Failures of 1 week on, 1 week off antiretroviral therapies in a randomized trial
Failures of 1 week on, 1 week off antiretroviral therapies in a randomized trial
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随机试验中抗逆转录病毒治疗连续 1 周、停药 1 周失败
DOI：
10.1097/01.aids.0000088241.55968.65
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发表时间：
2003
期刊：
影响因子：
3.8
通讯作者：
B. Hirschel
中科院分区：
文献类型：
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作者：
J. Ananworanich;R. Nuesch;Michelle Le Braz;Ploechan Chetchotisakd;A. Vibhagool;Saijai Wicharuk;K. Ruxrungtham;H. Furrer;D. Cooper;B. Hirschel
背景资料：正在评估计划中断治疗的情况，以努力减少高效抗逆转录病毒疗法的费用和副作用。1周治疗和1周停药的时间表提供了减少50%药物暴露的承诺，同时持续检测不到HIV RNA浓度。研究方法：在Staccato研究中，600例成功接受HAART的患者被随机分配至继续治疗、CD 4指导治疗或治疗一周、停药一周。一个预定的初步分析评估的有效性在1-week-on-1-week off arm. Results：在36个可评估的患者，19（53%）有两个连续的HIV RNA浓度> 500拷贝/ml，在一周的治疗结束时，被归类为病毒学失败。大多数失败者服用去羟肌苷、司他夫定、沙奎那韦和利托那韦（11例）。在这些患者中，没有证据表明存在耐药性突变，血浆沙奎那韦水平在预期范围内。三个失败的三个患者中有两个有耐药突变，但仍然对重新引入三核苷酸治疗有反应。两名服用奈韦拉平的患者中的一名和八名服用依法韦仑的患者中的一名也失败了。两人在失败时都有耐药突变，但在基线时没有。结论：在Staccato研究中测试的1周给药1周停药方案显示出不可接受的高失败率，因此被终止。
Background: Scheduled treatment interruptions are being evaluated in an effort to decrease costs and side effects of highly active antiretroviral therapy (HAART). A schedule of 1 week on and 1 week off therapy offers the promise of 50% less drug exposure with continuously undetectable HIV RNA concentration. Methods: In the Staccato study 600 patients on successful HAART were to be randomized to either continued therapy, CD4-guided therapy, or one week on, one week off therapy. A scheduled preliminary analysis evaluated effectiveness in the 1-week-on–1-week-off arm. Results: Of 36 evaluable patients, 19 (53%) had two successive HIV RNA concentrations > 500 copies/ml at the end of the week off therapy, and were classified as virological failure. Most of those who failed took didanosine, stavudine, saquinavir, and ritonavir (11 patients). In these patients, there was no evidence of mutations suggestive of drug resistance, and plasma saquinavir levels were within the expected range. Two of three patients failing on triple nucleotides had drug resistance mutations, but nonetheless responded to reintroduction of triple nucleotide therapy. One of two patients taking nevirapine, and one of eight taking efavirenz, also failed. Both had resistance mutations at the time of failure, but not at baseline. Conclusions: The 1-week-on–1-week-off schedule, as tested in the Staccato study, showed an unacceptably high failure rate and was therefore terminated.
核苷逆转录酶抑制剂活性代谢物的细胞内研究：综述。
DOI：
--
发表时间：
2000
期刊：
Puerto Rico health sciences journal.
影响因子：
--
作者：
RodriguezOrengo,JF;Santana,J;Febo,I;Diaz,C;Rodriguez,JL;Garcia,R;Font,E;Rosario,O
通讯作者：
Rosario,O