Details

Autor(en) / Beteiligte

• Matsumoto, Akihiro
• Nishiguchi, Shuhei
• Enomoto, Hirayuki
• Tanaka, Yasuhito
• Shinkai, Noboru
• Okuse, Chiaki
• Kang, Jong-Hon
• Matsui, Takeshi
• Miyase, Shiho
• Yatsuhashi, Hiroshi
• Nagaoka, Shinya
• Kanda, Tatsuo
• Enomoto, Masaru
• Yamada, Ryoko
• Hiramatsu, Naoki
• Saito, Satoru
• Takaguchi, Koichi
• Ito, Kiyoaki
• Masaki, Tsutomu
• Morihara, Daisuke
• Tsuge, Masataka
• Chayama, Kazuaki
• Ikeda, Fusao
• Kagawa, Tatehiro
• Kondo, Yasuteru
• Murata, Kazumoto
• Tanaka, Eiji

Titel

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

Ist Teil von

• Journal of gastroenterology, 2020-10, Vol.55 (10), p.977-989

Ort / Verlag

Singapore: Springer Singapore

Erscheinungsjahr

2020

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• 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). 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. 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. 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.