使用替诺福韦阿拉芬酰胺治疗亚洲慢性乙型肝炎病毒的专家

StephenW

An expert review on the use of tenofovir alafenamide for the treatment of chronic hepatitis B virus infection in Asia
Michael R Charlton  1 , Altaf Alam  2 , Akash Shukla  3 , Bekhbold Dashtseren  4 , Cosmas Rinaldi Adithya Lesmana  5 , Davadoorj Duger  6 , Diana Alcantara Payawal  7 , Do Duy Cuong  8 , Ganbolor Jargalsaikhan  9   10   11 , Ian Homer Yee Cua  12 , Jose Decena Sollano  13 , Karam Romeo Singh  14 , Kaushal Madan  15 , Khin Maung Win  16 , Khin Pyone Kyi  17 , Kyaw Soe Tun  18 , Mohd Salih  19 , Mukul Rastogi  20   21 , Neeraj Saraf  22 , Pham Thi Thu Thuy  23 , Pham Tran Dieu Hien  24 , Rino Alvani Gani  25 , Rosmawati Mohamed  26 , Tawesak Tanwandee  27 , Teerha Piratvisuth  28 , Wattana Sukeepaisarnjaroen  29 , Win Naing  30 , Zahid Yasin Hashmi  31
Affiliations
Affiliations

    1
    Transplant Institute, Center for Liver Diseases, University of Chicago Biological Sciences, 5841 South Maryland Avenue, Chicago, Illinois, USA. [email protected].
    2
    GI Hepatology, Lahore, Pakistan.
    3
    Department of Gastroenterology, LTM Medical College and Sion Hospital, Maharashtra, Mumbai, India.
    4
    Liver Center Hospital, Ulaanbaatar, Mongolia.
    5
    Department of Internal Medicine, Hepatobiliary Division, Dr. Cipto Mangunkusumo Hospital, Universitas Indonesia, Jakarta, Indonesia.
    6
    Mongolian National University of Medical Sciences, Ulaanbaatar, Mongolia.
    7
    Department of Medicine, Cardinal Santos Medical Center, Mandaluyong, Metro, Manila, Philippines.
    8
    Department of Infectious Diseases and HIV Outpatient Clinic, Bach Mai Hospital, Hanoi, Vietnam.
    9
    Department Liver Center, Ulaanbaatar, Mongolia.
    10
    Department International Graduate Program in Medicine (IGPM) Institution, Ulaanbaatar, Mongolia.
    11
    College of Medicine, Taipei Medical University, Taipei, Taiwan.
    12
    Research Committee and Social Committee, Institute of Digestive and Liver Diseases, St. Luke's Medical Center, Taguig, Philippines.
    13
    Department of Medicine, University of Santo Tomas Hospital, Manila, Philippines.
    14
    Liver Clinic, Regional Institute of Sciences, Imphal, India.
    15
    Gastroenterology & Hepatology, Max Smart Super Speciality Hospital, Saket, New Delhi, India.
    16
    University of Medicine (1) YGN, Yangon, Myanmar.
    17
    Myanmar Liver Foundation, Liver Foundation, Yangon, Myanmar.
    18
    Myanmar GI and Liver Society, Yangon, Myanmar.
    19
    Department of Hepatology, Quaid e Azam International Hospital, Islamabad, Pakistan.
    20
    Department of Hepatology and Gastroenterology, Fortis Hospital, Noida, India.
    21
    Department of Transplant Hepatology, Fortis Hospital, Noida, India.
    22
    Clinical/Transplant Hepatology Institute of Digestive and Hepatobiliary Sciences Medanta, The Medicity, Gurgaon, New Delhi, India.
    23
    Department of Medic Medical Center, Ho Chi Minh City, Vietnam.
    24
    Department of Infectious Disease, Pham Ngoc Thach University of Medicine, Ho Chi Minh, Vietnam.
    25
    Liver Transplantation team, Ciptomangunkusumo Hospital, Jakarta, Indonesia.
    26
    Department of Medicine, University Malaya Medical Centre, Kuala Lumpur, Malaysia.
    27
    Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
    28
    Department of Medicine, NKC Institute of Gastroenterology and Hepatology, Songklanagarind Hospital, Prince of Songkla University, Hat Yai, Thailand.
    29
    Gastroenterology Unit, Department of Medicine, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
    30
    Department of Hepatology, Yangon General Hospital, University of Medicine (1), Yangon, Myanmar.
    31
    PMC, Allied and DHQ Hospital, Faisalabad, Pakistan.

    PMID: 32666200 DOI: 10.1007/s00535-020-01698-4

Abstract

Asia has intermediate-to-high prevalence and high morbidity of hepatitis B virus (HBV) infection. The use of guideline-recommended nucleos(t)ide analogs with high barrier to resistance, such as entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF), is one of the key interventions for curbing HBV infection and associated morbidity in Asia. However, there are some challenges to the use of ETV and TDF; while ETV is associated with high resistance in lamivudine (LAM)-exposed (especially LAM-refractory) patients; bone and renal safety issues are a major concern with TDF. Hence, a panel of twenty-eight expert hepatologists from Asia convened, reviewed the literature, and developed the current expert opinion-based review article for the use of TAF in the resource-constrained settings in Asia. This article provides a comprehensive review of two large, phase 3, double-blind, randomized controlled trials of TAF versus TDF in HBeAg-negative (study 0108) and HBeAg-positive (study 0110) chronic HBV patients (> 70% Asians). These studies revealed as follows: (1) non-inferiority for the proportion of patients who had HBV DNA < 29 IU/mL; (2) significantly high rate of normalization of alanine aminotransferase levels; (3) no incidence of resistance; and (4) significantly better bone and renal safety, with TAF vs. TDF up to 144 weeks. Considering the benefits of TAF, the expert panel proposed recommendations for optimizing the use of TAF in Asia, along with guidance on specific patient groups at risk of renal or bone disease suitable for TAF therapy. The guidance provided in this article may help clinicians optimize the use of TAF in Asia.

Keywords: Asia; Hepatitis B virus; Nucleoside analogs; Tenofovir alafenamide.

StephenW

使用替诺福韦阿拉芬酰胺治疗亚洲慢性乙型肝炎病毒的专家评论
Michael R Charlton 1，Altaf Alam 2，Akash Shukla 3，Bekhbold Dashtseren 4，Cosmas Rinaldi Adithya Lesmana 5，Davadoorj Duger 6，Diana Alcantara Payawal 7，Do Duy Cuong 8，Ganbolor Jargalsaikhan 9 10 11，Ian Homer Yee Cua 12，Jose Decena Sollano 13，Karam Romeo Singh 14，Kaushal Madan 15，Khin Maung Win 16，Khin Pyone Kyi 17，Kyaw Soe Tun 18，Mohd Salih 19，Mukul Rastogi 20 21，Neeraj Saraf 22，Pham Thi Thu Thuy 23，Pham Tran Dieu Hien 24，Rino Alvani Gani 25，Rosmawati Mohamed 26，Tawesak Tanwandee 27，Teerha Piratvisuth 28，Wattana Sukeepaisarnjaroen 29，Win Naing 30，Zahid Yasin Hashmi 31
隶属关系
隶属关系

    1个
    芝加哥大学生物科学中心肝病移植研究所，美国伊利诺伊州芝加哥南马里兰大道5841号。 [email protected]。
    2
    巴基斯坦拉合尔胃肠道肝病学。
    3
    印度孟买马哈拉施特拉邦LTM医学院和Sion医院消化内科。
    4
    蒙古乌兰巴托肝脏中心医院。
    5
    印度尼西亚雅加达大学印尼大学Cipto Mangunkusumo医院肝胆科内科。
    6
    蒙古国立医科大学，蒙古乌兰巴托。
    7
    菲律宾马尼拉大都会曼达卢永市红衣主教桑托斯医学中心医学系。
    8
    越南河内巴赫迈医院传染病和艾滋病门诊部。
    9
    蒙古乌兰巴托部门肝脏中心。
    10
    蒙古乌兰巴托，医学系国际研究生课程（IGPM）机构。
    11
    台北医科大学医学院，台湾台北。
    12
    菲律宾塔吉格圣卢克医学中心消化与肝病研究所研究委员会和社会委员会。
    13
    菲律宾马尼拉圣托马斯大学医院医学系。
    14
    印度因帕尔地区科学研究所肝脏诊所。
    15
    印度新德里萨克特马克斯·斯玛特超级专科医院消化内科和肝病科。
    16
    缅甸仰光医学院（1）YGN。
    17
    缅甸肝脏基金会，肝脏基金会，仰光，缅甸。
    18
    缅甸地理标志和肝脏协会，仰光，缅甸。
    19
    巴基斯坦伊斯兰堡，Quaid e Azam国际医院肝病科。
    20
    印度诺伊达，富通医院肝病和肠胃病科。
    21
    印度诺伊达富通医院移植肝科。
    22
    印度新德里古尔冈市Medicity Medanta消化与肝胆科学研究所/移植肝病研究所。
    23
    越南胡志明市医疗中心。
    24
    范胡萨奇医科大学传染病系，越南胡志明市。
    25
    印度尼西亚雅加达Ciptomangunkusumo医院肝移植小组。
    26
    马来西亚吉隆坡马来亚大学医学中心医学系。
    27
    泰国曼谷玛希顿大学西里拉吉医院医学部消化内科。
    28岁
    泰国合艾王子府宋卡大学宋卡兰加林医院NKC胃肠病和肝病研究所医学系。
    29
    孔敬大学医学院Srinagarind医院医学部消化内科，泰国孔敬。
    30
    缅甸仰光，医学院大学仰光总医院肝病科（1）。
    31
    巴基斯坦费萨拉巴德联合医院和DHQ医院PMC。

    PMID：32666200 DOI：10.1007 / s00535-020-01698-4

抽象

亚洲的乙型肝炎病毒（HBV）感染率处于中到高的发病率和高发病率。使用抗药性高的指南推荐的核苷酸类似物，例如恩替卡韦（ETV），替诺福韦二吡呋酯富马酸酯（TDF）和替诺福韦阿拉芬酰胺（TAF），是遏制HBV感染的关键干预措施之一，亚洲的相关发病率。但是，使用ETV和TDF面临一些挑战。拉美夫定（LAM）暴露（尤其是LAM难治性）患者的ETV与高耐药性相关；骨和肾脏安全问题是TDF的主要关注点。因此，由来自亚洲的28位专家肝病专家组成的小组召集，审查了文献，并撰写了当前基于专家意见的评论文章，供在亚洲资源有限的地区使用TAF。本文对HBeAg阴性（研究0108）和HBeAg阳性（研究0110）的慢性HBV患者（> 70％亚洲人）中的TAF与TDF进行的两项大型，三阶段，双盲，随机对照试验进行了全面回顾。这些研究表明：（1）HBV DNA <29 IU / mL的患者的比例不逊色； （2）丙氨酸氨基转移酶水平的正常化率极高； （3）无耐药性发生； （4）在144周内，TAF与TDF相比，明显改善了骨骼和肾脏的安全性。考虑到TAF的益处，专家小组提出了在亚洲优化TAF使用的建议，并针对有可能患TAF治疗的有肾病或骨病风险的特定患者群体提供了指导。本文提供的指南可帮助临床医生在亚洲优化TAF的使用。

关键词：亚洲；乙型肝炎病毒;核苷类似物；替诺福韦阿拉芬酰胺。

StephenW

https://link.springer.com/conten ... 535-020-01698-4.pdf