替比夫定与拉米夫定治疗慢性乙型肝炎的临床观察

目的探讨替比夫定和拉米夫定治疗慢性乙型肝炎的疗效和不良反应。方法采用1：1随机、对照设计。共纳入慢性乙型肝炎患者120例,其中HBeAg阳性和阴性各60例,各组分为替比夫定组和拉米夫定组各30例。分别口服替比夫定600mg,1次／d,拉米夫定100mg,1次／d,共52周。观察比较两组临床疗效及不良反应,并动态监测患者血清HBsAg、HBeAg水平的变化。结果治疗52周时,HBeAg阳性和阴性患者中,替比夫定组血清HBVDNA自基线下降水平、HBVDNA低于检测下限的比率、病毒反跳率和耐药率,均优于拉米夫定组（均P〈0．05）。HBeAg阳性患者中替比夫定组HBeAg阴转率和治疗应答反应率高于拉米夫定组（均P〈0．05）;两组不良反应差异无统计学意义（P〉0．05）。结论替比夫定治疗慢性乙型肝炎的疗效优于拉米夫定,患者对替比夫定的耐受性较好。     

替比夫定与拉米夫定长期治疗慢性乙型肝炎的安全性评价

目的评价替比夫定与拉米夫定长期治疗慢性乙型肝炎的疗效及安全性。方法 2011年2月至2012年2月符合入选39例慢性乙型肝炎患者,分为替比夫定组25例,拉米夫定组25例观察两组临床疗效及安全性。结果替比夫定组完全应答率明显比拉米夫定组更佳,P<0.05,差异有统计学意义;替比夫定组肌酸激酶升高发生率24%,拉米夫定组肌酸激酶升高发生率6%,P<0.05,具有统计学意义。结论替比夫定临床治疗慢性乙型肝炎疗效确切,不良反应少,是一种较为安全的抗乙型肝炎病毒临床药物,可用于一线治疗。     

替比夫定治疗对阿德福韦酯应答不佳慢性乙型肝炎患者的效果观察

目的评价替比夫定对阿德福韦酯疗效不佳的慢性乙型肝炎患者的疗效。方法将本院收治的62例阿德福韦酯疗效欠佳慢性乙型肝炎患者随机分成两组,对照组32例采用替比夫定治疗;观察组30例采用替比夫定联合阿德福韦酯方案治疗。分别于治疗后第3、6个月比较两组间ALT复常率、HbeAg/HBeAb血清转换率、HBV-DNA转阴率差异及应答率差异。结果用药后两组均具有一定的ALT复常率、HbeAg/HBeAb血清转换率、HBV-DNA转阴率,但第6个月观察组的各项指标显著优于对照组;两者均具有较高的应答率,观察组完全应答率显著高于对照组。结论替比夫定对阿德福韦酯应答不佳慢性乙型肝炎患者具有较好的疗效,但其与阿德福韦酯联用的疗效更为理想。     

替比夫定与拉米夫定长期治疗慢性乙型肝炎患者疗效与安全性的随机对照研究

目的：比较替比夫定与拉米夫定长期治疗慢性乙型肝炎患者的疗效及安全性。方法：2004年3月至2005年2月符合入选标准的39例慢性乙型肝炎患者纳入研究。39例患者随机分为2组进入双盲治疗：替比夫定组（22例）,男18例,女4例,平均年龄（30.9±7.8）岁,口服替比夫定600mg,1次/d,治疗104周;拉米夫定组（17例）,男13例,女4例,平均年龄（30.4±8.5）岁,口服拉米夫定100mg,1次/d,治疗104周。104周后2组患者均进入替比夫定开放治疗,口服替比夫定600mg,1次/d,继续治疗104周。每8周检测患者血清HBV DNA水平、完全应答率和ALT水平,观察2组患者治疗104周后HBeAg血清转换情况、治疗期间病毒学反弹率及替比夫定的不良反应。结果：双盲治疗阶段,替比夫定组和拉米夫定组患者治疗52周和104周时HBV DNA的完全应答率分别为72.2%（16/22）、77.3%（17/22）和47.1%（8/17）、47.1%（8/17）;ALT的复常率分别为100%（22/22）、86.4%（19/22）和82.3%（14/17）、76.5%（13/17）。替比夫定组治疗60周、104周和第3年HBV DNA反弹率分别为4.5%（1/22）、18.2%（4/22）和28.6%（6/21）,第4年未增加反弹的病例;拉米夫定组治疗52周、104周HBV DNA的反弹率分别为23.5%（4/17）和41.2%（7/17）。2组共有4例耐药者加用阿德福韦酯联合治疗8～24周后HBV DNA下降至可检测值下限。双盲治疗阶段替比夫定组有5例患者发生9例次肌酸激酶（CK）升高（1065～4915U/L）,但无肌肉症状;开放治疗阶段有6例患者发生9例次CK升高（1036～45984U/L）,均出现肌肉症状。结论：替比夫定对慢性乙型肝炎患者的疗效优于拉米夫定;患者对替比夫定的耐受性较好。     

替比夫定联合用药治疗HBeAg阳性慢性乙型肝炎的疗效观察

我国约有1.2亿人感染乙型肝炎病毒,其中慢性乙型肝炎（chronic hepatitis B,CHB）患者约3000万,每年有相当部分患者转化为肝硬化或肝癌,抗病毒治疗可控制CHB发作,自拉米夫定治疗慢性乙型肝炎以来,出现对拉米夫定耐药的病例逐渐增多,而替比夫定作为一种新型有效的核苷类抗病毒药物,其用药的安全性和耐药性较拉米夫定好。为此,我院于2006年10月开始应用替比夫定联合用药治疗HBeAg阳性慢性乙型肝炎90例,效果满意,现将结果报告如下。     

替比夫定抗病毒研究进展

性乙型肝炎严重影响着我国人民的健康,对于肝炎无特效治疗药物和方法 ,核苷类药物的发现为乙肝患者带来了光明。研究证实对于慢性乙型肝炎患者抗病毒治疗是最根本的也是基本的治疗方法。抗病毒药物主要包括两大类：干扰素类和核苷（酸）类似物[1]。目前该类药物在国内有拉米夫定（LAM）、阿德福韦酯（ADV）、替比夫定（LdT）和恩替卡韦（ETV）。     

4种核苷类似物治疗慢性乙型肝炎的成本-效果分析

目的 对拉米夫定(LAM)、阿德福韦酯(ADV)、恩替卡韦(ETV)和替比夫定(LdT)等4种药物治疗慢性乙型肝炎进行成本 效果分析,找出最佳方案. 方法 慢性乙型肝炎患者280例,分成4组. LAM组79例,给予拉米夫定100 mg,po,qd;ADV组63例,给予阿德福韦酯10 mg,po,qd;ETV组83例,给予恩替卡韦0.5 mg,po,qd;LdT组55例,给予替比夫定600 mg,po,qd. 4组均连续用药48周. 运用药物经济学成本-效果分析法对4种核苷类似物治疗慢性乙型肝炎的治疗方案进行回顾性分析评价. 结果 治疗48周后,4种方案的总有效率分别为49.37%,36.51%,80.72%,67.27%. 成本-效果值分别为103.98,185.51,159.37,118.66,△C/△E分别为-127.47,246.58,159.15. 结论 拉米夫定治疗慢性乙型肝炎成本-效果较佳.     

替比夫定联合阿德福韦酯治疗慢性乙型肝炎的临床观察

目的：探讨替比夫定联合阿德福韦酯治疗慢性乙型肝炎的疗效。方法选择2O1O 年3月-2O12年3月于本院就诊的 HBsAg 阳性慢性乙型肝炎患者75例,将其随机分为两组。对照组35例患者采用替比夫定1OOmg/ d 治疗,研究组4O 例患者采用替比夫定联合阿德福韦酯治疗。分别观察治疗12、24、36、48周后 HBsAg 转阴率和肝功能等各项指标。结果两组患者治疗后12、24周,HBV - DNA 与 HBsAg 转阴例数比较,差异无统计学意义（ P 〉O. O5）,治疗后36、48周两组比较差异有统计学意义（P 〈 O. O5）。两组患者治疗前 AST、ALT、总胆红素（TBIL）、HBV - DNA 比差异无统计学意义（P〉 O. O5）,治疗后研究组小于对照组,差异有统计学意义（P 〈 O. O5）。结论替比夫定与阿德福韦酯联合使用治疗慢性乙型肝炎疗效优于单用替比夫定,适宜临床推广。     

替比夫定治疗HBeAg阳性慢性乙型肝炎的效果观察

目的观察替比夫定治疗HBeAg阳性慢性乙型肝炎的效果。方法回顾性分析2010年2月～2012年2月于沈阳市第六人民医院传染科治疗的HBeAg阳性慢性乙型肝炎患者104例的临床资料。将采用替比夫定治疗的52例患者作为替比夫定组,将采用拉米夫定治疗的52例患者作为拉米夫定组,观察并比较两组治疗12、24、52周ALT复常、HBV DNA转阴、HBeAg血清学转换情况。结果治疗12周,两组ALT复常率、HBV DNA转阴率及HBeAg血清学转换率,差异均无统计学意义（P〉0.05）;治疗24周时,替比夫定组HBeAg血清学转换率（13.5%）高于拉米夫定组（5.8%）,差异有统计学意义（P〈0.05）;治疗52周时,替比夫定组ALT复常率、HBV DNA转阴率及HBeAg血清学转换率均高于拉米夫定组,差异均有统计学意义（P〈0.05）。结论采用替比夫定治疗HBeAg阳性慢性乙型肝炎的效果较好,安全性较高,值得临床推广应用。     

三种核苷类似物对慢性乙型肝炎患者肾功能影响的长期随访研究

目的：探讨替比夫定、恩替卡韦和阿德福韦酯治疗慢性乙型肝炎疗效及对肾功能的影响。方法抽取2011年1月—2014年1月分别行替比夫定（替比夫定组）、恩替卡韦（恩替卡韦组）和阿德福韦酯（阿德福韦酯组）治疗的慢性乙型肝炎患者各40例,共干预104周,比较临床疗效、不良反应及治疗前后肾功能指标。结果替比夫定组治疗104周HBV-DNA阴转率、HBeAg血清学转换率、总有效率均显著高于阿德福韦酯组（P﹤0.05）。恩替卡韦组HBV-DNA阴转率、ALT复常率及总有效率均明显高于阿德福韦酯组（P﹤0.05）。3组治疗104周替比夫定组和恩替卡韦组血肌酐水平明显低于阿德福韦酯组,且替比夫定组低于恩替卡韦组（P﹤0.05）;估计肾小球滤过率明显高于阿德福韦组,且替比夫定组高于恩替卡韦组（P﹤0.05）。3组不良反应发生率比较差异无统计学意义（P﹥0.05）。结论相比阿德福韦酯,替比夫定、恩替卡韦治疗慢性乙型肝炎整体疗效明显,且替比夫定相比恩替卡韦在保护患者肾功能上更有优势。     

Safety of long-term nucleos(t)ide treatment in chronic hepatitis B

Currently, five nucleos(t)ide analogs (NAs) are approved for the treatment of chronic hepatitis B (CHB) infection. They are lamivudine, adefovir dipivoxil, telbivudine, entecavir (ETV) and tenofovir disoproxil fumarate (TDF). Two of them, ETV and TDF, are recommended as first-line treatment options. Their main advantages include excellent tolerability, antiviral potency and a high genetic barrier to resistance within medium duration treatment periods (2 - 6 years). In most patients, NAs need to be administered on a long-term basis. Several studies suggest that NAs long-term administration have been associated with low rates of serious adverse events (AEs), including lactic acidosis, renal function impairment, osteopenia and osteoporosis. Discontinuations due to AEs tended to be low in published randomized clinical trial and in the experience in clinical practice. NAs long-term use appears to be safe and effective; and in patients with advanced liver disease, despite preliminary concerning reports, their short-term use also appears to be safe and effective. Although major AEs are infrequent, they can be initially clinically silent yet lead to serious medical problems, therefore, a proactive surveillance and their prompt management is recommended.     

4种核苷类药物治疗慢性乙型肝炎2年的成本-效果分析

目的对拉米夫定、阿德福韦酯、替比夫定和恩替卡韦4种药物治疗慢性乙型肝炎2年作成本-效果分析,找出适合临床的最佳治疗方案。方法对本科门诊诊治的200例慢性乙型肝炎患者的2年诊疗经过和疗效进行统计,包括肝功能指标ALT复常率、HBVD-NA转阴率、HBeAg转阴率及其血清学转换率和耐药率。计算药物单价、疗程费用、药物成本-效果及敏感度分析。结果这4种药物拉米夫定、阿德福韦酯、替比夫定和恩替卡韦均对治疗慢性乙型病毒性肝炎有效,疗效分别为7.8%,3.2%,35.8%和86%。成本-效果比值分别为1379.99元、4 129.12元、460.55元和308.73元。以恩替卡韦为基准,每增加一个效果单位拉米夫定、阿德福韦酯、替比夫定分别需要增加201.88元,161.08元,200.47元。结论治疗慢性乙型肝炎2年以恩替卡韦有效率最高,成本-效果值最低,效果最佳。     

Entecavir: a new nucleoside analogue for the treatment of chronic hepatitis B

Infection with hepatitis B virus (HBV) is extremely widespread - it infects two billion people out of the six billion world population. It is estimated that between 350 and 400 million people are chronically infected with HBV. Chronic HBV infection leads to development of complications, such as cirrhosis and hepatocellular carcinoma (HCC), which arise in 15-40% of patients. HBV-related liver disease and its complications result in approximately one million deaths each year. The ultimate goals of chronic hepatitis B (CHB) therapy are decreases in the incidence of cirrhosis, end-stage liver disease and HCC. The following six medications are currently approved by the U.S. Food and Drug Administration for the treatment of CHB: interferon (INF)-alpha2b, pegylated INF-alpha2a, lamivudine, adefovir dipivoxil, entecavir and, recently, telbivudine. Interferon therapy has many contraindications and commonly causes multiple intolerable adverse effects. Lamivudine therapy leads to increased development of resistant mutations with each year of use. Entecavir, a new guanosine nucleoside analogue with specific activity against HBV DNA polymerase, represents a third agent within the nucleoside/nucleotide HBV polymerase inhibitor class. It has distinct advantages over lamivudine and adefovir dipivoxil: it has a three-step mechanism of action, is the most potent inhibitor of HBV DNA polymerase, is not associated with any major adverse effects and has a limited potential for resistance. In clinical trials, entecavir was superior to lamivudine in all primary endpoints in both nucleoside-naive and lamivudine-refractory hepatitis B e antigen (HBeAg)-positive and HBeAg-negative patients. Preliminary data support entecavir efficacy in patients with cirrhosis and HIV/HBV coinfected patients. No resistance occurred after two years of entecavir therapy in nucleoside-naive patients. Up to 9% resistance developed in patients with documented prior lamivudine resistance during 96 weeks of entecavir therapy. Currently, entecavir should be considered a first- or second-line treatment option for the management of HBeAg-positive or -negative nucleoside-naive or lamivudine-refractory CHB patients.     

Therapy of chronic hepatitis B: trends and developments

There are now five nucleoside/nucleotide analogs approved for the treatment of chronic hepatitis B (CHB) including three agents approved in the United States and/or European Union in the past three years. Each of these drugs has demonstrated short-term benefits in patients including histologic improvement, HBeAg seroconversion, suppression of hepatitis B virus (HBV) DNA, and alanine aminotransferase (ALT) normalization. However, long-term therapy is required in most patients and the five approved agents differ with respect to resistance profile and ability to achieve complete antiviral suppression. Lamivudine was the first approved agent, but its use leads to frequent antiviral resistance. Adefovir dipivoxil has a superior first line resistance profile and is fully active against lamivudine-resistant HBV. Newer agents including tenofovir disoproxil fumarate, entecavir, and telbivudine offer greater potency than lamivudine and adefovir dipivoxil. However, telbivudine resistance rates are comparatively high and both telbivudine and entecavir have decreased efficacy against lamivudine-resistant HBV. Tenofovir disoproxil fumarate, the most recently approved nucleotide (2008 in the European Union, and United States), is highly potent in both treatment-na?ve and treatment-experienced patients. Overall, this class of compounds presents the opportunity to achieve complete antiviral suppression in the majority of patients, at least in the short-term. The challenge is how to best use these drugs long-term to minimize antiviral resistance and maintain maximal antiviral suppression, which is anticipated to make the greatest impact on limiting advanced complications of CHB.     

阿德福韦酯联合恩替卡韦治疗对拉米夫定耐药的慢性乙型肝炎临床疗效观察

目的比较阿德福韦酯联合拉米夫定和阿德福韦酯联合恩替卡韦对拉米夫定耐药的慢性乙型肝炎患者的疗效。方法 140例对拉米夫定耐药慢性乙型肝炎的门诊患者随机分为两组:联合用药A组和联合用药B组。A组患者服用阿德福韦酯10mg/d,加服拉米夫定100mg/d,B组在服用阿德福韦酯时,服恩替卡韦0.5mg/d,所有患者均治疗2年。治疗前、治疗0.5、1、1.5和2年分别检测HBV-DNA和ALT。结果两组患者治疗后平均ALT水平均显著降低,HBV-DNA转阴率和ALT复常率显著增加,而联合用药B组明显优于A组。结论对于拉米夫定耐药的慢性乙型肝炎患者,可优先考虑采用阿德福韦酯联合恩替卡韦进行治疗。     

拉米夫定联合阿德福韦酯治疗乙肝肝硬化的效果研究

目的研究恩替卡韦与拉米夫定联合阿德福韦酯治疗慢性乙型病毒性肝炎(乙肝)肝硬化患者的临床效果。方法 86例乙肝肝硬化患者为研究对象,随机分为观察组(42例)和对照组(44例)。两组患者均采用保肝、利尿及间断输注白蛋白等基本常规治疗,在此基础上对照组患者采用恩替卡韦治疗,观察组采用拉米夫定联合阿德福韦酯治疗。观察比较两组患者治疗前后的肝功能指标[血清白蛋白/球蛋白比值(A/G)、谷丙转氨酶(ALT)、总胆红素(TBIL)]。结果治疗前,两组患者A/G、ALT、TBIL水平比较,差异无统计学意义(P>0.05);治疗后,观察组患者A/G(1.71±0.56)高于对照组的(1.21±0.46),ALT(30.52±4.24)U/L、TBIL(90±22)μmol/L均低于对照组的(76.78±9.24)U/L、(122±28)μmol/L,差异有统计学意义(P<0.05)。结论恩替卡韦与拉米夫定联合阿德福韦酯治疗方案均可很好改善乙肝肝硬化患者的肝功能,而阿德福韦酯联合拉米夫定治疗方案改善乙肝肝硬化患者肝功能效果更好,并且联合用药较单一用药可降低耐药性,值得临床推广。     

Adefovir dipivoxil: a review of its use in chronic hepatitis B

Adefovir dipivoxil (Hepsera) is an oral prodrug of the nucleotide analogue adefovir. It is indicated for the treatment of chronic hepatitis B in adults. Adefovir dipivoxil 10 mg/day significantly improved histological, biochemical and virological outcomes in hepatitis B e antigen (HBeAg)-positive and -negative patients, and serological outcomes in HBeAg-positive patients. In two trials, the proportion of adefovir dipivoxil recipients showing histological improvement in the liver was approximately twice that for placebo recipients. In two trials in patients chronically infected with lamivudine-resistant hepatitis B virus (HBV), switching to or adding adefovir dipivoxil was significantly more effective at reducing serum HBV DNA levels than continuing lamivudine monotherapy. In treatment-naive patients, 1 year's treatment with adefovir dipivoxil plus lamivudine had similar efficacy to lamivudine plus placebo; however, lamivudine-resistant HBV emerged in significantly more patients receiving lamivudine plus placebo. Adefovir dipivoxil has also shown efficacy in noncomparative trials in patients with decompensated liver disease, patients co-infected with HIV and patients pre- or post-liver transplantation. Within 96 weeks of treatment with adefovir dipivoxil, a resistance-conferring mutation emerged in viral isolates from 1.6% of patients. In vitro, these isolates remained sensitive to lamivudine, while lamivudine-resistant HBV isolates remained sensitive to adefovir dipivoxil. Adefovir dipivoxil 10 mg/day is generally well tolerated. In a pooled analysis of 48-week data from two trials, there was no marked difference in adverse events or laboratory abnormalities between adefovir dipivoxil and placebo recipients. Within 96 weeks of treatment with adefovir dipivoxil, >1% of patients with adequate renal function developed an increase in serum creatinine levels of >/=0.5 mg/dL above baseline. Within 48 weeks of treatment, increases in serum creatinine levels of >/=0.5 mg/dL above baseline were observed in 13% of pre- and post-liver transplantation patients who generally had renal insufficiency or risk factors for renal dysfunction at baseline. Most patients continued treatment with dosage adjustments. CONCLUSION: Oral adefovir dipivoxil is effective and generally well tolerated in HBeAg-positive and -negative patients chronically infected with wild-type or lamivudine-resistant HBV. Few resistant HBV mutants have emerged to date. Data from ongoing long-term studies are awaited with interest. Existing treatment options for patients with chronic hepatitis B are limited in both number and effectiveness; the proven efficacy, good tolerability profile and apparently low potential for resistance of adefovir dipivoxil make it a promising new option in the management of this disease.     

细胞毒性药物在肝肾功能不全患者中的剂量调整

目的：探索细胞毒性药物在肝肾功能不全患者中的剂量调整。方法：以"细胞毒性药物","肝功能不全","肾功能不全"为关键词对Pubmed,EMbase,Cochrane Library,中国知网,万方,维普等数据库进行检索,以整理和归纳细胞毒性药物在肝肾功能不全患者中的剂量调整策略。结果：肝肾功能不全可影响药物的代谢动力学,进而影响药物的安全性和有效性。45种常见细胞毒性药物,当肝功能不全时,有41种药物需要进行剂量调整;当肾功能不全时,有33种药物需要进行剂量调整。结论：应重视细胞毒性药物在肝肾功能不全患者中的剂量调整,以保障患者用药的安全性和有效性。     

核苷类药物治疗慢性乙型肝炎的进展

目的:核苷类药物(nucleoside and nucleotide analogs,NAs)是临床最常用的一大类抗乙型肝炎病毒药物,笔者概述常用NAs特点及其耐药的管理、经济评估以及抗病毒治疗指征等方面的进展。方法:在Pub Med、Cochrane Central、EMbase英文数据库和CNKI、Wan Fang Data等中文数据库检索信息,搜集了慢性乙型肝类(CHB)流行病学、NAs治疗CHB的临床试验及荟萃分析、NAs耐药性、NAs治疗CHB的经济评估、CHB治疗指南(美国、欧洲、亚太及中华肝病学会)等相关文献并总结分析。结果与结论:目前恩替卡韦(ETV)和替诺福韦酯(TDF)因其强效、不易产生耐药被指南推荐为一线用药,其余NAs均被建议在无法使用ETV和TDF时使用。耐药是NAs治疗过程中必须重视的一大问题,可导致疾病进展、增加治疗的难度与成本。目前的研究揭示了相关耐药位点与产生耐药的模式,在临床具体应用中,应通过加强教育、合理选择用药、重视监测、及时补救治疗等手段减少和应对耐药。在我国CHB的长期治疗中,与TDF以外的NAs相比,ETV具有较好的成本效益。临床上需严格掌握抗病毒治疗的指征,避免不必要用药的同时,及时对符合治疗指征的患者抗病毒治疗并进行监测。     

Entecavir: a review of its use in the treatment of chronic hepatitis B in patients with decompensated liver disease

The oral deoxyguanosine nucleoside analogue entecavir (Baraclude?) has potent activity against hepatitis B virus (HBV) and a high genetic barrier to resistance. This article reviews the clinical efficacy and tolerability of entecavir in the treatment of chronic hepatitis B in patients with decompensated liver disease, as well as summarizing its pharmacological properties. Entecavir 1?mg/day was more effective than adefovir dipivoxil 10?mg/day in the treatment of patients with chronic hepatitis B and decompensated liver disease, according to the results of a randomized, open-label, multicentre trial. Patients were either nucleos(t)ide naive or lamivudine experienced. The reduction from baseline in HBV DNA levels at week 24 (primary endpoint) was significantly greater with entecavir than with adefovir dipivoxil. The proportion of patients with HBV DNA levels of <300 copies/mL was also significantly greater with entecavir than with adefovir dipivoxil at weeks 24, 48 and 96, as was the proportion of patients with ALT normalization. Entecavir 0.5 or 1?mg/day, tenofovir disoproxil fumarate 300?mg/day and a fixed-dose combination of emtricitabine/tenofovir disoproxil fumarate 200?mg/300?mg per day were effective in the treatment of chronic hepatitis B in patients with decompensated liver disease, according to the 48-week analysis of a randomized, double-blind, multicentre trial, primarily designed to examine tolerability endpoints. In this trial, over one-third of patients had received previous therapy with lamivudine for ≥6 months. The efficacy of entecavir in treatment-naive patients with HBV-related decompensated cirrhosis did not significantly differ from that seen in patients with chronic hepatitis B or compensated cirrhosis (compensated group), according to the results of a prospective, nonrandomized study. After 6 or 12 months of entecavir treatment, there were no significant differences between the decompensated and compensated groups in virological, biochemical or serological endpoints. In patients with decompensated cirrhosis, significant improvements from baseline in liver function were seen after 12 months of entecavir therapy. Oral entecavir was generally well tolerated in patients with chronic hepatitis B and decompensated liver disease, with most of the reported treatment-emergent adverse events consistent with decompensated liver disease. In the trial primarily designed to examine tolerability endpoints, there was no significant difference between patients receiving entecavir and those receiving tenofovir disoproxil fumarate with or without emtricitabine in terms of the proportion of patients experiencing tolerability failure or the proportion of patients with confirmed increases in serum creatinine levels of ≥0.5?mg/dL above baseline or confirmed serum phosphorus levels of <2.0?mg/dL at week 48 (co-primary endpoints). It has been suggested that the risk of lactic acidosis associated with oral nucleos(t)ide analogue therapy is increased in patients with highly impaired liver function. However, only one case of lactic acidosis was reported among entecavir recipients across two clinical trials in patients with chronic hepatitis B and decompensated liver disease. Moreover, small studies found that the risk of lactic acidosis was not increased in patients with chronic hepatitis B and decompensated liver disease who received entecavir, compared with patients with non-HBV decompensated liver disease. In conclusion, entecavir is a valuable agent for the first-line treatment of chronic hepatitis B in patients with decompensated liver disease.