聚乙二醇干扰素α治疗产后妇女慢性乙型肝炎病毒感染的疗效:一项多中心前瞻性研究
Efficacy of pegylated interferon alpha in treating postpartum women with chronic hepatitis B virus infection: a multicenter prospective study.
Efficacy of pegylated interferon alpha in treating postpartum women with chronic hepatitis B virus infection: a multicenter prospective study.
乙型肝炎表面抗原(HBsAg)清除是慢性乙型肝炎病毒(HBV)感染功能性(临床)治愈的关键里程碑。然而,关于聚乙二醇干扰素α(Peg-IFNα)在慢性HBV感染的产后妇女中清除HBsAg的有效性和安全性的数据仍然很少。本研究旨在前瞻性评估Peg-IFNα在促进该特定人群HBsAg清除方面的有效性和安全性。共招募了263名基线HBsAg水平≤3000 IU/mL的HBV感染产后妇女。根据患者的偏好,他们被分配到Peg-IFNα组(n=62,接受Peg-IFN-α单药治疗或与核苷类似物[NA]的联合治疗)或对照组(n=201,仅接受NAs或随访)。Peg-IFNα治疗持续时间≥48周。进行倾向评分匹配(PSM)以平衡基线特征。主要终点是HBsAg清除率和HBsAg下降幅度。在第48周,Peg-IFNα组的HBsAg清除率(29.03%[18/62])和血清转化率(27.42%[17/62])明显高于对照组(均为0%,P<0.001)。PSM后,Peg-IFNα组的HBsAg清除率/血清转化率(30.43%[14/46])仍明显高于对照组(0%,P<0.001)。亚组分析显示,基线HBsAg<1000 IU/mL的患者清除率较高(PSM前:39.02%[16/41];PSM后:40.00%[12/30])。受试者操作特征(ROC)曲线分析表明,从基线到第12周,HBsAg减少≥99.2%是第48周HBsAg清除率的强预测因子(AUC≥0.9;灵敏度=0.818;特异性=1.000)。Peg-IFNα治疗可以在患有慢性HBV感染的产后妇女中实现较高的HBsAg清除率和血清转化率。产后时期是基于干扰素干预的独特而有利的免疫窗口,基线HBsAg<1000 IU/mL的患者从这一策略中获益匪浅。
Hepatitis B surface antigen (HBsAg) clearance is a key milestone for functional (clinical) cure of chronic hepatitis B virus (HBV) infection. However, data on the efficacy and safety of pegylated interferon alpha (Peg-IFNα) for HBsAg clearance in postpartum women with chronic HBV infection remain scarce. This study aimed to prospectively evaluate the efficacy and safety of Peg-IFNα in promoting HBsAg clearance in this specific population. A total of 263 HBV-infected postpartum women with a baseline HBsAg levels ≤3000 IU/mL were enrolled. Based on patient preference, they were assigned to either the Peg-IFNα group (n=62, receiving Peg-IFNα monotherapy or combination therapy with nucleos(t)ide analogs [NAs]) or the control group (n=201, receiving NAs or follow-up only). The duration of Peg-IFNα treatment was ≥48 weeks. Propensity score matching (PSM) was performed to balance baseline characteristics. The primary endpoints were both HBsAg clearance rate and the magnitude of HBsAg decline. At week 48, the Peg-IFNα group had significantly higher HBsAg clearance (29.03% [18/62]) and seroconversion rates (27.42% [17/62]) than the control group (both 0%, P < 0.001). Post-PSM, the Peg-IFNα group still had a significantly higher HBsAg clearance/seroconversion rate (30.43% [14/46]) versus the control group (0%, P < 0.001). Subgroup analysis showed that patients with baseline HBsAg < 1000 IU/mL had higher clearance rates (pre-PSM: 39.02% [16/41]; post-PSM: 40.00% [12/30]). Receiver operating characteristic (ROC) curve analysis identified a ≥ 99.2% HBsAg reduction from baseline to week 12 as a strong predictor of week 48 HBsAg clearance (AUC ≥0.9; sensitivity =0.818; specificity= 1.000). Peg-IFNα treatment can achieve high rates of HBsAg clearance and seroconversion in postpartum women with chronic HBV infection. The postpartum period represents a unique and favorable immune window for interferon-based intervention, and patients with baseline HBsAg <1000 IU/mL derive particular benefit from this strategy.
Hongmei Gong, Ming Liu, Xuqing Zhang, Wei Sun, Hongli Deng, Wei Liu, et al. Efficacy of pegylated interferon alpha in treating postpartum women with chronic hepatitis B virus infection: a multicenter prospective study.. Frontiers in cellular and infection microbiology. 2026; doi:10.3389/fcimb.2026.1802657.
Hongmei Gong, Ming Liu, Xuqing Zhang, Wei Sun, Hongli Deng, Wei Liu, et al (2026). Efficacy of pegylated interferon alpha in treating postpartum women with chronic hepatitis B virus infection: a multicenter prospective study.. Frontiers in cellular and infection microbiology. https://doi.org/10.3389/fcimb.2026.1802657
Hongmei Gong, Ming Liu, Xuqing Zhang, Wei Sun, Hongli Deng, Wei Liu, et al. Efficacy of pegylated interferon alpha in treating postpartum women with chronic hepatitis B virus infection: a multicenter prospective study.[J]. Frontiers in cellular and infection microbiology, 2026 doi:10.3389/fcimb.2026.1802657.
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