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. 2021;60(4):507-516.
doi: 10.2169/internalmedicine.5432-20. Epub 2021 Feb 15.

Factors Associated with Hepatitis B Surface Antigen Kinetics and Responses in Pegylated Interferon Alpha-2a Monotherapy for Patients with Chronic Hepatitis B

Norio Itokawa  1 , Masanori Atsukawa  1   2 , Akihito Tsubota  3 , Noritomo Shimada  4 , Hidenori Toyoda  5 , Koichi Takaguchi  6 , Atsushi Hiraoka  7 , Tomonori Senoh  6 , Mai Koeda  1 , Yuji Yoshida  1 , Tomomi Okubo  1 , Taeang Arai  1 , Korenobu Hayama  1 , Ai Nakagawa-Iwashita  1 , Chisa Kondo  2 , Katsuhiko Iwakiri  2
Affiliations

Factors Associated with Hepatitis B Surface Antigen Kinetics and Responses in Pegylated Interferon Alpha-2a Monotherapy for Patients with Chronic Hepatitis B

Norio Itokawa et al. Intern Med. 2021.

Abstract

Objective Pegylated-interferon monotherapy is the standard treatment for patients with chronic hepatitis B; however, the factors associated with its therapeutic effects remain unclear. Methods Patients with chronic hepatitis B were treated with pegylated interferon α-2a for 48 weeks. We evaluated the kinetics of hepatitis B surface antigen (HBsAg) during treatment and follow-up periods and the factors associated with an HBsAg response (defined as a change in HBsAg of ≥-1 log IU/mL from baseline). Results The study population comprised 50 patients. The median baseline levels of hepatitis B virus DNA and HBsAg were 5.00 and 3.40 log IU/mL. The median values of HBsAg reduction from baseline were -0.44 (n=48), -0.41 (n=40), and -0.68 (n=11) log IU/mL at the end of treatment and at 48 and 144 weeks post-treatment, respectively. The rates of HBsAg response were 24.0% and 22.5% at the end of treatment and at 48 weeks post-treatment, respectively. A multivariate analysis identified HBsAg <3.00 log IU/mL as an independent baseline factor contributing to the HBsAg response at the end of treatment and 48 weeks post-treatment (p=1.07×10-2 and 4.42×10-2, respectively). There were significant differences in the reduction of the HBsAg levels at 12 weeks of treatment and in the incidence of serum ALT increase during treatment between patients with and without an HBsAg response. Conclusion These findings suggest that the baseline HBsAg level, HBsAg kinetics at 12 weeks of treatment, and ALT increase during treatment are important factors contributing to the HBsAg response in pegylated interferon α-2a monotherapy for patients with chronic hepatitis B.

Keywords: HBsAg response; hepatitis B surface antigen (HBsAg) kinetics; pegylated interferon alpha-2a monotherapy.

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Conflict of interest statement

The authors state that they have no Conflict of Interest (COI).

Figures

Figure 1.
Figure 1.
Treatment responses in patients treated with Peg-IFNα-2a monotherapy. (a) HBsAg kinetics during the treatment and post-treatment periods; HBsAg levels gradually decreased during the treatment and follow-up periods. (b) Treatment responses (HBsAg response, virological response, and biochemical response) at the end of treatment and 48 weeks post-treatment. Peg-IFNα-2a: pegylated interferon α-2a, HBsAg: hepatitis B surface antigen
Figure 2.
Figure 2.
HBsAg kinetics according to baseline factors. (a) Gender, (b) age (c) HBeAg positivity, (d) HBV DNA genotypes, (e) HBV DNA levels, and (f) HBsAg levels. HBeAg: hepatitis B envelope antigen, HBsAg: hepatitis B surface antigen
Figure 3.
Figure 3.
The comparison of HBsAg kinetics during Peg-IFNα-2a monotherapy between HBsAg responders and non-responders. Significant differences between HBsAg responders and non-responders were noted at 12 weeks of treatment and increased with time. Peg-IFNα-2a: pegylated interferon α-2a, HBsAg: hepatitis B surface antigen
Figure 4.
Figure 4.
A comparison of the time-course changes in serum ALT levels and the prevalence of ALT increase during Peg-IFNα-2a monotherapy between HBsAg responders and non-responders. Serum ALT levels in HBsAg responders were more elevated than those in HBsAg non-responder. The proportion of ALT increase during treatment for HBsAg responders was significantly higher than that in HBsAg non-responders. ALT: alanine aminotransferase, Peg-IFNα-2a: pegylated interferon α-2a, HBsAg: hepatitis B surface antigen
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