦地索普西（TDF）治疗60岁以上的慢性HBV患者，或骨病或肾病患者。该研究的目的是确定目前在两个欧洲中心接受TDF治疗的CHB患者的比例，这些患者应转为TAF以预防或减少骨和肾毒性。
  
  方法：
  2017年1月31日之前所有连续慢性HBV患者在2017年12月31日之前参加了对照血液样本的横断面研究.GFR通过Cockcroft-Gault公式评估;使用最后一次脊柱DEXA扫描，Vit D和PTH水平。
  
  结果：
  招募了565名患者：62（18-91）岁，92％高加索人，92％HBeAg阴性，77％基因型D，75％男性，40％肝硬化，33％动脉高血压，10％糖尿病，BMI 25（16-46） ）kg / m2,95％检测不到HBV DNA，91％ALT正常，53％先前暴露于拉米夫定或阿德福韦。他们接受TDF治疗96（3-149）个月，每日剂量减少33％：从头算9％（接触90％NUC）和TDF 33（1-103）个月后24％（69％NUC）随着GFR降低65％和高磷酸尿症外观降低35％。在开始TDF 245 mg /天的258名NUCnaïve受试者中，42名（16％）在38（1-101）个月后减少了剂量，因为GFR为69％。在整个登记人群中，21％的GFR <60 mL / min（已经减少TDF剂量的77％），19％的低血清磷酸盐，6％的白蛋白尿增加，6％的中度试纸蛋白尿。从49（1-21）个月开始，4％的维生素D <15 ng / ml，20％的PTH升高，13％的骨质疏松症和62％的维生素D补充剂。通过应用EASL 2017标准，55％> 60岁，17％患有骨质疏松症或进行类固醇治疗，36％患有肾病。总体而言，66％具有至少一个标准，8％全部三个标准，12％年龄和骨标准以及10％骨和肾标准。 28％符合年龄和肾脏标准。
  
  结论：
  在现实生活中，很大一部分CHB患者接受长期TDF治疗，符合2017年EASL建议，转而使用ETV或TAF。此外，许多这些患者需要因肾脏改变而导致TDF剂量减少。