聚乙二醇干扰素与恩替卡韦联合治疗改善乙肝e抗原阳性非早期应答患者的预后。

Peginterferon and Entecavir Combination Therapy Improves Outcome of Non-Early Response Hepatitis B e Antigen-Positive Patients.

作者信息

Chen Lu, Lin Lanyi, Zhou Huijuan, Tang Weiliang, Wang Hui, Cai Wei, Bao Shisan, Guo Simin, Xie Qing

机构信息

Department of Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Discipline of Pathology, School of Medical Science, Charles Perkins Centre, The Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.

出版信息

Open Forum Infect Dis. 2020 Sep 30;7(11):ofaa462. doi: 10.1093/ofid/ofaa462. eCollection 2020 Nov.

BACKGROUND

The efficacy of nucleot(s)ide analogs (NAs) and pegylated interferon (PegIFN) combination therapy for hepatitis B e antigen-positive (HBeAg) patients is still controversial. Whether PegIFN and entecavir (ETV) combination therapy could provide a greater benefit for HBeAg patients was assessed.

METHODS

Treatment-naïve HBeAg patients initiated on PegIFN alfa-2a (PegIFNα-2a) for 24 weeks without early response (early response: HBsAg <1500 IU/mL and hepatitis B virus [HBV] DNA <10 copies/mL) were recruited in the current study. Among total of 94 patients, 51 were continued on PegIFNα-2a monotherapy, and 43 were offered PegIFNα-2a and ETV combined therapy.

RESULTS

Better outcomes in response to the combined therapy, compared with that of the monotherapy, were demonstrated, including more HBsAg decline and loss and HBV DNA decline and HBeAg clearance. Importantly, the patients with HBsAg levels between 1500 and 20000 IU/mL initially or between 5000 and 20000 IU/mL after 24 weeks of PegIFNα-2a benefitted more from the combined therapy, compared with those on monotherapy.

CONCLUSIONS

Combined therapy of PegIFNα-2a and ETV is more efficacious for HBeAg patients without early response to PegIFN monotherapy, and HBsAg levels are a good predictor of treatment outcomes.

背景

核苷（酸）类似物（NAs）与聚乙二醇干扰素（PegIFN）联合治疗对乙肝e抗原阳性（HBeAg）患者的疗效仍存在争议。本研究评估了PegIFN与恩替卡韦（ETV）联合治疗是否能为HBeAg患者带来更大益处。

方法

本研究招募了初治的HBeAg患者，这些患者接受聚乙二醇干扰素α-2a（PegIFNα-2a）治疗24周且无早期应答（早期应答定义为：HBsAg<1500 IU/mL且乙肝病毒[HBV] DNA<10拷贝/mL）。在总共94例患者中，51例继续接受PegIFNα-2a单药治疗，43例接受PegIFNα-2a与ETV联合治疗。

结果

与单药治疗相比，联合治疗显示出更好的疗效，包括更多的HBsAg下降和消失、HBV DNA下降以及HBeAg清除。重要的是，初始HBsAg水平在1500至20000 IU/mL之间或在接受PegIFNα-2a治疗24周后HBsAg水平在5000至20000 IU/mL之间的患者，与接受单药治疗的患者相比，从联合治疗中获益更多。