Department of Infectious Diseases, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, People's Republic of China.
Institute of Viruses and Infectious Diseases, Nanjing University, Nanjing, People's Republic of China.
Emerg Microbes Infect. 2024 Dec;13(1):2339944. doi: 10.1080/22221751.2024.2339944. Epub 2024 Apr 16.
Serum hepatitis B surface antigen (HBsAg) level < 100 IU/ml and undetectable hepatitis B virus (HBV) DNA have been recently proposed as an alternate endpoint of "partial cure" in chronic hepatitis B (CHB). We investigated clinical outcomes of hepatitis B e antigen (HBeAg)-negative CHB patients with HBsAg <100 IU/ml and undetectable HBV DNA. Treatment-naïve HBeAg-negative CHB patients with undetectable HBV DNA and normal alanine aminotransferase were retrospectively included from three institutions. Patients were classified into the low HBsAg group (<100 IU/ml) and the high HBsAg group (≥100 IU/ml). Liver fibrosis was evaluated by noninvasive tests (NITs). A total of 1218 patients were included and the median age was 41.5 years. Patients with low HBsAg were older (45.0 vs. 40.0 years, < 0.001) than those in the high HBsAg group, while the NIT parameters were comparable between groups. During a median follow-up of 25.7 months, patients with low HBsAg achieved a higher HBsAg clearance rate (13.0% vs. 0%, < 0.001) and a lower rate of significant fibrosis development (2.2% vs. 7.0%, = 0.049) compared to patients with high HBsAg. No patient developed HCC in either group. HBsAg level was negatively associated with HBsAg clearance (HR 0.213, < 0.001) and patients with HBsAg < 100 IU/ml had a low risk of significant fibrosis development (HR 0.010, = 0.002). The optimal cutoff value of HBsAg for predicting HBsAg clearance was 1.1 Log IU/ml. Treatment-naïve HBeAg-negative CHB patients with HBsAg <100 IU/ml and undetectable HBV DNA had favourable outcomes with a high rate of HBsAg clearance and a low risk of fibrosis progression.
血清乙型肝炎表面抗原（HBsAg）水平<100IU/ml 且乙型肝炎病毒（HBV）DNA 不可检测已被最近提出作为慢性乙型肝炎（CHB）“部分治愈”的替代终点。我们研究了 HBsAg<100IU/ml 和 HBV DNA 不可检测的 HBeAg 阴性 CHB 患者的临床结局。从三个机构回顾性纳入 HBV DNA 不可检测且丙氨酸氨基转移酶正常的治疗初治 HBeAg 阴性 CHB 患者。患者分为低 HBsAg 组（<100IU/ml）和高 HBsAg 组（≥100IU/ml）。通过非侵入性试验（NITs）评估肝纤维化。共纳入 1218 例患者，中位年龄为 41.5 岁。低 HBsAg 组患者年龄较大（45.0 岁比 40.0 岁，<0.001），而两组 NIT 参数无差异。中位随访 25.7 个月期间，低 HBsAg 组患者 HBsAg 清除率更高（13.0%比 0%，<0.001），显著纤维化进展发生率更低（2.2%比 7.0%，=0.049）。两组均无患者发生 HCC。HBsAg 水平与 HBsAg 清除呈负相关（HR 0.213，<0.001），HBsAg<100IU/ml 患者显著纤维化进展风险低（HR 0.010，=0.002）。预测 HBsAg 清除的 HBsAg 最佳截断值为 1.1 Log IU/ml。HBsAg<100IU/ml 且 HBV DNA 不可检测的治疗初治 HBeAg 阴性 CHB 患者具有良好的结局，HBsAg 清除率高，纤维化进展风险低。
