BackgroundSerum hepatitis B surface antigen (HBsAg) < 100 IU/mL has been recently proposed as one of the key criteria of ‘partial cure’ in patients with chronic hepatitis B virus (HBV) infection. We analysed the clinical prognosis of hepatitis B e antigen (HBeAg)‐negative untreated patients with HBsAg < 100 IU/mL and normal alanine aminotransferase (ALT) levels.MethodsFive hundred and twenty‐one untreated patients with HBeAg negativity, HBsAg < 100 IU/mL and normal ALT levels were included from three hospitals. Spontaneous HBsAg seroclearance, phase transition, liver fibrosis progression and hepatocellular carcinoma (HCC) development were analysed.ResultsThe median age was 43.0 years, and 62.2% of the patients were male. After a median follow‐up of 25.0 months, 52 (10.0%) patients achieved spontaneous HBsAg seroclearance. The annual HBsAg seroclearance rate is 4.2%. Patients with baseline HBsAg ≤ 10 IU/mL (adjusted hazard ratio [aHR] = 3.490, p < 0.001) and male sex (aHR = 1.980, p = 0.041) were more likely to achieve HBsAg seroclearance. Only 4 (0.8%) and 23 (4.8%) patients transitioned to the immune escape phase and HBeAg‐negative indeterminate phase, respectively. Baseline serum HBsAg > 10 IU/mL (aHR = 3.846, p = 0.034) and detectable HBV DNA (aHR = 2.672, p = 0.023) were associated with transition to the HBeAg‐negative indeterminate phase. No patient developed HCC or had fatal outcomes.ConclusionsHBeAg‐negative patients with serum HBsAg < 100 IU/mL and normal ALT levels had a favourable prognosis. HBsAg ≤ 10 IU/mL and male sex were associated with a higher rate of HBsAg seroclearance, while HBsAg > 10 IU/mL and detectable HBV DNA were associated with a higher risk of transition to the indeterminate phase.

中文翻译：

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未经治疗的 HBeAg 阴性慢性乙型肝炎病毒感染 HBsAg < 100 IU/mL 患者预后良好


背景血清乙型肝炎表面抗原 （HBsAg） < 100 IU/mL 最近被提议作为慢性乙型肝炎病毒 （HBV） 感染患者“部分治愈”的关键标准之一。我们分析了乙型肝炎 e 抗原 （HBeAg） 阴性、未经治疗的 HBsAg < 100 IU/mL 和丙氨酸氨基转移酶 （ALT） 水平正常的患者的临床预后。方法纳入来自 3 家医院的 521 例未经治疗的 HBeAg 阴性、HBsAg < 100 IU/mL 和 ALT 水平正常患者。分析自发性 HBsAg 血清清除率、相变、肝纤维化进展和肝细胞癌 （HCC） 发展。结果中位年龄 43.0 岁，62.2% 的患者为男性。中位随访 25.0 个月后，52 例 （10.0%） 患者实现了自发性 HBsAg 血清清除。HBsAg 年血清清除率为 4.2%。基线 HBsAg ≤ 10 IU/mL （调整后风险比 [aHR] = 3.490，p < 0.001） 和男性 （aHR = 1.980，p = 0.041） 的患者更有可能实现 HBsAg 血清清除。只有 4 例 （0.8%） 和 23 例 （4.8%） 患者分别过渡到免疫逃逸期和 HBeAg 阴性不确定期。基线血清 HBsAg > 10 IU/mL （aHR = 3.846，p = 0.034） 和可检测到的 HBV DNA （aHR = 2.672，p = 0.023） 与向 HBeAg 阴性不确定期的转变相关。没有患者发生 HCC 或有致命的结局。结论血清 HBsAg < 100 IU/mL 且 ALT 水平正常的 HBeAg 阴性患者预后良好。HBsAg ≤ 10 IU/mL 和男性与 HBsAg 血清清除率较高相关，而 HBsAg > 10 IU/mL 和可检测到的 HBV DNA 与转变为不确定期的风险较高相关。