聚乙二醇干扰素α-2a在慢性乙型肝炎患者中国际观察性S-Collat

StephenW

PLoS One. 2020 Apr 10;15(4):e0230893. doi: 10.1371/journal.pone.0230893. eCollection 2020.
Final analysis of the international observational S-Collate study of peginterferon alfa-2a in patients with chronic hepatitis B.
Marcellin P1, Xie Q2, Woon Paik S3, Flisiak R4, Piratvisuth T5, Petersen J6, Asselah T1, Cornberg M7, Ouzan D8, Foster GR9, Papatheodoridis G10, Messinger D11, Regep L12, Bakalos G13, Alshuth U14, Lampertico P15, Wedemeyer H7.
Author information
Abstract
BACKGROUND AND AIMS:

Sustained off-treatment immune control is achievable in a proportion of patients with chronic hepatitis B treated with peginterferon alfa-2a. We evaluated on-treatment predictors of hepatitis B surface antigen (HBsAg) clearance 3 years after peginterferon alfa-2a treatment and determined the incidence of hepatocellular carcinoma.
METHODS:

A prospective, international, multicenter, observational study in patients with chronic hepatitis B who have been prescribed peginterferon alfa-2a (40KD) in a real-world setting. The primary endpoint was HBsAg clearance after 3 years' follow-up.
RESULTS:

The modified intention-to-treat population comprised 844 hepatitis B e antigen (HBeAg)-positive patients (540 [64%] completed 3 years' follow-up), and 872 HBeAg-negative patients (614 [70%] completed 3 years' follow-up). At 3 years' follow-up, HBsAg clearance rates in HBeAg-positive and HBeAg-negative populations, respectively, were 2% (16/844) and 5% (41/872) in the modified intention-to-treat population and 5% [16/328] and 10% [41/394] in those with available data. In HBeAg-positive patients with data, Week 12 HBsAg levels <1500, 1500-20,000, and >20,000 IU/mL were associated with HBsAg clearance rates at 3 years' follow-up of 11%, 1%, and 5%, respectively (Week 24 predictability was similar). In HBeAg-negative patients with available data, a ≥10% decline vs a <10% decline in HBsAg at Week 12 was associated with HBsAg clearance rates of 16% vs 4%. Hepatocellular carcinoma incidence was lower than REACH-B (Risk Estimation for Hepatocellular Carcinoma in Chronic Hepatitis B) model predictions.
CONCLUSIONS:

Sustained off-treatment immune control is achieved with peginterferon alfa-2a in a real-world setting. HBsAg clearance 3 years after completion of peginterferon alfa-2a can be predicted on the basis of on-treatment HBsAg kinetics.

PMID:
    32275726
DOI:
    10.1371/journal.pone.0230893

StephenW

PLoS一。 2020年4月10日; 15（4）：e0230893。 Doi：10.1371 / journal.pone.0230893。 ECollection 2020。
聚乙二醇干扰素α-2a在慢性乙型肝炎患者中国际观察性S-Collat​​e研究的最终分析。
Marcellin P1，Xie Q2，Woon Paik S3，Flisiak R4，Piratvisuth T5，Petersen J6，Asselah T1，Cornberg M7，Ouzan D8，Foster GR9，Papatheodoridis G10，Messinger D11，Regep L12，Bakalos G13，Alshuth U14，Lampertico P14。
作者信息
抽象
背景与目的：

接受peginterferon alfa-2a治疗的一部分慢性乙型肝炎患者可以实现持续的脱发免疫控制。我们评估了聚乙二醇干扰素α-2a治疗3年后乙型肝炎表面抗原（HBsAg）清除率的治疗预测指标，并确定了肝细胞癌的发生率。
方法：

对已在现实环境中接受peginterferon alfa-2a（40KD）处方的慢性乙型肝炎患者的前瞻性，国际，多中心观察性研究。主要终点是随访3年后的HBsAg清除率。
结果：

改良的意向性治疗人群包括844名乙肝e抗原（HBeAg）阳性患者（540名[64％]完成3年的随访）和872名HBeAg阴性患者（614名[70％]完成3年的随访） '跟进）。在3年的随访中，改良的意向性治疗人群中HBeAg阳性和HBeAg阴性人群的HBsAg清除率分别为2％（16/844）和5％（41/872）。有可用数据的百分比为[16/328]和10％[41/394]。在有数据的HBeAg阳性患者中，在3年的随访中，第12周HBsAg水平<1500、1500-20,000和> 20,000 IU / mL与HBsAg清除率分别相关（第24周的可预测性相似）。在有可用数据的HBeAg阴性患者中，第12周HBsAg下降≥10％而下降<10％与HBsAg清除率分别为16％和4％相关。肝细胞癌发病率低于REACH-B（慢性乙型肝炎肝细胞癌风险评估）模型预测。
结论：

在实际环境中使用聚乙二醇干扰素α-2a可以实现持续的脱发免疫控制。可以根据治疗中的HBsAg动力学预测peginterferon alfa-2a完成后3年的HBsAg清除率。

PMID：
32275726
DOI：
10.1371 / journal.pone.0230893

StephenW

https://journals.plos.org/ploson ... ournal.pone.0230893

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