University Medical Center Groningen, Dept. of Internal Medicine, Groningen, The Netherlands.
AIDS Patient Care STDS. 2010 Jun;24(6):361-6. doi: 10.1089/apc.2009.0236.
Maintenance with a triple nucleoside reverse transcriptase Inhibitor (NRTI) regimen after successful induction with a dual NRTI/protease inhibitor (PI) combination may be advantageous, because of low pill burden, favorable lipids, and less drug interactions. This strategy to become free of PI-related problems without losing viral efficacy has not been formally tested. We performed a randomized, open-label, multicenter, 96-week comparative study in antiretroviral therapy (ART)-naïve patients with CD4 <or=350 cells/mm(3) and HIV-1 RNA concentrations (viral load [VL]) greater than 30,000 copies per milliliter. Patients were randomized after reaching VL less than 50 copies per milliliter on two consecutive occasions between 12 and 24 weeks after start of zidovudine/lamuvidine and lopinavir/ritonavir combination. Eligible subjects switched to abacavir/lamivudine/zidovudine (TZV) or continued the PI-containing regimen. Here we present the 48-week data with virologic success rate (failure: VL > 50 copies per milliliter). Two hundred seven patients had similar baseline (BL) characteristics: median CD4 180 cells/mm(3), median VL 5.19 log(10) copies per milliliter. One hundred twenty subjects (58%) met randomization criteria. Baseline VL differed significantly between dropouts and randomized subjects (median 5.41 versus 5.06 log(10) copies per milliliter, p = 0.017), as did CD4 cells (median 160 and 200 cells/mm(3), p = 0.044). Sixty-one subjects received TZV and 59 subjects continued NRTIs/PI. At week 48, 2 patients in the TZV group and 5 in the PI group did not have a sustained virologic suppression (log rank test; p = 0.379). CD4 counts increased significantly in both arms. In ART-naïve patients, TZV maintenance had similar antiviral efficacy compared to continued standard ART at 48 weeks after baseline. Patients on successful standard ART can be safely switched to a NRTI-only regimen, at least for the tested time period.
在成功诱导双重核苷反转录酶抑制剂（NRTI）/蛋白酶抑制剂（PI）联合治疗后，采用三联 NRTI 方案进行维持治疗可能具有优势，因为这种方案的药物剂量小、对脂类影响小、药物相互作用少。这种避免与 PI 相关问题而不降低病毒疗效的策略尚未经过正式检验。我们在未接受过抗逆转录病毒治疗（ART）的患者中进行了一项随机、开放标签、多中心、96 周的比较研究，这些患者的 CD4<350 个细胞/mm3，HIV-1 RNA 浓度（病毒载量[VL]）大于 30000 拷贝/ml。在开始使用齐多夫定/拉米夫定和洛匹那韦/利托那韦联合治疗后 12 至 24 周内，两次连续达到 VL 小于 50 拷贝/ml 后，患者被随机分配。符合条件的受试者转换为阿巴卡韦/拉米夫定/齐多夫定（TZV）或继续使用含 PI 的方案。在此，我们介绍了病毒学应答率（失败：VL>50 拷贝/ml）的 48 周数据。207 名患者具有相似的基线（BL）特征：中位 CD4 为 180 个细胞/mm3，中位 VL 为 5.19 log10拷贝/ml。120 名患者（58%）符合随机分组标准。脱落者和随机分组者的基线 VL 差异显著（中位数 5.41 与 5.06 log10拷贝/ml，p=0.017），CD4 细胞也存在显著差异（中位数 160 与 200 个细胞/mm3，p=0.044）。61 名患者接受了 TZV，59 名患者继续使用 NRTI/PI。在第 48 周时，TZV 组有 2 名患者和 PI 组有 5 名患者未获得持续病毒学抑制（对数秩检验；p=0.379）。两组的 CD4 计数均显著增加。在基线后 48 周时，与继续使用标准 ART 相比，TZV 维持治疗在接受初次 ART 的患者中具有相似的抗病毒疗效。至少在测试期间，成功接受标准 ART 的患者可以安全地转换为仅使用 NRTI 的方案。
