Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, Sichuan, China.
J Med Virol. 2020 Mar;92(3):302-308. doi: 10.1002/jmv.25608. Epub 2019 Oct 29.
The aim of this retrospective study was to compare the efficacy and safety of tenofovir disoproxil fumarate (TDF) monotherapy and TDF + entecavir (ETV) combination therapy for chronic hepatitis B (CHB) patients with the partial virological response (PVR) to ETV.
CHB patients with PVR to ETV were switched to TDF monotherapy or TDF + ETV combination therapy. The primary efficacy outcome was a virological response (VR), and the secondary efficacy outcomes were hepatitis B e antigen (HBeAg) seroconversion and alanine aminotransferase (ALT) normalization. The primary safety outcomes were changes in serum creatinine and serum phosphorus levels.
A total of 143 patients were investigated, including 63 patients in the TDF monotherapy group and 80 patients in the TDF + ETV combination therapy group. Baseline demographics and clinical characteristics were comparable between groups. The median age of patients was 44.5 years, and 76.2% of them were male. The VR rate in TDF + ETV group was higher than that of the TDF group at 48 weeks (88.8% vs 71.4%; P = .009). At 48 weeks, the HBeAg seroconversion rate of TDF + ETV group was higher than that of the TDF group (30% vs 15.9%; P = .049). There was no significant difference in the proportion of patients with elevated ALT in the TDF group and TDF + ETV group at 48 weeks (9.5% vs 7.5%; P = .665). After adjusting the treatment regimen, serum creatinine levels increased slightly and serum phosphorus level decreased slightly in both groups.
TDF + ETV combination therapy for 48 weeks had a higher VR rate than TDF monotherapy in CHB patients with PVR to ETV.
本回顾性研究旨在比较替诺福韦酯（TDF）单药治疗和 TDF+恩替卡韦（ETV）联合治疗对 ETV 部分病毒学应答（PVR）的慢性乙型肝炎（CHB）患者的疗效和安全性。
对 ETV 部分病毒学应答的 CHB 患者转换为 TDF 单药治疗或 TDF+ETV 联合治疗。主要疗效终点为病毒学应答（VR），次要疗效终点为乙型肝炎 e 抗原（HBeAg）血清学转换和丙氨酸氨基转移酶（ALT）正常化。主要安全性终点为血清肌酐和血清磷水平的变化。
共纳入 143 例患者，其中 TDF 单药治疗组 63 例，TDF+ETV 联合治疗组 80 例。两组患者的基线人口统计学和临床特征相似。患者的中位年龄为 44.5 岁，76.2%为男性。TDF+ETV 组的 VR 率在 48 周时高于 TDF 组（88.8%比 71.4%；P=0.009）。48 周时，TDF+ETV 组的 HBeAg 血清学转换率高于 TDF 组（30%比 15.9%；P=0.049）。48 周时，TDF 组和 TDF+ETV 组的 ALT 升高患者比例无显著差异（9.5%比 7.5%；P=0.665）。调整治疗方案后，两组患者的血清肌酐水平略有升高，血清磷水平略有下降。
在 ETV 部分病毒学应答的 CHB 患者中，TDF+ETV 联合治疗 48 周的 VR 率高于 TDF 单药治疗。
