Lamarca Anthony, Clumeck Nathan, Plettenberg Andreas, Domingo Pere, Fu Kaisong, Craig Charles, Zhao Henry, Watson Maria, Gordon David, Scott Trevor
Therafirst Medical, Fort Lauderdale, FL, USA.
J Acquir Immune Defic Syndr. 2006 Apr 15;41(5):598-606. doi: 10.1097/01.qai.0000214821.33905.5c.
A one-tablet, once-daily abacavir/lamivudine fixed-dose combination (FDC) has been recently approved to treat HIV-1 infection.
A randomized, open-label, parallel-group, multicenter study to compare the efficacy and safety of the FDC group to the separate entities (SE) group, in combination with tenofovir and a new protease inhibitor or nonnucleoside reverse transcription inhibitor in antiretroviral-experienced adults experiencing virologic failure (VF). Eligible subjects had viral loads >1000 copies/mL with < or =3 nucleoside reverse transcription inhibitor-associated mutations. The primary efficacy end point was time-average changed from baseline (average area under the curve minus baseline) in plasma HIV-1 RNA over 48 weeks.
A total of 186 subjects were enrolled. The average area under the curve minus baseline was -1.65 and -1.83 log10 copies/mL in the FDC and SE groups, respectively (intention to treat; 95% confidence interval: -0.13, 0.38). Patients in the FDC (50%) and SE groups (47%) achieved viral loads <50 copies/mL based on the time to loss of virologic response algorithm. VF was low and similar in both groups (FDC, 16%; SE, 18%). Tolerability was similar between the 2 groups.
The FDC group had noninferior efficacy over 48 weeks to the SE group in treatment-experienced subjects with VF.
一种每日一次的阿巴卡韦/拉米夫定单片固定剂量组合（FDC）最近已被批准用于治疗HIV-1感染。
一项随机、开放标签、平行组、多中心研究，旨在比较FDC组与单独用药组（SE）在联合替诺福韦和一种新型蛋白酶抑制剂或非核苷类逆转录酶抑制剂治疗中，对有抗逆转录病毒治疗史且出现病毒学失败（VF）的成年人的疗效和安全性。符合条件的受试者病毒载量>1000拷贝/mL，且有≤3个与核苷类逆转录酶抑制剂相关的突变。主要疗效终点是48周内血浆HIV-1 RNA相对于基线的时间平均变化（曲线下面积平均值减去基线）。
共纳入186名受试者。FDC组和SE组曲线下面积平均值减去基线分别为-1.65和-1.83 log10拷贝/mL（意向性分析；95%置信区间：-0.13，0.38）。根据病毒学应答丧失时间算法，FDC组（50%）和SE组（47%）的患者病毒载量<50拷贝/mL。两组的VF发生率均较低且相似（FDC组为16%；SE组为18%）。两组的耐受性相似。
在有VF的有治疗史受试者中，FDC组在48周的疗效不劣于SE组。
