Itokawa Norio, Atsukawa Masanori, Tsubota Akihito, Takaguchi Koichi, Nakamuta Makoto, Hiraoka Atsushi, Kato Keizo, Abe Hiroshi, Mikami Shigeru, Shimada Noritomo, Chuma Makoto, Akito Nozaki, Uojima Haruki, Ogawa Chikara, Asano Toru, Tani Joji, Morishita Asahiro, Senoh Tomonori, Yamashita Naoki, Oikawa Tsunekazu, Matsumoto Yoshihiro, Koeda Mai, Yoshida Yuji, Tanabe Tomohide, Okubo Tomomi, Arai Taeang, Hayama Korenobu, Iwashita Ai-Nakagawa, Kondo Chisa, Tada Toshifumi, Toyoda Hidenori, Kumada Takashi, Iwakiri Katsuhiko
Department of Internal Medicine, Division of Gastroenterology Nippon Medical School Chiba Hokusoh Hospital Chiba Japan.
Department of Internal Medicine, Division of Gastroenterology and Hepatology Nippon Medical School Tokyo Japan.
JGH Open. 2020 Nov 2;5(1):34-40. doi: 10.1002/jgh3.12443. eCollection 2021 Jan.
Although tenofovir alafenamide (TAF), as well as entecavir (ETV), is widely used as first-line treatment for patients with chronic hepatitis B, there are only a few studies comparing sequential therapy from ETV to TAF and continuous ETV monotherapy in patients with maintained virologic response to ETV.
In a retrospective multicenter study, we investigated the efficacy and safety of sequential therapy from ETV to TAF (ETV-TAF group) and compared them with continuous ETV monotherapy (ETV group), using propensity score matching, in chronic hepatitis B patients.
From 442 patients, we analyzed 142 patients from each group comprising 71 patients matched for several data, including age, HBV genotype, hepatitis B envelope antigen, cirrhosis, alanine aminotransferase, platelet count, prior ETV monotherapy period, and hepatitis B surface antigen (HBsAg) change during prior ETV monotherapy. In the ETV-TAF group, HBsAg levels significantly decreased from baseline to 48 weeks after switching to TAF (-0.02 log IU/mL, = 0.038). HBcrAg levels also significantly decreased after switching to TAF (-0.1 log IU/mL, = 0.004). However, there were no significant differences in the reduction of HBsAg and HBcrAg levels between the ETV-TAF and ETV groups. There was no significant difference in the change of estimated glomerular filtration rate levels from baseline to 48 weeks between the two groups.
The present study indicated that the efficacy, especially of the HBsAg-reducing action, and safety of sequential therapy from ETV to TAF were similar to those of continuous ETV monotherapy among chronic hepatitis B patients with maintained virologic response to ETV.
虽然替诺福韦艾拉酚胺（TAF）以及恩替卡韦（ETV）均被广泛用作慢性乙型肝炎患者的一线治疗药物，但仅有少数研究比较了在对ETV保持病毒学应答的患者中从ETV转换为TAF的序贯治疗与持续ETV单药治疗的效果。
在一项回顾性多中心研究中，我们采用倾向得分匹配法，调查了从ETV转换为TAF的序贯治疗（ETV-TAF组）的疗效和安全性，并将其与持续ETV单药治疗（ETV组）进行比较，研究对象为慢性乙型肝炎患者。
在442例患者中，我们分析了每组142例患者，其中每组各有71例患者在年龄、HBV基因型、乙肝e抗原、肝硬化、丙氨酸转氨酶、血小板计数、既往ETV单药治疗疗程以及既往ETV单药治疗期间乙肝表面抗原（HBsAg）变化等多项数据上进行了匹配。在ETV-TAF组中，转换为TAF后从基线至48周时，HBsAg水平显著下降（-0.02 log IU/mL，P = 0.038）。转换为TAF后，乙肝核心相关抗原（HBcrAg）水平也显著下降（-0.1 log IU/mL，P = 0.004）。然而，ETV-TAF组与ETV组在HBsAg和HBcrAg水平降低方面无显著差异。两组从基线至48周时估算肾小球滤过率水平的变化无显著差异。
本研究表明，在对ETV保持病毒学应答的慢性乙型肝炎患者中，从ETV转换为TAF的序贯治疗的疗效，尤其是降低HBsAg的作用，以及安全性与持续ETV单药治疗相似。
