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标题: [AASL2015](1997)标准VS低剂量替诺福韦的随机研究 [打印本页]

作者: StephenW 时间: 2015-10-5 16:37 标题: [AASL2015](1997)标准VS低剂量替诺福韦的随机研究

1997
A randomized study of standard vs low-dose tenofovir
for the treatment of chronic hepatitis B
Aline Le Cleach, Genevieve Huard, Claire Fournier, Bernard E.
Willems, Jean-Pierre Villeneuve; Medicine, CHUM, Montreal, QC,
Canada
Tenofovir and entecavir are the most commonly used drugs for
HBV treatment. Because of the very long elimination half-life of
tenofovir active metabolite, we hypothesized that a reduced
dosage of tenofovir might be as effective as standard dosage,
while being less costly. Aims: Evaluate the impact of a standard
(300 mg PO daily) vs reduced (300 mg PO three times a week)
tenofovir posology on HBV viral suppression and renal function.
Methods: Before inclusion, all patients were on a 300 mg
id tenofovir dosage and had an undetectable HBV viral load
(VL). Patients were randomly assigned (1:1) to either continue
tenofovir 300 mg id or reduce dosing to 300 mg three times
a week. Laboratory data were obtained at baseline and every
three months during the study. HBV relapse was defined as a
VL ≥ 2000 IU/ml. Significant chronic kidney disease (CKD)
was defined has a glomerular filtration rate (GFR) ≤ 50 ml/
min. HBeAg seroconversion was defined as the loss of HBeAg
and development of anti-Hbe antibodies (Ab). The study period
extended from 31/05/2010 to 30/04/2015. Results: Thirty-
four patients were included in the study (17 in the standard
and 17 in the reduced tenofovir posology). The majority were
male (28/34, 82.4%) and non-white (18/34, 52.9%) and the
median age was 52 years (IQR 17). The median FU duration
was 63 months (IQR 49). At baseline, the median GFR was 97
ml/min (IQR 31). During FU, one (5.9%) patient in the standard
tenofovir group vs 0 in the reduced dosage group experienced
a HBV relapse. In this patient, the HBV relapse occurred
after 32.1 months was related to an admitted noncompliance
to the medication. No predictive factors of HBV relapse could
be identified upon univariate analyses. HBeAg seroconversion
occurred in one patient in the reduced posology group after
24.7 months. Two patients (one in each group) developed
significant CKD during FU after 9.2 and 25.2 months, respectively.
No predictive factors for the development of significant
CKD could be identified upon univariate analyses. However, in
univariate and multivariate analysis, standard tenofovir dosage
was identified as a predictive factor for lower GFR at the end
of FU (p=0.038). Conclusion: This study suggests that reduced
tenofovir dosage is as effective as standard dosing while being
less costly and appears to confer a protective effect on renal
function.
Disclosures:
Bernard E. Willems - Advisory Committees or Review Panels: Gilead, Vertex,
Behringer-Ingelheim, Abbvie, Roche, Janssen; Grant/Research Support: Gilead,
Vertex, Behringer-Ingelheim, Merck, Cangene, Abbvie; Speaking and Teaching:
Gilead, Janssen
Jean-Pierre Villeneuve - Grant/Research Support: Gilead, Transgene, Immune-
Carta
The following authors have nothing to disclose: Aline Le Cleach, Genevieve
Huard, Claire Fournier

作者: StephenW 时间: 2015-10-5 16:37

1997年
标准VS低剂量替诺福韦的随机研究
对慢性乙型肝炎的治疗
艾琳乐Cleach，吉纳维夫华德，克莱尔富尼耶，伯纳德·E.
威廉姆斯，让 - 皮埃尔·维伦纽夫;医药，密友，蒙特利尔，
加拿大
替诺福韦和恩替卡韦是最常用的药物
乙肝治疗。因为非常长的半衰期的
替诺福韦活性代谢物，我们假设一个减压
替诺福韦的剂量可能是有效的标准剂量，
而被成本更低。目的：评估标准的影响
（300毫克PO每日）比降低（300毫克PO每周三次）
替诺福韦剂量学上的乙肝病毒抑制，肾功能。
方法：纳入之前，所有患者均在300毫克
ID替诺福韦剂量和有一个检测不到乙肝病毒载量
（V L）。患者被随机分配（1:1）到要么继续
替诺福韦300毫克ID或减少加药到300毫克的三倍
一周。实验室数据均在基线和每一个获得
在研究过程中三个月。 HBV的复发被定义为一个
VL≥2000国际单位/毫升。显著慢性肾脏病（CKD）
被定义具有肾小球滤过率（GFR）≤50毫升/
分钟。 HBeAg血清学转换是指HBeAg的损失
和抗HBe抗体（AB）的发展。在研究期间
从延伸至31/05/2010 30/04/2015。结果：三十
4名患者被纳入标准的研究（17
并在减压泰诺福韦剂量学17）。大多数人
雄（28/34，82.4％）和非白色（18/34，52.9％）和
平均年龄为52岁（IQR 17）。平均FU持续时间
为63个月（IQR 49）。在基线，平均GFR为97
毫升/分钟（IQR 31）。期间FU，酮（5.9％）患者在标准中
替诺福韦组比0的减少剂量组经历
一个乙肝病毒复发。该患者的乙肝病毒复发发生
后32.1个月是有关一个承认违规
服药。乙肝复发的任何预测因素可能
在单因素分析来识别。 HBeAg血清转换
发生在一个病人后减少剂量学组
24.7个月。开发了两个患者（每个组）
富时显著CKD 9.2和25.2个月后，分别。
没有预测因素的显著的发展
CKD可以在单因素分析来识别。然而，在
单因素和多因素分析，标准的替诺福韦用量
被确定为一个预测因子降低的GFR在端
傅（P = 0.038）。结论：这项研究表明，降低
而被替诺福韦剂量是一样有效标准剂量
成本较低并出现以赋予对肾有保护作用
功能。
披露：
伯纳德·E.·威廉姆斯 - 咨询委员会或审查小组：Gilead公司，顶点，
百灵达殷格翰公司，艾伯维，罗氏，扬森;格兰特/研究支持：基列，
顶点，百灵达-Ingelheim公司，默克，Cangene，艾伯维;口语和教学领域：
Gilead公司，扬森
让 - 皮埃尔·维伦纽夫 - 格兰特/研究支持：Gilead公司，转基因，Immune-
宪章
下面笔者都没有透露：艾琳乐Cleach，吉纳维夫
华德，克莱尔·福涅尔

作者: hchu 时间: 2015-10-5 16:46

是不是说：隔日一颗替诺，疗效相同而又不伤肾？

作者: StephenW 时间: 2015-10-5 17:05

hchu 发表于 2015-10-5 16:46
是不是说：隔日一颗替诺，疗效相同而又不伤肾？

是.
每日300mg v 每7天 3×300mg

慎重: 小样本, 病人资料没有描述.

作者: MP4 时间: 2015-10-5 17:09

hchu 发表于 2015-10-5 16:46
是不是说：隔日一颗替诺，疗效相同而又不伤肾？

半粒会比隔日好

作者: hchu 时间: 2015-10-5 17:46

MP4 发表于 2015-10-5 17:09
半粒会比隔日好

你这种说法有依据吗？请贴出相关研究文本，谢谢。

作者: MP4 时间: 2015-10-5 18:30

hchu 发表于 2015-10-5 17:46
你这种说法有依据吗？请贴出相关研究文本，谢谢。

半粒和隔日剂量一样，但是药效持续时间会长些，这药效常识吧

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