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

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

Lu Chen  1 , Lanyi Lin  1 , Huijuan Zhou  1 , Weiliang Tang  1 , Hui Wang  1 , Wei Cai  1 , Shisan Bao  2 , Simin Guo  1 , Qing Xie  1
Affiliations

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

Lu Chen et al. Open Forum Infect Dis. .

Erratum in

Abstract

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 <105 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 20 000 IU/mL initially or between 5000 and 20 000 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.

Keywords: antiviral treatment; chronic hepatitis B; interferon; nucleos(t)ide analogues.

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Figures

Figure 1.
Figure 1.
Treatment protocol of the study. Abbreviation: ETV, entecavir.
Figure 2.
Figure 2.
Flowchart of the study. Abbreviation: AE, adverse event.
Figure 3.
Figure 3.
The effect of HBsAg in the study. A, The HBsAg decline of the 2 groups from 0 to 96 weeks and 24 weeks post-EOT. B, The HBsAg value of the 2 groups at 48 and 96 weeks. C, HBsAg decline of the 2 groups with 48 and 96 weeks of treatment. Abbreviation: EOT, end of treatment.
Figure 4.
Figure 4.
Comparison of HBeAg clearance and HBV DNA decline/loss between the 2 groups. A, HBeAg clearance of the 2 groups at 96 weeks. B, HBV DNA decline of the 2 groups from week 0 to 96 weeks. C, HBV DNA clearance at 96 weeks of the 2 groups. Abbreviation: EOT, end of treatment.
Figure 5.
Figure 5.
Percentage of patients with HBsAg loss and HBeAg conversion at different time points. A, Percentage of patients with HBsAg loss at different time points. B, Percentage of patients with HBeAg conversion at different time points. Abbreviation: EOT, end of treatment.
Figure 6.
Figure 6.
The prediction value of HBsAg at 0 and 24 weeks. A, The response rate of all patients at 96 weeks with different HBsAg levels at 0 weeks. B, The response rate of patients in the 2 groups at 96 weeks with different HBsAg levels at 0 weeks. C, The response rate of patients in the 2 groups at 96 weeks with different HBsAg levels at 24 weeks. Abbreviation: HBV, hepatitis B virus.
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