Hospital Universitario Doce de Octubre, imas12, UCM, Madrid.
Hospital Universitari Vall d'Hebron, Barcelona.
Clin Infect Dis. 2017 Nov 29;65(12):2112-2118. doi: 10.1093/cid/cix734.
Our objective was to assess the therapeutic noninferiority of dual therapy with darunavir/ritonavir and lamivudine compared to triple therapy with darunavir/ritonavir plus 2 nucleos(t)ides for maintenance of human immunodeficiency virus type 1 (HIV-1) suppression.
This was a multicenter, open-label, noninferiority trial (margin 12%). Patients with HIV-1 RNA <50 copies/mL for 6 months or longer on triple therapy with darunavir/ritonavir and 2 nucleos(t)ides (tenofovir disoproxil fumarate and emtricitabine or abacavir and lamivudine) and with no resistance were randomized to continue therapy (n = 128) or switch to darunavir/ritonavir and lamivudine (n = 129). The primary endpoint was the proportion of participants with HIV-RNA <50 copies/mL after 48 weeks of follow-up according to the snapshot algorithm.
A total of 249 participants received study drugs (intention-to-treat exposed). The proportion of participants with HIV-RNA <50 copies/mL in the dual- and triple-therapy arms was 88.9% (112/126) and 92.7% (114/123; difference, -3.8%; 95% confidence interval, -11.0 to 3.4), respectively. Four participants in the dual-therapy arm and 2 in the triple-therapy arm developed protocol-defined virological failure. Switching to dual therapy was associated with a significant increase in total, low-density lipoprotein, and high-density lipoprotein (HDL) cholesterol, but not in the total-to-HDL cholesterol ratio. Serious adverse events and study drug discontinuations due to adverse events occurred in 4.8% vs 4.9%P = .97) and in 0.8% (1/126) vs 1.6% P = .55) in dual therapy vs triple therapy, respectively.
Dual therapy with darunavir/ritonavir and lamivudine demonstrated noninferior therapeutic efficacy and similar tolerability compared to triple therapy.
NCT02159599.
我们的目的是评估达芦那韦/利托那韦与拉米夫定双联治疗与达芦那韦/利托那韦加两种核苷（酸）类药物三联治疗维持人类免疫缺陷病毒 1 型（HIV-1）抑制的非劣效性。
这是一项多中心、开放性、非劣效性试验（边界值 12%）。128 名 HIV-1 RNA 在接受达芦那韦/利托那韦和两种核苷（酸）类药物（富马酸替诺福韦二吡呋酯和恩曲他滨或阿巴卡韦和拉米夫定）三联治疗 6 个月或更长时间且病毒载量<50 拷贝/ml、无耐药的患者，随机继续接受治疗（n=128）或换用达芦那韦/利托那韦和拉米夫定（n=129）。主要终点是根据快照算法，48 周随访后 HIV-RNA<50 拷贝/ml 的参与者比例。
共有 249 名参与者接受了研究药物（意向治疗暴露）。双药和三联治疗组中 HIV-RNA<50 拷贝/ml 的参与者比例分别为 88.9%（112/126）和 92.7%（114/123；差异-3.8%；95%置信区间-11.0 至 3.4）。双药治疗组有 4 名患者和三联治疗组有 2 名患者发生了方案定义的病毒学失败。换用双联治疗与总胆固醇、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇（HDL-C）显著升高有关，但与总胆固醇/高密度脂蛋白胆固醇比值无关。严重不良事件和因不良事件导致的药物停药在双药组和三联组中分别为 4.8%（1/126）和 4.9%（1/123）（P=0.97）和 0.8%（1/126）和 1.6%（P=0.55）。
与三联治疗相比，达芦那韦/利托那韦联合拉米夫定的双联治疗具有非劣效的疗效和相似的耐受性。
NCT02159599。
