依泽替米贝治疗十二周对慢性D型肝炎患者HDV RNA水平的影响

StephenW

Turk J Gastroenterol. 2020 Feb;31(2):136-141. doi: 10.5152/tjg.2020.18846.
The effect of twelve weeks of treatment with ezetimibe on HDV RNA level in patients with chronic hepatitis D.
Abbas Z1, Saad M1, Asim M1, Abbas M1, Samejo SA1.
Author information

1
    Department of Hepato-Gastroenterology, Dr. Ziauddin University Hospital Clifton, Karachi, Pakistan.

Abstract
BACKGROUND/AIMS:

Sodium taurocholate co-transporting polypeptide (NTCP) is the receptor for the hepatitis B virus (HBV) and hepatitis D virus (HDV) entry into hepatocytes. Ezetimibe is a cholesterol-lowering drug that possesses the pharmacophore features to inhibit NTCP. This study evaluates the efficacy of ezetimibe in patients with chronic HDV infection in a nonrandomized trial.
MATERIALS AND METHODS:

This proof of concept phase 2 trial evaluated the efficacy and safety of ezetimibe 10 mg daily in (interferon treatment-experienced or interferon ineligible) patients with chronic hepatitis D (CHD). Forty-four patients with CHD were recruited, 38 male and 6 female patients, mean age 35.2±8.7 (range 19-64). Fifteen (34%) patients were on concomitant nucleoside therapy, and cirrhosis was present in 14 subjects. The primary therapeutic endpoint was a decline in HDV RNA at one log or more from the baseline at week 12.
RESULTS:

The mean HDV RNA level was 5.4±1.3 log10 IU/mL. HBeAg was non-reactive in 43 (98%). HBV DNA was undetectable in 28 (64%). One patient stopped treatment at week 4, and one patient did not follow-up. One log or more reduction in the HDV RNA levels was observed in 18/44 (41%) patients. No log reduction occurred in 16 patients, and 8 experienced a log increase. No adverse effects from the concomitant nucleoside analogue use or clinical cirrhosis were observed. The drug exhibited a positive safety profile.
CONCLUSION:

Treatment of CHD patients with ezetimibe resulted in a one log reduction of viral load in 43% (18/42) of the patients who completed the 12 weeks of therapy.

PMID:
    32141822
DOI:
    10.5152/tjg.2020.18846

StephenW

土耳其人J胃肠。 2020 Feb; 31（2）：136-141。 doi：10.5152 / tjg.2020.18846。
依泽替米贝治疗十二周对慢性D型肝炎患者HDV RNA水平的影响。
阿巴斯Z1，萨阿德M1，阿西姆M1，阿巴斯M1，Samejo SA1。
作者信息

1个
    齐奥丁大学附属医院，卡拉奇，克利夫顿，肝消化科。

抽象
背景/目的：

牛磺胆酸钠共转运多肽（NTCP）是乙型肝炎病毒（HBV）和丁型肝炎病毒（HDV）进入肝细胞的受体。依泽替米贝是一种降低胆固醇的药物，具有抑制NTCP的药效团特征。这项研究在一项非随机试验中评估了依折麦布在慢性HDV感染患者中的疗效。
材料和方法：

这项概念验证的2期临床试验评估了每天10 mg依泽替米贝在（患有干扰素治疗或无干扰素治疗的）慢性D型肝炎（CHD）患者中的疗效和安全性。招募了44例冠心病患者，男性38例，女性6例，平均年龄35.2±8.7（范围19-64）。 15例（34％）患者同时接受核苷治疗，14例患者出现肝硬化。主要治疗终点是第12周时HDV RNA从基线下降了一个log或更多。
结果：

HDV RNA的平均水平为5.4±1.3 log10 IU / mL。 HBeAg在43例中无反应（98％）。在28（64％）人中未检测到HBV DNA。一名患者在第4周停止治疗，一名患者未进行随访。在18/44（41％）患者中，HDV RNA水平降低了一个log或更多。 16名患者未发生对数减少，其中8名经历了对数增加。没有观察到伴随使用核苷类似物或临床肝硬化的不良反应。该药物显示出积极的安全性。
结论：

接受依泽替米贝治疗的CHD患者在完成12周治疗的患者中有43％（18/42）的患者病毒载量减少了一个对数。

PMID：
    32141822
DOI：
    10.5152 / tjg.2020.18846