Department of Liver Disease, Shanghai Public Health Clinical Center, Fudan University, 2901 Cao Lang Road, Shanghai, 201508, China.
Department of Infectious Disease, Huashan Hospital, Fudan University, Shanghai, China.
Hepatol Int. 2021 Feb;15(1):51-59. doi: 10.1007/s12072-020-10095-1. Epub 2020 Sep 29.
This study aimed to evaluate the efficacy of Peg-interferon (Peg-IFN)-nucleoside analog (NA) sequential optimization therapy (SOT) in HBeAg-positive patients with chronic hepatitis B (CHB).
In this prospective two-center study, 132 CHB patients were assigned to receive Peg-IFN standard therapy for 48 weeks (65 patients) or Peg-IFN monotherapy for 12-24 weeks and NA add-on for those without early virological response (EVR) (67 patients). Both patient groups were monitored and followed for 24 weeks after treatments stop.
At week 24 after treatments stop, the Peg-IFN-NA SOT group achieved more HBsAg levels drop (- 1.35 vs - 0.67 log IU/mL, p = 0.016), higher HBsAg ≤ 100 IU/mL (32.8% vs 9.2%, p = 0.001), HBV DNA undetectable (79.1% vs 49.2%, p < 0.001), and ALT normalization (80.6% vs 38.5%, p < 0.001) rates compared with Peg-IFN monotherapy. At week 24 after treatments stop, no significant difference was found in HBeAg seroconversion (35.8% vs 27.7%, p = 0.316), HBsAg loss (8.9% vs 4.6%, p = 0.323) and HBsAg seroconversion rates (4.5% vs 1.5%, p = 0.325) between Peg-IFN monotherapy group and Peg-IFN-NA SOT group.
Starting with Peg-IFN followed by addition of NA achieved more HBsAg levels drop, and higher HBsAg ≤ 100 IU/mL, HBV DNA undetectable, and ALT normalization rates compared with Peg-IFN monotherapy.
本研究旨在评估聚乙二醇干扰素（Peg-IFN）-核苷（酸）类似物（NA）序贯优化治疗（SOT）在 HBeAg 阳性慢性乙型肝炎（CHB）患者中的疗效。
在这项前瞻性的双中心研究中，132 例 CHB 患者被分配接受 Peg-IFN 标准治疗 48 周（65 例）或 Peg-IFN 单药治疗 12-24 周，对于无早期病毒学应答（EVR）的患者加用 NA（67 例）。两组患者在治疗停止后均监测和随访 24 周。
治疗停止后 24 周，Peg-IFN-NA SOT 组 HBsAg 水平下降更多（-1.35 与-0.67 log IU/mL，p=0.016），HBsAg≤100 IU/mL 的比例更高（32.8%与 9.2%，p=0.001），HBV DNA 不可检测的比例更高（79.1%与 49.2%，p<0.001），ALT 正常化的比例更高（80.6%与 38.5%，p<0.001），与 Peg-IFN 单药治疗相比。治疗停止后 24 周，Peg-IFN 单药治疗组和 Peg-IFN-NA SOT 组之间 HBeAg 血清学转换率（35.8%与 27.7%，p=0.316）、HBsAg 丢失率（8.9%与 4.6%，p=0.323）和 HBsAg 血清学转换率（4.5%与 1.5%，p=0.325）均无显著差异。
与 Peg-IFN 单药治疗相比，先用 Peg-IFN 再联用 NA 可使 HBsAg 水平下降更多，HBsAg≤100 IU/mL、HBV DNA 不可检测和 ALT 正常化的比例更高。
