Department of Hepatology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470, Japan.
Okinaka Memorial Institute for Medical Research, Tokyo, Japan.
J Gastroenterol. 2024 Jan;59(1):34-44. doi: 10.1007/s00535-023-02046-y. Epub 2023 Oct 14.
We determined the long-term clinical outcome and the durability of treatment cessation after HBsAg seroclearance following nucleos(t)ide analog (NA) therapy in patients with chronic hepatitis B (CHB).
We analyzed virological relapse (VR), HBsAg reversion, clinical relapse, and changes in HBsAg and HBcrAg levels by iTACT assay after treatment cessation of 90 CHB patients who achieved HBsAg seroclearance by NA treatment.
Median age of patients at treatment cessation was 57 years. Median duration of NA treatment and follow-up from cessation of NA were 9.25 and 5.2 years, respectively. Although VR occurred in 19 of 90 (21.1%) patients, HBV DNA levels of 18 patients had temporal elevations and sustained levels under the detection level thereafter. HBsAg reversion using Architect HBsAg QT assay occurred in six patients (6.7%) after cessation of NA. Five patients had temporal HBsAg level elevations and sustained levels under the detection level thereafter. One patient had virological and clinical relapse at 6 months after cessation of NA, and received NA re-treatment. HBsAg levels by iTACT assay from end of treatment (EOT) gradually decreased and in 18 of 28 (64%) patients reached an undetectable level at 5 years after EOT. In contrast, HBcrAg levels by iTACT assay slowly decreased, and in 8 of 29 patients (28%) reached an undetectable level at 5 years after EOT.
Patients receiving NA treatment who achieved HBsAg seroclearance as determined by HBsAg QT assay rarely experienced virological or clinical relapse after the cessation of treatment.
我们确定了核苷（酸）类似物（NA）治疗后乙型肝炎表面抗原（HBsAg）血清学清除的慢性乙型肝炎（CHB）患者停止治疗后的长期临床结局和治疗停止的持久性。
我们通过 iTACT 检测分析了 90 例接受 NA 治疗后达到 HBsAg 血清学清除的 CHB 患者停止治疗后病毒学复发（VR）、HBsAg 逆转、临床复发以及 HBsAg 和 HBcrAg 水平的变化。
停止治疗时患者的中位年龄为 57 岁。NA 治疗和停止 NA 后随访的中位时间分别为 9.25 年和 5.2 年。尽管 19 例（21.1%）患者发生 VR，但 18 例患者的 HBV DNA 水平暂时升高，此后持续在检测水平以下。停止 NA 后，6 例（6.7%）患者使用 Architect HBsAg QT 检测发生 HBsAg 逆转。5 例患者此后 HBsAg 水平暂时升高，持续在检测水平以下。1 例患者在停止 NA 后 6 个月发生病毒学和临床复发，接受 NA 再治疗。iTACT 检测的 HBsAg 水平从治疗结束（EOT）逐渐下降，28 例（64%）患者在 EOT 后 5 年达到不可检测水平。相比之下，iTACT 检测的 HBcrAg 水平缓慢下降，29 例患者中有 8 例（28%）在 EOT 后 5 年达到不可检测水平。
通过 HBsAg QT 检测确定达到 HBsAg 血清学清除的接受 NA 治疗的患者在停止治疗后很少发生病毒学或临床复发。
