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【文摘发布】 Saquinavir, Ritonavir,及 Atazanavir单独或
Author: Alan Winston,1,2 Patrick W. G. Mallon,1,2 Claudette Satchell,1 Karen MacRae,2 Kenneth M. Williams,2 Malte Schutz,3 Matthew Law,1 David A. Cooper,1,2 and Sean Emery
Resourse: Clinical Infectious Diseases 2007;44:1475-1483
Background. Toxicities observed with current combination antiretroviral therapy (CART) warrant a search for novel options, such as class-sparing regimens. Ritonavir-boosted double–protease inhibitor (PI)–only regimens are such an option but are prone to pharmacokinetic interactions.
Methods. This 48-week randomized study examined the safety and efficacy of a switch in CART to a once-daily regimen of saquinavir (SQV), ritonavir (RTV), and atazanavir (ATV) that did not include nucleoside reverse-transcriptase inhibitors (NRTIs). The study also assessed the pharmacokinetic profile of a change in the SQV formulation, from 200 mg to 500 mg, in 2 regimens (SQV-RTV twice per day plus NRTIs [arm 1] and SQV-RTV-ATV once per day without NRTIs [arm 2]) in human immunodeficiency virus type 1–infected subjects (plasma human immunodeficiency virus RNA level, <50 copies/mL). Patients underwent an initial SQV formulation change or a CART change to SQV-RTV-ATV with intense pharmacokinetic sampling. All patients were subsequently assigned to receive SQV-RTV-ATV (1500, 100, and 300 mg once per day, respectively) without NRTIs for 48 weeks. The primary end point was the percentage of patients who experienced virologic failure.
Results. Of 25 subjects enrolled, scleral icterus was the most common adverse event (3 patients [12.5%]). Three subjects (12.5%) experienced virologic failure; and mean (± standard error of the mean) increase in the CD4+ lymphocyte count was 63 ± 36 cells/L over 48 weeks (P = .012). The SQV geometric mean area under the time curve parameters were not significantly altered for the 2 SQV formulations (arm 1, 23.32 vs. 18.76 ng × h/mL [geometric mean ratio, 0.80] for the 200-mg vs. 500-mg formulations, respectively; arm 2, 50.31 vs. 44.79 ng × h/mL [geometric mean ratio, 0.88], for the 200-mg vs. 500-mg formulations, respectively).
Conclusions. A CART regimen of SQV-RTV-ATV alone demonstrated sustained virologic efficacy and was associated with significant increases in the CD4+ lymphocyte count. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Title: The Safety, Efficacy, and Pharmacokinetic Profile of a Switch in Antiretroviral Therapy to Saquinavir, Ritonavir, and Atazanavir Alone for 48 Weeks and a Switch in the Saquinavir Formulation
标题：抗逆转录病毒疗法转为沙奎那韦、利托那韦和阿他那韦单独治疗48周及沙奎那韦配方设计改变的安全性、有效性和药代动力学特征
Author: Alan Winston,1,2 Patrick W. G. Mallon,1,2 Claudette Satchell,1 Karen MacRae,2 Kenneth M. Williams,2 Malte Schutz,3 Matthew Law,1 David A. Cooper,1,2 and Sean Emery
作者：Alan Winston等
Resourse: Clinical Infectious Diseases 2007;44:1475-1483
来源：《Clinical Infectious Diseases》。2007年44卷，1475-1483页
Background. Toxicities observed with current combination antiretroviral therapy (CART) warrant a search for novel options, such as class-sparing regimens.
背景：当前联合抗逆转录病毒疗法（CART）中观察到的毒性作用促使人们寻求新的选择，例如药物缩减疗法。
Ritonavir-boosted double–protease inhibitor (PI)–only regimens are such an option but are prone to pharmacokinetic interactions.
单独的利托那韦用量增加的双蛋白酶抑制剂（PI）疗法正是其中之一，但在药代动力学上两者易于产生相互作用。
Methods. This 48-week randomized study examined the safety and efficacy of a switch in CART to a once-daily regimen of saquinavir (SQV), ritonavir (RTV), and atazanavir (ATV) that did not include nucleoside reverse-transcriptase inhibitors (NRTIs).
方法：这项为期48周的随机研究分析了由CART转为沙奎那韦（SQV）、利托那韦（RTV）和阿他那韦(ATV) 之每日一次疗法的安全性和有效性，而该疗法并不包括核苷逆转录酶抑制剂（NRTIs）。
The study also assessed the pharmacokinetic profile of a change in the SQV formulation, from 200 mg to 500 mg, in 2 regimens (SQV-RTV twice per day plus NRTIs [arm 1] and SQV-RTV-ATV once per day without NRTIs [arm 2]) in human immunodeficiency virus type 1–infected subjects (plasma human immunodeficiency virus RNA level, <50 copies/mL).
该研究也评估了SQV配方设计改变，即2种疗法（组1，SQV-RTV每天2并合用NRTIs；组2，SQV-RTV-ATV每天1次，不用NRTIs）中剂量从200mg至500mg，在HIV-1感染受试者（血浆HIV RNA水平小于50拷贝/毫升）的药代动力学特征。
Patients underwent an initial SQV formulation change or a CART change to SQV-RTV-ATV with intense pharmacokinetic sampling.
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作者:admin@医学,生命科学 2011-05-02 17:11
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