■有限的数据已经报道了使用聚乙二醇干扰素(PEG-IFN)α-2b治疗产后乙型肝炎e抗原(HBeAg)阴性女性慢性乙型肝炎病毒(HBV)感染。这项研究是评估PEG-IFNα-2b在HBV产后妇女无HBeAg的有效性和安全性,并确定与功能治愈相关的因素。
■共有150例HBeAg阴性产后妇女回顾性招募。47例患者接受PEG-IFNα-2b[PEG-IFN(+)组]和103例患者没有[PEG-IFN(-)组]。采用倾向评分匹配法(PSM)调整两组基线失衡。随访患者至少48周。主要终点是48周时的乙型肝炎表面抗原(HBsAg)丢失和HBsAg血清转换。采用Logistic回归分析评估48周时HBsAg消失的相关因素。
■在第48周时,Peg-IFN(+)组的HBsAg消失和血清转换率分别为51.06%(24/47)和40.43%(19/47),分别。即使在PSM之后,PEG-IFN(+)组仍显示较高的HBsAg损失率(50.00%vs7.14%,p<0.001)和更高的HBsAg血清转换率(38.10%vs2.38%,p<0.001)。基线HBsAg水平(赔率比[OR]:0.051,95%置信区间[CI]:0.003-0.273,P=0.010),HBsAg在第24周(OR:0.214,95CI:0.033-0.616,P=0.022),第24周HBsAg下降(OR:4.682,95CI:1.624-30.198,P=0.022)和产后耀斑(OR:21.181,95CI:1.872-633.801,P=0.030)与PEG-IFNα-2b治疗后第48周的HBsAg消失显着相关。此外,受试者工作特征曲线(ROC)显示,使用基线HBsAg<182IU/mL,HBsAg在第24周<4IU/mL和HBsAg下降在第24周>12IU/mL是HBsAg消失的良好预测因子。未报告严重不良事件。
■PEG-IFNα-2b治疗可以实现HBsAg丢失和HBeAg阴性产后妇女血清转换的高比率,具有可靠的安全性,特别是对于经历产后耀斑和基线HBsAg水平低的患者。
UNASSIGNED: Limited data have been reported on achieving functional cure using pegylated interferon (Peg-IFN) alpha-2b treatment for postpartum hepatitis B e antigen (HBeAg)-negative women with chronic hepatitis B virus (HBV) infection. This study was to assess the effectiveness and safety of Peg-IFN alpha-2b in HBV postpartum women without HBeAg and identify factors linked to the functional cure.
UNASSIGNED: A total of 150 HBeAg-negative postpartum women were retrospectively recruited.47 patients received Peg-IFN alpha-2b [Peg-IFN(+) group] and 103 patients did not [Peg-IFN(-) group]. Propensity score matching (PSM) was used to adjust the baseline imbalance between the two groups. The patients were followed for at least 48 weeks. The primary endpoints were hepatitis B surface antigen(HBsAg) loss and HBsAg
seroconversion at 48 weeks. Logistic regression analysis was used to assess factors associated with HBsAg loss at 48 weeks.
UNASSIGNED: At week 48,the HBsAg loss and
seroconversion rate in Peg-IFN(+) group were 51.06%(24/47) and 40.43%(19/47), respectively. Even after PSM, Peg-IFN(+) group still showed higher HBsAg loss rate (50.00% vs 7.14%,p<0.001) and higher HBsAg
seroconversion rate (38.10% vs 2.38%,p<0.001). Baseline HBsAg levels (Odds Ratio [OR]: 0.051, 95% Confidence Interval [CI]: 0.003-0.273, P=0.010), HBsAg at week 24 (OR:0.214, 95%CI:0.033-0.616, P=0.022), HBsAg decline at week 24 (OR:4.682, 95%CI: 1.624-30.198, P=0.022) and postpartum flare (OR:21.181, 95%CI:1.872-633.801, P=0.030) were significantly associated with HBsAg loss at week 48 after Peg-IFN alpha-2b therapy. Furthermore, the receiver operating characteristic curve (ROC) showed that the use of baseline HBsAg<182 IU/mL, HBsAg at week24 < 4 IU/mL and HBsAg decline at week24>12IU/mL were good predictors of HBsAg loss. No serious adverse events were reported.
UNASSIGNED: Peg-IFN alpha-2b treatment could achieve a high rate of HBsAg loss and
seroconversion in HBeAg-negative postpartum women with reliable safety, particularly for patients experience postpartum flare and have low baseline HBsAg levels.