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Review of the pharmacological management of hepatitis B viral infection before and after liver transplantation

World Journal of Gastroenterology 2013年第48期19卷 9189-9197页

作者： Evangelos Cholongitas George V Papatheodoridis Department of Internal Medicine Medical School of Aristotle University Hippokration General Hospital of Thessaloniki 54642 Thessaloniki Greece George V Papatheodoridis Department of GastroenterologyAthens University Medical School Laiko General Hospital of Athens 11527 Athens Greece

The progress in treatment against hepatitis B virus(HBV)with the development of effective and well tolerated nucleotide analogues(NAs)has improved the outcome of patients with HBV decompensated cirrhosis and has prevented post-transplant HBV *** review summarizes updated issues related to the management of patients with HBV infection before and after liver transplantation(LT).A literature search using the PubMed/Medline databases and consensus documents was ***-transplant therapy has been initially based on lamivudine,but entecavir and tenofovir represent the currently recommended first-line NAs for the treatment of patients with HBV decompensated *** LT,the combination of HBV immunoglobulin(HBIG)and NA is considered as the standard of care for prophylaxis against HBV *** combination of HBIG and lamivudine is related to higher rates of HBV recurrence,compared to the HBIG and entecavir or tenofovir *** HBIG-free prophylactic regimens,entecavir and tenofovir should be the first-line *** choice of treatment for HBV recurrence depends on prior prophylactic therapy,but entecavir and tenofovir seem to be the most attractive ***,liver grafts from hepatitis B core antibody(anti-HBc)positive donors can be safely used in hepatitis B surface antigen negative,preferentially anti-HBc/anti-hepatitis B surface antibody positive recipients.

关键词： Hepatitis B virus Liver transplantation Hepatitis B virus immunoglobulin Antivirals Lamivudine adefovir Entecavir Tenofovir Telbivudine Resistance

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Chronic hepatitis B in 2014: Great therapeutic progress, large diagnostic deficit

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World Journal of Gastroenterology 2014年第33期20卷 11595-11617页

作者： Claus Niederau Katholisches Klinikum Oberhausen GmbH St. Josef Hospital Klinik für Innere Medizin Akademisches Lehr-krankenhaus der Universit?t Duisburg-Essen 46045 Oberhausen Germany

This review analyzes progress and limitations of diagnosis, screening, and therapy of patients with chronic hepatitis B infection. A literature review was carried out by framing the study questions. Vaccination in early childhood has been introduced in most countries and reduces the infection rate. Treatment of chronic hepatitis B can control viral replication in most patients today. It reduces risks for progression and may reverse liver fibrosis. The treatment effect on development of hepatocellular carcinoma is less pronounced when cirrhosis is already present. Despite the success of vaccination and therapy chronic hepatitis B remains a problem since many infected patients do not know of their disease. Although all guidelines recommend screening in high risk groups such as migrants, these suggestions have not been implemented. In addition, the performance of hepatocellular cancer surveillance under real-life conditions is poor. The majority of people with chronic hepatitis B live in resource-constrained settings where effective drugs are not available. Despite the success of vaccination and therapy chronic hepatitis B infection remains a major problem since many patients do not know of their disease. The problems in diagnosis andscreening may be overcome by raising awareness, promoting partnerships, and mobilizing resources.

关键词： Chronic hepatitis B HBsAg Screening Liv-er cirrhosis Hepatocellular cancer Entecavir Tenofovi Telbivudine adefovir Lamivudine Interferon

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Choice of drugs in the treatment of chronic hepatitis B in pregnancy

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World Journal of Gastroenterology 2013年第10期19卷 1671-1672页

作者： Ertugrul Guclu Oguz Karabay Department of Infectious Diseases and Clinical Microbiology Sakarya University Faculty of Medicine54200 SakaryaTurkey

The selection of antiviral drugs for chronic hepatitis B(CHB) treatment in pregnancy is very difficult since none of the drugs have been approved for use in *** from mother to newborn remains the most frequent route of infection in mothers with high viral load and positive hepatitis B e antigen status,even with the use of appropriate prophylaxis with hepatitis B virus(HBV) immunoglobulin and HBV *** read from the article written by Yi et al that lamivudine treatment in early pregnancy was safe and ***,we could not understand why adefovir dipivoxil(ADV) was used in three pregnancy cases,since ADV has been classified as pregnancy category *** pregnancy,telbivudine or tenofovir should be selected when the treatment of CHB is necessary,since these drugs have been classified as Food and Drug Administration pregnancy risk category B.

关键词： Pregnancy adefovir dipivoxil Lamivudine Tenofovir Entecavir Chronic hepatitis B Treatment

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Efficacy of combined therapy in patients with hepatitis B virus-related decompensated cirrhosis

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World Journal of Gastroenterology 2013年第22期19卷 3481-3486页

作者： Guo-Cai Lv Jin-Mei Yao Yi-Da Yang Lin Zheng Ji-Fang Sheng Yu Chen Lan-Juan Li Clinical Laboratory First Affiliated Hospital of Zhejiang University School of Medicine State Key Laboratory for Diagnosis and Treatment of Infectious Diseases First Affiliated Hospital of Zhejiang University School of Medicine

AIM: To investigate the efficacy and safety of combined de novo lamivudine (LAM) and adefovir dipivoxil (ADV) therapy in hepatitis B virus (HBV)-related decompensated liver cirrhosis patients. METHODS: One hundred and forty patients with HBVrelated decompensated cirrhosis were recruited, 70 patients were treated with combined LAM and ADV de novo therapy, and the other 70 patients were treated with LAM alone as controls. The follow-up period was 144 wk. All patients with LAM resistance were shifted to ADV. RESULTS: The percentage of HBV-related decompensated cirrhosis patients with undetectable HBV DNA inde novo combination group was 51.6% (33/64), 84.2% (48/57), and 92.3% (49/53) by weeks 48, 96, and 144, respectively. In monotherapy group, HBV DNA negativity rate was 46.1% (30/65), 56.1% (32/57), and 39.2% (20/51) by weeks 48, 96 and 144, respectively. There was a significant difference between the two groups by weeks 96 and 144 (P = 0.012 and 0.001). The hepatitis B e antigen seroconversion rate was 28.1% (9/32), 40.0% (12/30), and 53.6% (15/28) in the combination group by weeks 48, 96 and 144, respectively, and 24.2% (8/33), 31.0% (9/29), and 37.0% (10/27) by weeks 48, 96 and 144, respectively, in monotherapy group. A total of 68.6% (44/64), 84.2% (48/57), and 92.5% (49/53) patients achieved alanine aminotransferase (ALT) normalization by weeks 48, 96 and 144, respectively in the combination group. In monotherpy group, the ALT normalization rate was 64.6% (42/65) by week 48, 73.7% (42/57) by week 96, and 80.4% (41/51) by week 144. No patients in the combination group exhibited detectable resistance for at least 144 wk. The cumulative resistance rate in monotherapy group at weeks 48, 96, and 144 was 20.0%, 36.8%, and 56.9%. Both combination group and monotherapy group demonstrated an improvement in Child-Turcotte Pugh and Model for End-Stage Liver Disease scores at weeks 48, 96, and 144. All patients tolerated both combination and monotherapy. The ceratinine level

关键词： Liver cirrhosis Lamivudine adefovir dipivoxil Efficacy Alanine transaminase

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Current therapy with nucleoside/nucleotide analogs for patients with chronic hepatitis B

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Hepatobiliary & Pancreatic Diseases International 2006年第3期5卷 350-359页

作者： Xiao-Wei Xu and Ya-Gang Chen Department of Infectious Diseases, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China Department of Infectious Diseases First Affiliated Hospital Zhejiang University School of Medicine Hangzhou 310006 China.

BACKGROUND: Currently, more and more nucleos(t)ide analogs are appearing as therapeutic options in the treatment of chronic hepatitis B (CHB). Their efficacy and safety profile in hepatitis B virus (HBV) infection have already been studied in detail worldwide. This review summarizes the efficacy of lamivudine, adefovir, entecavir and newer antiviral agents such as emtricitabine, telbivudine and clevudine in the treatment of hepatitis B in different clinical situations. DATA SOURCES: An English-language literature search using OVID and MEDLINE was performed and a total of 40 articles on the treatment of chronic hepatitis with nucleos(t)ide analogues were selected. RESULTS: Nucleos(t)ide analogs such as lamivudine, adefovir and entecavir are well tolerated and induce a decrease in serum HBV-DNA levels associated with normalization of serum alanine aminotransferase (ALT) levels. But their sustained response with HBeAg to anti-HBe seroconversion is rarely obtained and HBsAg loss is exceptional. The response is maintained during therapy which needs to be continued indefinitely in the majority of patients since withdrawal of treatment is generally followed by a rapid reactivation of hepatitis B. However, drug resistant mutations can be induced in long-term treatment. Other newer antiviral agents such as emtricitabine, telbivudine and clevudine in the treatment of hepatitis B are still under phaseⅡorⅢclinical trials. CONCLUSIONS: Nucleos(t)ide analogs play an important role in the therapy of hepatitis B now and in the future. Lamivudine is limited by the frequent emergence of drugresistant (HBV) mutants (YMDD). adefovir and entecavir appear to be effective against both YMDD mutation and wild type. Therapeutic options against hepatitis B virus remain a major clinical challenge.

关键词： hepatitis B antivirus lamivudine adefovir entecavir emtricitabine telbivudine clevudine

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Adverse effects of oral antiviral therapy in chronic hepatitis B

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World Journal of Hepatology 2017年第5期9卷 227-241页

作者： Bircan Kayaaslan Rahmet Guner Department of Infectious Disease and Clinical Microbiology Yildirim Beyazit University Faculty of MedicineAtaturk Education and Research Hospital06800 AnkaraTurkey

Oral nucleoside/nucleotide analogues(NAs) are currently the backbone of chronic hepatitis B(CHB) infection treatment. They are generally well-tolerated by patients and safe to use. To date, a significant number of patients have been treated with NAs. Safety data has accumulated over the years. The aim of this article is to review and update the adverse effects of oral NAs. NAs can cause class adverse effects(i.e., myopathy, neuropathy, lactic acidosis) and dissimilar adverse effects. All NAs carry a "Black Box" warning because of the potential risk for mitochondrial dysfunction. However, these adverse effects are rarely reported. The majority of cases are associated with lamivudine and telbivudine. adefovir can lead to dose- and time-dependent nephrotoxicity, even at low doses. Tenofovir has significant renal and bone toxicity in patients with human immunodeficiency virus(HIV) infection. However, bone and renal toxicity in patients with CHB are not as prominent as in HIV infection. Entecavir and lamivudine are not generally associated with renal adverse events. Entecavir has been claimed to increase the risk of lactic acidosis in decompensated liver disease and high Model for End-Stage Liver Disease scores. However, current studies reported that entecavir could be safely used in decompensated cirrhosis. An increase in fetal adverse events has not been reported with lamivudine, telbivudine and tenofovir use in pregnant women, while there is no adequate data regarding entecavir and adefovir. Further long-term experience is required to highlight the adverse effects of NAs, especially in special patient populations, including pregnant women, elderly and patients with renal impairment.

关键词： Nucleoside/nucleotide analogues Adverse events Lamivudine Chronic hepatitis B Side effects Safety Telbivudine Hepatitis B infection adefovir Entecavir Adverse effects Tenofovir Hepatitis B virus

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Risk for hepatocellular carcinoma in the course of chronic hepatitis B virus infection and the protective effect of therapy with nucleos(t)ide analogues

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World Journal of Hepatology 2015年第8期7卷 1064-1073页

作者： Irene Rapti Stephanos Hadziyannis Liver Unit and its Molecular Biology Laboratory National and Kapodistrian University of Athens Evgenidion Hospital of Athens Athens Medical Center National and Kapodistrian University of Athens Evgenidion Hospital of Athens

Hepatocellular carcinoma(HCC) is a major health problem worldwide, representing one of the leading causes of death. Chronic hepatitis B virus(HBV) infection(CHB) is the most important etiologic factor of this tumor, accounting for the development of more than50% of the cases in the world. Primary prevention ofHCC is possible by hepatitis B vaccination conferring protection from HBV infection. However, according to the World Health Organization Hepatitis B Fact sheet N° 204(update of July 2014) globally there exists a large pool of > 240 million people chronically infected with HBV who are at risk for development of HCC. These individuals represent a target population for secondary prevention both of cirrhosis and of HCC. Since ongoing HBV replication in CHB is linked with the progression of the underlying liver disease to cirrhosis as well as with the development of HCC, effective antiviral treatment in CHB has also been evaluated in terms of secondary prevention of HCC. Currently, most patients with active CHB are subjected to long term treatment with the first line nucleos(t)ide analogues entecavir and tenofovir. These compounds are of high antiviral potency and have a high barrier to HBV resistance compared to lamivudine, adefovir dipivoxil and even telbivudine. Many studies have shown that patients under antiviral treatment, especially those in virological remission, develop less frequently HCC compared to the untreated ones. However, the risk for development of HCC cannot be eliminated. Therefore, surveillance for the development of HCC of patients with chronic hepatitis B must be lifelong or until a time in the future when new treatments will be able to completely eradicate HBV from the liver particularly in the early stages of CHB infection. In this context, the aim of this review is to outline the magnitude of the risk for development of HCC among patients with CHB, in the various phases of the infection and in relation to virus, host and environmental facto

关键词： Chronic hepatitis B Cirrhosis Hepatocellular carcinoma Hepatitis B virus Treatment Interferon Lamivudine adefovir Entecavir Tenofovir Virological remission Nucleos(t)ide analogues

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Effect of antiviral treatment on the risk of hepatocellular carcinoma in patients with chronic hepatitis B

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World Journal of Hepatology 2010年第3期2卷 91-93页

作者： Konstantinos Tziomalos First Propedeutic Department of Internal Medicine Medical School Aristotle University of Thessaloniki AHEPA Hospital

Chronic hepatitis B (CHB) is a major risk factor for hepatocellular carcinoma (HCC). The prevention of HCC is of paramount importance in patients with CHB, particularly in those with cirrhosis. Antiviral treatment can potentially reduce the risk for HCC since it suppresses viral replication, induces HBeAg seroconversion and improves liver histology. However, most evidence supporting a protective effect of antiviral treatment originates from non-randomized or retrospective studies and is limited to conventional interferon and lamivudine. There is a paucity of data on the effects of pegylated interferon and "newer" oral agents (telbivudine, tenofovir, entecavir) on HCC risk. However, it should be emphasized that the existing randomized control studies in patients with CHB were relatively short-term and not designed to assess the effects of antiviral treatment on HCC risk. Since viral load directly correlates with HCC risk, it is reasonable to hypothesize that the reduction in viral load with antiviral treatment will also lower the risk of HCC. This benefit might become more readily apparent with the newer agents used in the management of CHB which are more effective and have a more favorable resistance profile.

关键词： Chronic hepatitis B Hepatocellular carcinoma Interferon Lamivudine adefovir Telbivudine Entecavir Tenofovir

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阿德福韦在预防肝移植后乙肝复发中的应用

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中华肝胆外科杂志 2006年第5期12卷 313-315页

作者：张雅敏朱志军郑虹邓永林蒋文涛蔡金贞沈中阳天津第一中心医院器官移植中心天津市300192

目的评价adefovir在预防肝移植后乙肝复发中的应用效果及安全性.方法统计30例应用lamivudine出现耐药及病毒变异的肝移植病例加用adefovir后病人：ALT、HBV-DNA、Cr以及HBeAg的变化,以及观察adefovir的副作用.结果应用adefovir12周后,AL... 详细信息

目的评价adefovir在预防肝移植后乙肝复发中的应用效果及安全性.方法统计30例应用lamivudine出现耐药及病毒变异的肝移植病例加用adefovir后病人：ALT、HBV-DNA、Cr以及HBeAg的变化,以及观察adefovir的副作用.结果应用adefovir12周后,ALT恢复正常者占65.5%,HBVDNA转阴（＜10^4拷贝/ml）占76.7%,HBeAg转阴44%,未发现严重的肾功能异常及其它副作用.结论肝移植术后应用lamivudine出现耐药及病毒变异病例,及时加用adefovir可有效改善肝功能、抑制肝炎复发.

关键词：肝移植 adefovir 乙肝复发

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慢性乙型肝炎患者阿德福韦酯治疗出现病毒学突破的耐药分析

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中华实验和临床感染病杂志（电子版） 2014年第3期8卷 94-97页

作者：杨松邢卉春王琦王笑梅欧蔚妮段英李贲李玥刘顺爱成军首都医科大学附属北京地坛医院肝病中心北京100015 首都医科大学附属北京地坛医院传染病研究所北京100015

目的明确临床实际工作中阿德福韦酯(ADV)治疗出现病毒学突破患者基因型耐药情况并对耐药相关因素进行分析。方法收集ADV治疗出现病毒学突破患者的血清样本及临床资料,应用PCR产物直接测序法联合焦磷酸测序法进行基因型耐药检测;分析基... 详细信息

目的明确临床实际工作中阿德福韦酯(ADV)治疗出现病毒学突破患者基因型耐药情况并对耐药相关因素进行分析。方法收集ADV治疗出现病毒学突破患者的血清样本及临床资料,应用PCR产物直接测序法联合焦磷酸测序法进行基因型耐药检测;分析基因型耐药与患者抗病毒治疗经过、基线HBV DNA载量等因素的相关性;并进一步分析rtA181T变异患者的病毒学及生化学指标变化。结果共收集106例ADV治疗出现病毒学突破患者,共检出基因型耐药45例,耐药位点67个;既往LAM等经治换用ADV患者ADV耐药检出率显著高于ADV初治患者(χ2=6.584,P=0.010);rtA181T耐药变异患者HBV DNA较最低值升高水平显著高于不包含rtA181T变异患者(t=566.000,P=0.014);包含rtA181T变异患者生化学突破率显著高于不包含rtA181T变异患者(χ2=5.140,P=0.023)。结论本组患者数据提示ADV治疗出现病毒学突破患者基因型耐药发生率约为40%,rtA181位点变异多于rtN236位点变异,rtA181T变异虽抑制耐药株病毒复制,但导致患者出现生化学突破几率并未减少。

关键词：阿德福韦酯耐药肝炎,乙型,慢性焦磷酸测序 adefovir dipivoxil (ADV)

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