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Pilot study of tenofovir disoproxil fumarate and pegylated interferon-alpha 2a add-on therapy in Japanese patients with chronic hepatitis B.

Pilot study of tenofovir disoproxil fumarate and pegylated interferon-alpha 2a add-on therapy in Japanese patients with chronic hepatitis B.

Authors :
Matsumoto A
Nishiguchi S
Enomoto H
Tanaka Y
Shinkai N
Okuse C
Kang JH
Matsui T
Miyase S
Yatsuhashi H
Nagaoka S
Kanda T
Enomoto M
Yamada R
Hiramatsu N
Saito S
Takaguchi K
Ito K
Masaki T
Morihara D
Tsuge M
Chayama K
Ikeda F
Kagawa T
Kondo Y
Murata K
Tanaka E
Source :
Journal of gastroenterology [J Gastroenterol] 2020 Oct; Vol. 55 (10), pp. 977-989. Date of Electronic Publication: 2020 Jul 14.
Publication Year :
2020

Abstract

Background: A prospective pilot study of tenofovir disoproxil fumarate (TDF) and pegylated interferon alpha 2a (P-IFN) add-on therapy was conducted to evaluate its efficacy in reducing viral antigen levels in Japanese patients with chronic hepatitis B (UMIN 000020179).<br />Methods: Patients with chronic hepatitis B receiving maintenance TDF therapy and exhibiting hepatitis B surface antigen (HBsAg) level > 800 IU/ml were divided into two arms. P-IFN was added for 48 weeks in the add-on arm (n = 32), while TDF monotherapy was maintained in the control arm (n = 51). Both groups were followed for 96 weeks after baseline measurements.<br />Results: Almost all patients in the control arm displayed a slow and constant reduction in HBsAg during follow-up. In contrast, roughly half of the add-on arm exhibited a sharp decline in HBsAg during P-IFN administration, which disappeared after halting P-IFN. At 96 weeks after baseline, 41% (13/32) of patients in the add-on arm had shown a rapid decrease in HBsAg, versus 2% (1/51) in the control arm (p < 0.001). Add-on therapy and increased cytotoxic T-cell response were significant factors associated with a rapid decrease in HBsAg according to multivariate analysis. In addition, higher HB core-related antigen (HBcrAg) level at baseline (p = 0.001) and add-on therapy (p = 0.036) were significant factors associated with a rapid reduction in HBcrAg.<br />Conclusions: TDF and P-IFN add-on therapy in Japanese patients with chronic hepatitis B facilitated rapid decreases in HBsAg and HBcrAg. Further studies are needed to improve early HBsAg clearance rate.

Details

Language :
English
ISSN :
1435-5922
Volume :
55
Issue :
10
Database :
MEDLINE
Journal :
Journal of gastroenterology
Publication Type :
Academic Journal
Accession number :
32666202
Full Text :
https://doi.org/10.1007/s00535-020-01707-6