A lopinavir/ritonavir-based once-daily regimen results in better compliance and is non-inferior to a twice-daily regimen through 96 weeks
A lopinavir/ritonavir-based once-daily regimen results in better compliance and is non-inferior to a twice-daily regimen through 96 weeks
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DOI：
10.1089/aid.2007.0107
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发表时间：
2007-12-01
影响因子：
1.5
通讯作者：
Hanna, George J.
中科院分区：
文献类型：
--
作者：
Molina, Jean-Michel;Podsadecki, Thomas J.;Hanna, George J.
在96周的治疗中，我们评估了安全性和有效性，并评估了洛比那韦/利托那韦(LPV/r)剂量Qd或Bid在抗逆转录病毒初治的HIV-1感染者中的依从性。进行了一项随机、开放标签的多中心对照研究。共有190名抗逆转录病毒初治者入选，血浆HIV-1RNA>1000拷贝/毫升，且有任何CD4(+)T细胞计数。受试者被随机分为LPV/R800/200 mg qd(n=115)和400/100 mg bid(n=75)。受试者接受TDF300 mg和FTC 200 mg，qd。使用MEMS(R)监视器测量在96周内对LPV/r的依从性。基线VL和CD4(+)T细胞计数的中位数分别为4.8log(10)拷贝/ml和216个/mm(3)。在96周之前，37%(QD)和39%(BID)的受试者停止治疗，主要原因是不良事件(17%QD，9%BID)或失去随访或未坚持(12%QD，17%BID)。VL<；50拷贝/毫升的受试者比例[57%qd，53%Bid；p=0.582(ITT NC=F)]，CD_4计数的变化(244cell/mm(3)qd，264 cell/mm(3)id；p=0.513)，以及在96周内不同组之间的耐药性演变没有差异。腹泻(17%qd，5%bid，p=0.014)是最常见的中、重度药物相关不良事件。QD组对LPV/r的依从性高于BID组，随着时间的推移，两组患者的LPV/r均有所下降。在两组中，病毒应答消失的时间与坚持LPV/r显著相关。在抗逆转录病毒初治的受试者中，LPV/r qd在96周内产生了与LPV/r bid相似的病毒学应答。QD组依从性显著高于QD组。
We assessed the safety and efficacy and evaluated the adherence to lopinavir/ritonavir (LPV/r) dosed QD or BID in antiretroviral-naive, HIV-1-infected subjects through 96 weeks of treatment. A randomized, open-label, multicenter comparative study was conducted. A total of 190 antiretroviral-naive subjects with plasma HIV-1 RNA above 1000 copies/ml and any CD4(+) T cell count were enrolled. Subjects were randomized (3:2) to LPV/r 800/200 mg QD (n = 115) or 400/100 mg BID (n = 75). Subjects received TDF 300 mg and FTC 200 mg QD. Adherence to LPV/r through 96 weeks was measured using MEMS (R) monitors. Median baseline VL and CD4(+) T cell count were 4.8 log(10) copies/ml and 216 cells/mm(3), respectively. Prior to week 96, 37% (QD) and 39% (BID) of subjects discontinued, primarily due either to adverse events (17% QD, 9% BID) or to loss to follow-up or nonadherence (12% QD, 17% BID). The proportion of subjects with VL < 50 copies/ml [57% QD, 53% BID; p = 0.582 (ITT NC = F)], change in CD4 count (244 cells/mm(3) QD, 264 cells/mm(3) BID; p = 0.513), and evolution of resistance did not differ between groups through 96 weeks. Diarrhea (17% QD, 5% BID, p = 0.014) was the most common moderate or severe, study drug-related adverse event. Adherence to LPV/r was higher for the QD group than the BID group and declined over time in both groups. Time to loss of virologic response was significantly associated with adherence to LPV/r in both groups. LPV/r QD resulted in virologic response similar to LPV/r BID through 96 weeks in antiretroviral-naive subjects. Adherence was significantly higher in the QD group.