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一项关于新型每日一次抗逆转录病毒药物的单中心队列研究经验。

A single centre cohort experience with a new once daily antiretroviral drug.

作者信息

Stebbing J, Bower M, Holmes P, Gazzard B, Nelson M

机构信息

Department of HIV Medicine, Chelsea and Westminster Hospital, London, UK.

出版信息

Postgrad Med J. 2006 May;82(967):343-6. doi: 10.1136/pgmj.2006.044867.

DOI:10.1136/pgmj.2006.044867
PMID:16679474
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2563794/
Abstract

BACKGROUND

Atazanavir, an azadipeptide protease inhibitor (PI) with once daily dosing, a lack of insulin resistance, lipid increase, and gastrointestinal toxicities, is approved in combination with other antiretrovirals for the treatment of patients infected with HIV. Unboosted atazanavir is also used in highly active antiretroviral therapy (HAART) naive patients.

METHODS

The study prospectively followed up an established cohort of patients who received atazanavir, and for whom one year of follow up data were available.

RESULTS

It was found that use of atazanavir in intent to treat and on treatment analyses, maintained and led to virological suppression and increases in CD4 count in both PI naive and experienced patients. Virological failure occurred in 7% of patients and the main toxicity was hyperbilirubinaemia, which led to treatment withdrawal in 2%. Its efficacy and safety profile was similar to that seen in previous randomised studies investigating its use.

CONCLUSIONS

These data should provide reassurance for clinicians wishing to introduce a new antiretroviral into an established cohort.

摘要

背景

阿扎那韦是一种氮杂二肽蛋白酶抑制剂(PI),每日服用一次,不存在胰岛素抵抗、脂质增加和胃肠道毒性等问题,已被批准与其他抗逆转录病毒药物联合用于治疗感染HIV的患者。未联用增效剂的阿扎那韦也用于初治的高效抗逆转录病毒治疗(HAART)患者。

方法

该研究对一组接受阿扎那韦治疗且有一年随访数据的既定队列患者进行了前瞻性随访。

结果

发现在意向性治疗分析和实际治疗分析中,使用阿扎那韦能使初治和经治患者维持并实现病毒学抑制,且CD4细胞计数增加。7%的患者出现病毒学失败,主要毒性为高胆红素血症,2%的患者因该毒性而停药。其疗效和安全性与之前研究其应用的随机试验结果相似。

结论

这些数据应为希望在既定队列中引入新抗逆转录病毒药物的临床医生提供信心。

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Clin Infect Dis. 2006 Jan 15;42(2):291-5. doi: 10.1086/499056. Epub 2005 Dec 8.
2
Clinical validation of atazanavir/ritonavir genotypic resistance score in protease inhibitor-experienced patients.阿扎那韦/利托那韦基因型耐药评分在曾使用蛋白酶抑制剂患者中的临床验证
AIDS. 2006 Jan 2;20(1):35-40. doi: 10.1097/01.aids.0000196179.11293.fc.
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Comparison of atazanavir with lopinavir/ritonavir in patients with prior protease inhibitor failure: a randomized multinational trial.阿扎那韦与洛匹那韦/利托那韦用于既往蛋白酶抑制剂治疗失败患者的比较:一项随机多国试验。
Curr Med Res Opin. 2005 Oct;21(10):1683-92. doi: 10.1185/030079905x65439.
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Use of bilirubin as a marker of adherence to atazanavir-based antiretroviral therapy.使用胆红素作为基于阿扎那韦的抗逆转录病毒疗法依从性的标志物。
AIDS. 2005 Oct 14;19(15):1700-2. doi: 10.1097/01.aids.0000186826.60983.85.
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