血清乙型肝炎病毒前S1抗原对判定HBV DNA复制的临床价值

目的通过分析HBV Pre-S1抗原与HBeAg和HBV DNA的相关性,以探讨其在诊断HBV复制的临床价值。方法采用ELISA法、荧光定量PCR法检测450例HBsAg阳性及50例健康对照血清标本的HBV Pre-S1抗原、血清HBV标志物、HBV DNA及肝功能。结果在450例HBsAg阳性血清中,HBeAg、Pre-S1抗原和HBV DNA阳性率分别为40.0%、57.3%和61.6%;Pre-S1抗原、HBV DNA阳性率在HBeAg阴性与阳性组间差异有统计学意义（x2=84.2,x2=110.7,P〈0.01）;PreS1抗原与HBeAg和HBV DNA均存在相关性（x2=86.5x,2=272.1,P〈0.01）;Pre-S1抗原阳性组AST、ALT、TBl、γ-GT均高于阴性组（P〈0.01）;当HBV DNA拷贝数的对数值〉2.7lgcopies/ml时,Pre-S1抗原诊断HBV复制的敏感度为87.7%,特异度为91.3%,准确性为89.1%,阳性预测值为94.2%,阳性似然比为10.1,优势比为75.3,而HbeAg则分别为59.2%、90.8%、71.3%、91.1%、6.43和14.2。结论 HBV Pre-S1抗原与HBeAg和HBV DNA均有较好的相关性,可作为一项新的病毒复制的指标。     

乙型肝炎患者前S_1抗原与病毒血清学标志物及HBVDNA含量的相关性分析

目的：探讨乙型肝炎患者前S1（Pre-S1）抗原与病毒血清学标志物（HBV-M）、HBV DNA含量的相关性,以评价Pre-S1抗原检测的临床应用价值。方法：检测316例乙型肝炎患者病毒Pre-S1与HBV-M及HBV DNA含量,并进行相关性分析。结果：Pre-S1在HBeAg阳性患者中阳性率为95.7%,与HBeAg及HBV DNA具有相关性（P〈0.01）。结论：Pre-S1与HBV DNA具有相关性,且较HBeAg更敏感,可以作为评价HBV复制的重要指标。     

前S1抗原在乙肝病毒感染与复制中的作用

目的 传统乙肝血清标志物是目前我国用于乙肝检测与筛查较普及的指标,但传统乙肝HBV-M检测在病毒复制等一些方面尚有不足.本研究分析前S1（Pre-S1）抗原在判断乙肝病毒的感染与复制中的作用.方法 HBV-M和Pre-S1抗原检测采用ELISA法;HBV DNA检测采用实时荧光定量PCR技术.结果 （1）Pre-S1抗原在乙肝病毒早期感染中的作用：787例ALT正常血清中,Pre-S1抗原阳性34例,HBV-M检测HBsAg（＋）2例,HBsAg（＋）、HBeAg（＋）1例,HBsAg（＋）、HBeAg（＋）、HBcAb（＋）7例,HBsAg（＋）、HBeAb（＋）、HBcAb（＋）18例,HBsAg（＋）、HBcAb（＋）4例,HBV DNA阳性35例,三者检出结果高度符合,无显著差异（P＞0.05）.（2）Pre-S1抗原在乙肝病毒复制中的作用：816例慢性乙肝患者中,HBeAg（＋）/HBeAb（-）396例,Pre-S1抗原阳性357例,HBV DNA阳性371例,阳性检出率分别为90.1%和93.6%.HBeAg（-）/HBeAb（＋）285例,Pre-S1抗原阳性223例,HBV DNA阳性247例,阳性检出率分别为78.2%和86.7%.HBeAg（-）/HBeAb（-）135例,Pre-S1抗原阳性85例,HBV DNA阳性105例,阳性检出率分别为62.9%和77.7%,若以HBV DNA≥103copy/ml为判断乙肝病毒存在复制的标准,则Pre-S1抗原的检出率为79%（414/525）,HBeAg（＋）的检出率为32.7%（172/525）;Pre-S1抗原、HBeAg（＋）与HBV DNA的总符合率分别为78.8%（615/723）、45.5%（327/723）,HBV DNA与Pre-S1抗原检出率差异无显著性（P＞0.05）,HBeAg（＋）与HBV DNA检出率差异有显著性（P＜0.05）.结论 Pre-S1抗原是乙肝病毒早期诊断与病毒复制的重要标志.     

e抗原阴性患者抗病毒治疗中乙型肝炎前S1抗原的变化

目的 通过对乙型肝炎患者前S1抗原(Pre-S1抗原)检测,了解乙肝病毒(HBV)的复制情况,并用于指导e抗原(HBeAg)阴性的患者进行抗病毒治疗.方法 在我院2004年4月～2006年5月门诊及住院慢性乙肝患者中,采用外周血进行肝功能、Pre-S1抗原、乙肝五项等检查,其Pre-S1抗原阳性、HBeAg阴性的29例患者,采用α-干扰素抗病毒治疗6月,分析Pre-S1抗原在抗病毒治疗前的血清学变化.结果 经α-干扰素抗病毒治疗6月后,患者临床症状基本消失,Pre-S1抗原阴转26例,肝功能基本恢复正常,ALT 52±17 U/L.结论 HBeAg阴性而Pre-S1抗原阳性的患者,在体内存在病毒复制,同时存在肝功能的损害,仍需要抗病毒治疗.     

血清乙型肝炎病毒前S1及前S2抗原与HBV-DNA的相关性研究

目的:了解血清乙型肝炎病毒(HBV)前S1(Pre-S1)抗原与前S2(Pre-S2)抗原与HBV-DNA的相关性。方法:采用酶联免疫吸附法(ELISA)检测320例乙肝患者血清Pre-S1抗原与Pre-S2抗原,同时采用荧光定量PCR方法检测血清HBV-DNA水平。结果:199例HBV-DNA阳性的乙肝患者Pre-S1抗原和Pre-S2抗原的阳性率分别为82.9%和75.9%;121例HBV-DNA阴性的乙肝患者Pre-S1抗原和Pre-S2抗原的阳性率分别为35.5%和26.4%。HBV-DNA阴性组和HBV-DNA阳性组患者的Pre-S1抗原及Pre-S2抗原阳性率均差异有统计学意义(均P0.01),且Pre-S1、Pre-S2抗原阳性率与HBV-DNA载量呈高度相关性。结论:Pre-S1与Pre-S2抗原是病毒感染和复制的指标,与HBV-DNA具有高度相关性,对临床标本进行HBV-DNA与Pre-S1、Pre-S2抗原联合检测,可弥补HBV-DNA检测的不足,对预防HBV复制和传播有重要价值。     

Pre-S1Ag与e抗原定量、HBV-DNA的相关性

目的探讨乙肝病毒前S1抗原(Pre-S1Ag)与e抗原(HBeAg)定量检测及乙肝病毒定量(HBV-DNA)检测的相关性,评价Pre-SlAg的临床检测意义。方法选择2009年4月至2013年10月在吉林大学第一医院二部就诊的220例未应用任何抗HBV药物治疗的慢性乙肝患者,其血清进行酶联免疫吸附试验(ELISA)检测Pre-S1Ag、酶联免疫法检测HBeAg、PCR-荧光探针法检测HBV-DNA,对照三者的相关联系及意义。结果 (1)220例乙肝病毒感染者中,PreS1阳性184例,阴性36例;PreS1、HBV-DNA均阳性133例,均阴性30例,PreS1阳性、HBV-DNA阴性35例,PreS1阴性、HBV-DNA阳性22例。(2)Pre-S1A阳性率与HBV-DNA检测有统计学差异(P<0.000 1),HBeAg检测与HBV-DNA检测有统计学差异(P<0.000 1),但Pre-S1A阳性率与HBeAg检测无统计学差异(P=0.508 1)。PreS1阳性率在HBV-DNA阳性、HBeAg阳性组与HBV-DNA阴性、HBeAg阳性组有统计学差异(P<0.000 1);在HBV-DNA阳性、HBeAg阳性组与HBV-DNA阴性、HBeAg阴性组有统计学差异(P=0.000 5);在HBV-DNA阴性、HBeAg阳性组与HBV-DNA阳性、HBeAg阴性组有统计学差异(P=0.000 5);在HBV-DNA阳性、HBeAg阴性组与HBV-DNA阴性、HBeAg阴性组无统计学差异(P=0.108 2)。结论 PreS1与HBV-DNA符合率较高,比HBeAg更能反映病毒复制情况,可作为一项监测HBV复制的一项新的指标。     

前S2抗原与HBVDNA及HBV血清标志物的关系分析

目的探讨乙型肝炎病毒前S2（Pre-S2）抗原与乙肝病毒血清标志物五项、乙肝病毒DNA之间的相关性及临床意义。方法用酶联免疫吸附试验对982例乙肝患者血清标志物和乙肝病毒Pre-S2抗原进行检测;并用荧光定量PCR法对其进行HBVDNA检测。对HBV血清标志物不同阳性血清学模式进行分组分析。结果在HBeAg阳性模式组中,乙肝病毒Pre-S2和HBVDNA的检出率高,平均为95.34%和97.8%。在HBeAg阴性模式组中,乙肝病毒Pre-S2和HBVDNA的检出率低,平均为39.7%和32.3%。在HBsAg、HBeAg均为阴性的模式中Pre-S2抗原为1.45%。结论 Pre-S2抗原与HBeAg和HBVDNA密切相关;Pre-S2抗原检测完善和补充了乙肝病毒血清标志物检测的不足。     

乙型肝炎患者血清前S1抗原检测的意义

目的 探讨对乙型肝炎(乙肝)患者检测血清前S1抗原(Pre-S1Ag)的临床价值.方法 对550例乙肝患者检测血清Pre-S1Ag及HBV-DNA、HBeAg、ALT、AST、γ-GT.结果 HBV-DNA阳性者HBeAg、Pre-S1Ag的检出率分别为31.5%和81.1%;与HBV-DNA检出符合率比较,P分别＜0.01和＜0.05.Pre-S1Ag阳性与阴性患者的ALT、AST及γ-GT水平比较,P分别＜0.01和＜0.05.结论 Pre-S1Ag与HBV-DNA检出率相近,可作为HBV存在的指标,Pre-S1Ag的存在与肝功能的损害关系密切.     

慢性乙型肝炎患者血清前S1抗原与血清HBV DNA和HBeAg 的关系探讨

目的：探讨 HBV 前 S1抗原与血清 HBV DNA 和 HBeAg 的关系。方法选择我院收治的100例慢性乙型肝炎患者,采用双抗体夹心 ELISA 法检测 HBV 前 S1抗原,常规检测 HBV DNA 和 HBeAg。结果在100例 CHB 患者中,血清前 S1抗原阳性88例（88.0%）,血清 HBV DNA 阳性71例（71.0%）,前 S1抗原阳性率显著高于 HBV DNA （x2=5.358,P＜0.05）;100例患者HBV DNA 和前 S1抗原两者均阳性或均阴性者共69例（69.0%）,而在血清 HBV DNA 阳性者中血清前 S1抗原阴性率为9.9%（7/71）,在血清前S1抗原阳性者中,血清 HBV DNA 阴性率为27.3%（24/88）;血清前 S1抗原与 HBeAg 同时阳性或阴性者共33例（33.0%）,而在血清 HBeAg 阳性者中,前 S1抗原阴性率为21.6%（8/37）,在前 S1抗原阳性者中,HBeAg 阴性率为67.0%（59/88）。结论在慢性乙型肝炎患者,前 S1抗原可能比血清 HBV DNA 和 HBeAg 有更高的阳性率。     

慢性HBV感染者血清HBeAg、HBV DNA载量与肝组织病理损伤的关系

目的对比不同年龄阶段乙型肝炎e抗原（HBeAg）阳性及HBeAg阴性慢性乙型肝炎病毒（HBV）感染者的肝脏病理特点。方法 323例慢性HBV感染者分为HBeAg阳性组与HBeAg阴性组,每组以40岁为界分为高龄组与低龄组,均经肝穿刺活组织检查,同时检测血清丙氨酸氨基转移酶（ALT）、HBV DNA,分析HBeAg阳性与HBeAg阴性患者高龄组与低龄组的肝脏病理损伤与血清ALT及HBV DNA水平的关系。结果 HBeAg阳性高龄组与HBeAg阴性高龄组比较具有更明显的炎症程度（P〈0.05）及更高的HBV DNA载量（P〈0.01）,HBeAg阳性低龄组与HBeAg阴性低龄组比较HBV DNA载量较高（P〈0.01）,但炎症程度无明显差异（P〉0.05）。HBeAg阴性非活动性HBV携带者与HBeAg阴性慢性乙型肝炎患者肝脏病理炎症、纤维化程度及血清HBV DNA水平在高龄组差异有统计学意义（P〈0.01）,而在低龄组差异无统计学意义。结论慢性HBV感染者血清HBeAg表达和HBV DNA水平与肝组织病理炎症分级的关系在不同年龄阶段表现不同,血清HBeAg表达与否和HBV DNA水平高低不能单独作为判断肝组织病理变化程度的指标。     

Expression of pre-S gene-encoded proteins in liver and serum during chronic hepatitis B virus infection in comparison to other markers of active virus replication

Pre-S gene-encoded proteins of the hepatitis B virus (HBV) were studied in the liver by immunofluorescence and in serum by radioimmunoassay in 30 patients with chronic HBV infection. The results were compared with molecular hybridization analysis of HBV-DNA in liver and serum, with serum hepatitis B e antigen/antibody (HBeAg/anti-HBe) status and with underlying liver histology. Pre-S peptides were detected in the serum of 11 patients, 10 of whom were positive for serum HBV-DNA and/or liver hepatitis B core antigen. Only 4 of these patients were HBeAg positive. The prevalence of serum pre-S among HBV replicating carriers was 59% (10/17) compared to only 8% (1/13) among those with non-replicating virus (P less than 0.01). All patients with circulating pre-S peptides had active liver disease. Anti-pre-S was detected in the serum of only 4 patients, 3 with integrated HBV-DNA. In contrast to serum findings, pre-S peptides were detected in the liver of all patients with histochemically demonstrable hepatitis B surface antigen (HBsAg), regardless of HBV replicative status. HBsAg carriers with integrated HBV-DNA had abundant cytoplasmic pre-S1 and pre-S2 localized in numerous ground-glass hepatocytes. It is concluded that pre-S peptides are usually displayed in the liver simultaneously with histochemically detectable HBsAg; they are secreted in the serum in association with high HBV replication and release of HBV particles, but in the absence of episomal HBV replication, pre-S peptides seem to be largely retained within hepatocytic membranes.     

Precore and core promoter mutations of hepatitis B virus and hepatitis B e antigen-negative chronic hepatitis B in Korea

BACKGROUND/AIMS: The aims of this study were to determine the frequency of precore/core promoter mutations and hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (e-CHB) in Korea. METHODS: Patients with chronic hepatitis B virus (HBV) infection were tested for HBeAg, anti-HBe, liver profile and HBV-DNA by a branched DNA (bDNA) assay. Serum HBV-DNA was amplified by a polymerase chain reaction and the precore/core promoter sequence was determined. RESULTS: Among the 413 consecutive HBeAg-negative patients, 19.6% were bDNA-positive. Evidence of liver disease was found in 90.1% of bDNA-positive and 41.7% of bDNA-negative patients. Overall, 17.7% of HBeAg-negative patients had e-CHB. Precore mutation (A1896) was detected in 93.7% of HBeAg-negative bDNA-positive and 93.9% of HBeAg-negative bDNA-negative patients. In 59 HBeAg-positive patients, 78% had wild-type and 22% had a mixture of wild-type and A1896 mutant. Core promoter TA mutation was detected in 89.9% of HBeAg-negative bDNA-positive patients, 89.8% of HBeAg-negative bDNA-negative patients, and 74.6% of HBeAg-positive patients. No correlation was found between the presence of precore/core promoter mutations and HBV-DNA levels or disease severity. CONCLUSIONS: In Korean patients infected with HBV genotype C, precore mutation occurred almost invariably along with HBeAg seroconversion and core promoter TA mutation was frequent irrespective of viral replication levels or disease severity.     

Serum hepatitis B virus DNA levels differentiating inactive carriers from patients with chronic hepatitis B

OBJECTIVE: We compared serum hepatitis B virus (HBV)-DNA levels in different states of hepatitis B infection, and investigated whether there is an HBV-DNA value that can be used for differentiating inactive carriers from patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis. METHODS: A retrospective study using sera at a followed endpoint from 64 Japanese patients with chronic HBV infection seen in Kobe University Hospital between 1989 and 2002. Sera of patients were assayed using a polymerase chain reaction-based assay. RESULTS: Genotype C was dominant (95.4%). Patients with chronic hepatitis with an elevation of the serum alanine aminotransferase (ALT) level had significantly higher HBV-DNA levels than patients with persistently normal ALT. For one time observation at a followed endpoint, the mean HBV-DNA level of HBeAg-negative inactive carriers was significantly lower than that of HBeAg-negative chronic hepatitis patients (3.6+/-1.0 versus 4.8+/-1.5 log copies/ml, P<0.005). The use of a cutoff value of 4.5 or 5.0 log copies/ml misclassified 23 and 18% of HBeAg-negative inactive carriers and 50 and 55% of patients with HBeAg-negative chronic hepatitis. If testing were performed on two occasions with approximately a 4-month interval, the cutoff values of 4.5 and 5.0 log copies/ml would misclassify 20 and 10% of HBeAg-negative inactive carriers and 28.6 and 28.6% of patients with HBeAg-negative chronic hepatitis. CONCLUSIONS: The measurement of serum HBV DNA more than twice is useful for assessing chronic hepatitis B surface antigen carriers and confirms that 10 copies/ml may be an appropriate level of HBV for characterizing the inactive carrier state.     

乙型肝炎患者HBV—DNA载量与肝功能以及乙型肝炎病毒表面抗原定量的关系

目的研究外周血中HBV—DNA载量与反映肝脏损伤的相关肝功能指标以及乙型肝炎病毒表面抗原（HBsAg）定量的关系。方法采用荧光定量PCR（FQ—PCR）检测HBV—DNA载量，用全自动生化仪检测肝功能，时间分辨法（TRFIA）测表面抗原，然后做统计分析。结果丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）水平与HBV—DNA含量以及表面抗原经相关分析无统计学意义，肝细胞损伤程度与HBV—DNA复制水平以及血清感染标志物HBsAg水平并无明显的关系。结论乙肝患者血清中HBV—DNA水平是评定HBV复制状态的一个重要指标，乙型肝炎患者HBV—DNA载量与肝功能以及表面抗原定量无关。     

Chronic carriers of hepatitis B virus in Bangladesh: a comparative analysis of HBV-DNA,HBeAg/anti-HBe,and liver function tests

Serological markers of hepatitis B virus (HBV), liver function tests and quantitative estimation of HBV-DNA are important in the assessment of the state of infection and prognosis following treatment for hepatitis B. This study aimed to determine whether low-cost assays, eg hepatitis B e antigen (HBeAg) and liver function tests, could be used for the assessment of infectivity as an alternative to HBV-DNA estimation. We tested 125 hepatitis B carriers for HBeAg, antibody to HBeAg (anti-HBe), and serum HBV-DNA; we also carried out a range of standard liver function tests. Seventy-three subjects were positive and 52 were negative for HBeAg. Of the HBeAg positive cases, 3 were also positive for anti-HBe; of the HBeAg negative cases, 5 were also negative for anti-HBe. Of these 8 cases, 7 had no detectable HBV-DNA. Most of the HBeAg positive but anti-HBe negative subjects were positive for HBV-DNA (74.3%; 52/ 70) whereas most of the HBeAg negative and anti-HBe positive subjects (93.6%; 44/47) were also negative for HBV-DNA. Of 56 HBV-DNA positive individuals, alanine transaminase (ALT) was found to be raised in 69.6% (p=0.066) and aspartate transaminase (AST) was raised in 66.1% (p=0.011), while 67.9% had normal alkaline phosphatase (ALP) (p=0.054). HBeAg (p=0.018) and raised ALT (p=0.008) were found to be independent predictors for HBV-DNA positivity among HBV carriers. This study suggests that HBeAg positive and anti-HBe negative hepatitis B carriers with raised ALT and AST are likely to be positive for HBV-DNA; the combination of routine serology and biochemical tests may be considered as an alternative to HBV-DNA in evaluating the state of chronic HBV infection. However, HBV-DNA should be specifically assessed if discordance is observed between seromarkers and transaminases.     

前S1、S2抗原在诊断乙肝病毒复制时的临床意义

目的：探讨乙型肝炎病毒Pre-S1Ag、Pre-S2Ag在诊断乙肝病毒感染复制中的临床价值。方法：对210例不同HBV血清标志物模式的标本同时进行乙肝病毒Pre-S1Ag、Pre-S2Ag和HBV-DNA检测，并将结果进行比较和分析。结果：Pre-S1Ag、Pre-S2Ag与HBV-DNA均呈正相关（r=0．9522，P〈0．05；r=0．9755，P〈0．05）。HBeAg、Pre-s1Ag、Pre-S2Ag与HBVDNA的一致率分别为55．7％、78．6％、75．7％，且HBeAg、Pre-s1Ag、Pre-S2Ag与HBVDNA的Kappa值分别为0．24、0．51、0．43，证实了Pre-s1Ag、Pre-S2Ag与HBV-DNA检测的结果有中、高度一致性。结论：血清Pre-S1Ag、Pre-S2Ag是反映乙肝病毒复制的良好指标，且其检测不需特殊仪器设备，操作简单，是传统乙肝血清标志物有益的必要补充。Pre-S1Ag、Pre-S2Ag联合乙肝血清标志物检测对乙型肝炎的诊断、疗效评价具有非常重要的临床意义。     

Expression of pre-S1 antigen and pre-S1 antibody in sera obtained from HBV infected patients

We investigated the expression of Pre-S1 antigen and Pre-S1 antibody using a synthetic peptide and the monoclonal antibody against it. Four patients with acute hepatitis B and 87 chronic HBsAg carriers were included in this study. There was a significant correlation between Pre-S1 antigen titers and HBsAg titers. Pre-S1 antigen showed higher titers in patients with active viral replication, positive for HBeAg, HBV-DNA or HBV-related DNA polymerase. The ratio of Pre-S1 antigen titers to HBsAg titers, however, had no significant relationship with those replicative markers. It was suggested that Pre-S1 antigen was expressed with an intimate relation to the expression of HBsAg and was not so useful as a new replicative marker. Pre-S1Ag titers/HBsAg titers tended to be high in patients with chronic active hepatitis and high serum GPT levels. This may be due to the release of overproduced intracellular Pre-S1 antigen. Pre-S1 antibody was detected only in few cases of chronic HBsAg carriers. This result shows that the immune tolerance to Pre-S1 region may play a role in the persistence of HBV infection.     

Cryptogenic chronic liver disease and serum or liver hepatitis B virus markers. Their possible correlations and etiologic significance

In an attempt to evaluate a possible correlation between cryptogenic chronic liver disease and a present or past hepatitis B virus (HBV) infection, we studied 17 patients with hepatitis B surface antigen (HBsAg)-negative, nonalcoholic chronic liver disease; 9 of them were positive for serum HBsAg detected by a solid-phase enzyme immunoassay with monoclonal antibody (M-EIA) and 8 were negative for the same marker. Liver hepatitis B core antigen (HBcAg), studied by an indirect immunofluorescence technique, was present in 55.5% of the patients positive for serum HBsAg by M-EIA. In the same group of patients, liver HBV-DNA was found in 66.6% of the patients. On the other hand, only 1 patient without serum positivity for HBsAg by M-EIA was positive for liver HBcAg and HBV-DNA. None of our patients showed serum positivity for HBV-DNA sequences. We conclude that HBV infection may be a possible cause of cryptogenic chronic liver disease; this HBV-related, HBsAg-negative chronic liver disease seems to have no viral replication or undetectable levels of HBV-DNA in serum. HBsAg, detected by a monoclonal assay, seems to be a suitable marker to identify this subgroup of patients with HBsAg-negative chronic liver disease.     

Profile of hepatitis B e antigen-negative chronic hepatitis B.

BACKGROUND: Although chronic hepatitis B occurs in hepatitis B e antigen (HBeAg)-negative patients, its prevalence and clinical significance are not known. AIM: To determine the prevalence and profile of HBeAg-negative chronic hepatitis B virus (HBV) infection. METHODS: A retrospective analysis of 363 consecutive patients (mean age 36 y; 288 men) with chronic HBV infection was performed. All patients were HBsAg-positive. Tests for liver profile, HBeAg and anti-HBe antibody were performed in all patients. Serum HBV DNA was tested using branched DNA assay in 245 patients. The patients were classified into three groups: no cirrhosis with normal ALT levels, no cirrhosis with elevated ALT levels, and clinical or histological evidence of cirrhosis. RESULTS: Of 363 patients, 141 (39%) were HBeAg-positive and 222 (61%) HBeAg-negative. Of HBeAg-negative patients, 120 (54%) had normal ALT, 45 (20%) had elevated ALT and 57 (26%) had evidence of cirrhosis; corresponding figures in the HBeAg-positive patients were 40 (28%), 66 (47%) and 35 (25%). HBV DNA was positive in 53 of 131 (40%) HBeAg-negative patients tested; of these 53 patients, 9 (17%) had normal ALT, 20 (38%) had elevated ALT and 24 (45%) had cirrhosis. Thus, 72% of HBeAg-positive and 46% of HBeAg-negative patients had elevated ALT and/or cirrhosis. Among the latter group, 83% of HBV DNA-positive patients had elevated ALT and/or cirrhosis. Overall, 18% of HBsAg-positive patients had HBeAg-negative, HBV DNA-positive liver disease. CONCLUSION: HBeAg-negative chronic hepatitis B is not an uncommon and benign entity and chronic liver disease develops in a significant proportion of such patients.