韩国初治慢性乙型肝炎患者应用富马酸替诺福韦二吡呋酯的疗效和安全性。
Efficacy and Safety of Tenofovir Disoproxil Fumarate in Treatment-Naïve Patients with Chronic Hepatitis B in Korea.
机构信息
Division of Hepatology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Division of Hepatology, Department of Internal Medicine, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
出版信息
Dig Dis Sci. 2019 Jul;64(7):2039-2048. doi: 10.1007/s10620-019-05489-7. Epub 2019 Feb 6.
AIMS
To evaluate the efficacy and safety of 144-week tenofovir disoproxil fumarate (TDF) therapy in treatment-naïve chronic hepatitis B (CHB) patients in Korean.
METHODS
In total, 579 treatment-naïve CHB patients at 11 medical centers were enrolled retrospective and prospective from September 2015 to January 2016 by design (NCT02533544). We evaluated the complete virologic response (CVR) rate and the renal safety of TDF.
RESULTS
The overall CVR rate was 69.4%, 87.0%, and 89.7% at weeks 48, 96, and 144, respectively. In the HBeAg-positive CHB patients, the CVR rate at weeks 48, 96, and 144 was 61.4%, 83.1%, and 89.6%, respectively. The rates of HBeAg loss and seroconversion at weeks 48, 96, and 144 were 16.6%, 23.5%, 34.1%, and 7.6%, 8.9%, 13.3%, respectively. In HBeAg-negative CHB patients, the CVR rate at weeks 48, 96, and 144 was 82.5%, 93.2%, and 90.0%, respectively. The rate of alanine aminotransferase normalization was 36.9%, 45.4%, and 46.8% at weeks 48, 96, and 144, respectively. Of the CHB patients, 0.9% showed an elevated creatinine (> 0.5 mg/dL from baseline). Age (≥ 60 years) was significantly associated with a decline in renal function at week 144 (P < 0.0001). Comorbidities (diabetes or hypertension) showed the tendency to reduce renal function (P = 0.0624). Hepatocellular carcinoma developed in 10 (1.7%) patients and was related to cirrhosis.
CONCLUSIONS
TDF therapy induced sustained viral suppression and had a favorable safety profile over a 3-year period. However, close monitoring of renal function should be mandatory in treating CHB patients receiving TDF, particularly older patients.
目的
评估替诺福韦酯（TDF）在韩国初治慢性乙型肝炎（CHB）患者中进行 144 周治疗的疗效和安全性。
方法
本研究为回顾性和前瞻性研究，共纳入了 2015 年 9 月至 2016 年 1 月期间来自 11 个医疗中心的 579 例初治 CHB 患者（NCT02533544）。我们评估了 TDF 的完全病毒学应答（CVR）率和肾脏安全性。
结果
总体 CVR 率分别为第 48、96 和 144 周时的 69.4%、87.0%和 89.7%。在 HBeAg 阳性 CHB 患者中，第 48、96 和 144 周时的 CVR 率分别为 61.4%、83.1%和 89.6%。第 48、96 和 144 周时 HBeAg 丢失和血清学转换率分别为 16.6%、23.5%、34.1%和 7.6%、8.9%、13.3%。在 HBeAg 阴性 CHB 患者中，第 48、96 和 144 周时的 CVR 率分别为 82.5%、93.2%和 90.0%。第 48、96 和 144 周时丙氨酸氨基转移酶正常化率分别为 36.9%、45.4%和 46.8%。在 CHB 患者中，有 0.9%的患者出现肌酐升高（较基线升高>0.5mg/dL）。年龄（≥60 岁）与第 144 周时肾功能下降显著相关（P<0.0001）。合并症（糖尿病或高血压）表现出降低肾功能的趋势（P=0.0624）。10 例（1.7%）患者发生肝细胞癌，与肝硬化有关。
结论
TDF 治疗可诱导持续的病毒抑制，在 3 年期间具有良好的安全性。然而，在治疗接受 TDF 治疗的 CHB 患者时，特别是老年患者，应强制性监测肾功能。
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