病毒抑制和肝硬化回归与富马酸替诺福韦酯在亚洲人慢性乙

StephenW

Digestive Diseases and Sciences
January 2015, Volume 60, Issue 1, pp 260-268
Date: 02 Sep 2014
Viral Suppression and Cirrhosis Regression with Tenofovir Disoproxil Fumarate in Asians with Chronic Hepatitis B

    Naoky C. Tsai,
    Patrick Marcellin,
    Maria Buti,
    Mary Kay Washington,
    Samuel S. Lee,
    Sing Chan,
    Huy Trinh,
    John F. Flaherty,
    Kathryn M. Kitrinos,
    Phillip Dinh,
    … show all 13


Abstract
Background

Chronic hepatitis B (CHB) is a major public health concern, particularly in endemic areas like Asia–Pacific. Sustained virologic suppression correlates with regression of histologic fibrosis and cirrhosis.
Aim

This study evaluated efficacy and safety of tenofovir disoproxil fumarate (TDF) in Asian patients through 240 weeks of treatment.
Methods

Post hoc analysis of the Asian subpopulation from two phase 3 clinical studies was performed. Following a 48-week randomized, double-blind evaluation of once-daily TDF versus once-daily adefovir dipivoxil, open-label TDF for up to 240 weeks was evaluated. Patients with both baseline and week 240 liver biopsies were evaluated for histologic changes.
Results

At baseline, 189/641 (29 %) patients randomized were Asian. Sixty-eight percent of Asian patients were male; 50 % were hepatitis B e antigen (HBeAg)-positive. At week 240, similar proportions of Asian (88 %) and non-Asian (87 %) patients demonstrated improvement in liver histology, and 19/22 (86 %) Asian patients with baseline cirrhosis were no longer cirrhotic. By modified intent-to-treat analysis, 74 % of Asian patients and 76 % of non-Asian patients had HBV DNA <400 copies/mL at the end of week 240 (P = 0.602). No differences were seen in HBeAg loss or seroconversion in Asian versus non-Asian patients. No Asian patient experienced hepatitis B surface antigen loss. Safety and tolerability of TDF through week 240, including changes in renal function and in hip/spine bone mineral density (from weeks 192 to 240), were comparable between Asian and non-Asian patients.
Conclusions

Long-term virologic and histologic efficacy and safety of TDF are comparable in Asian and non-Asian CHB patients.

StephenW

消化系统疾病和科学
2015年1月，第60卷，第1期，第260-268
日期：2014年9月2日
病毒抑制和肝硬化回归与富马酸替诺福韦酯在亚洲人慢性乙型肝炎

    Naoky C.仔，
    帕特里克Marcellin，
    玛丽亚·布提，
    玫琳凯华盛顿
    塞缪尔·S·李，
    星灿，
    于伊郑氏，
    约翰·弗莱厄蒂，
    凯瑟琳M. Kitrinos，
    菲利普亭，
    ...显示全部13


抽象
背景

慢性乙型肝炎（CHB）是一个主要的公共健康问题，尤其是在流行地区，如亚太。持续病毒学抑制与相关病理纤维化和肝硬化的回归。
目的

到240周的治疗，这项研究评估疗效和富马酸替诺福韦酯（TDF）安全亚洲患者。
方法：

进行两个3期临床研究亚洲亚群的事后分析。以下一个48周的随机，每日一次TDF的与每日一次阿德福韦酯，开放标签TDF长达240周双盲评价进行评价。患者的基线和每周240肝活检进行了评估组织学改变。
结果

在基线，641分之189（29％）的患者随机是亚裔。亚洲患者的百分之六十八是男性; 50％是乙肝e抗原（HBeAg）阳性。在240周，亚（88％）和非亚洲（87％）的患者的相似的比例表现出改善的肝组织学和19/22（86％），亚洲患者与基线肝硬化不再肝硬化。通过改良的意向性治疗分析，74％的亚洲病人和非亚洲患者中76％有HBV DNA<400拷贝/毫升，在240周（P =0.602）结束。无差异主要出现在大三阳亚洲损失或血清学转换与非亚裔患者。没有亚洲病人经验的乙肝表面抗原的损失。经过240周的安全性和TDF的耐受性，包括肾功能及髋/骨密度的变化（从周192〜240），具有可比性的亚洲和非亚洲患者之间。
结论

长期的病毒学和组织学疗效和TDF安全性具有可比性的亚洲和非亚洲慢性乙肝患者。