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目的:比较多拉韦林（doravirine，DOR）或达芦那韦/利托那韦（darunavir/ritonavir，DRV/r）联合两种核苷反转录酶抑制剂用于既往没有接受过任何治疗的HIV-1成年感染者的临床疗效。方法:此项随机、对照、双盲、多中心、非劣效性试验纳入HIV-1感染成年人按1：1方式随机分配至DOR（100 mg，每日一次口服）组或DRV（100 mg）/r（800 mg，每日一次口服）联合组，各组再分别接受由研究人员选定的两种核苷反转录酶抑制剂（nucleoside reverse transcriptase inhibitors，NRTIs）替诺福韦与恩曲他滨或阿巴卡韦与拉米夫定，直至96周。主要疗效终点是在第48周时达到血浆HIV-1 RNA小于50 copies/mL的受试者比例，如果治疗差异（DOR组减去DRV/r组）的双侧95%可信区间下限大于-10%可确定其具有非劣效性。结果:769例入选者被随机分配接受治疗，其中385例接受DOR治疗，384例接受DRV/r治疗。在第48周时，321例（83.8%）DOR组受试者和306例（79.9%）DRV/r组受试者血浆HIV-1 RNA低于50 copies/mL（差异为3.9%，95%n CI：1.6~9.4），证明了DOR给药方案的非劣效性。研究中最常见的药物相关不良反应为腹泻（DOR组21例（5.5%），DRV/r组49例（12.8%））、恶心（分别为25例（6.5%）和29例（7.6%）））以及头痛（分别为23例（6.0%）和10例（2.6%））。18例研究受试者包括DOR组的6例（1.6%）和DRV/r组的12例感染者（3.0%）因不良反应而终止治疗。各组有1例（0.3%）受试者的严重不良反应与研究药物相关。n 结论:DOR联合两种NRTI的治疗方案为初次接受治疗的成年HIV-1感染者提供了一种有价值的治疗选择。“,”Objective:To compared the clinical efficacy of doravirine (DOR) and darunavir/ritonavir (DRV/r), both combined with two nucleoside reverse transcriptase inhibitors (NRTIs), for adults with previously untreated HIV-1 infection.Methods:In this randomised, controlled, double-blind, multicentre, non-inferiority trial, adults with HIV-1 infection were enrolled and randomly assigned (1:1) to DOR group (100 mg, once daily) or DRV/r (800 mg/100 mg, once daily) group. Each group received two investigator-selected NRTIs (tenofovir and emtricitabine or abacavir and lamivudine) for up to 96 weeks. The primary efficacy endpoint was the proportion of participants achieving HIV-1 RNA of less than 50 copies per mL at week 48. The non-inferiority was established if the lower bound of the two-sided 95%CI for the treatment difference (DOR group minus DRV/r group) was greater than -10 percentage points.Results:A total of 769 participants were randomly assigned to treatment, including 385 with DOR and 384 with DRV/r. At week 48, 321 (83.8%) participants in the DOR group and 306 (79.9%) in the DRV/r group achieved plasma HIV-1 RNA of less than 50 copies per mL (difference: 3.9%, 95%n CI: 1.6 - 9.4), indicating non-inferiority of the DOR regimen. The most common drug-related adverse events were diarrhoea (21 in DOR group, 5.5%; 49 in DRV/r group, 12.8%, respectively), nausea (25, 6.5% vs 29, 7.6%), and headache (23, 6.0% vs 10, 2.6%). Eighteen participants (6 in DOR group, 1.6%; 12 in DRV/r group, 3.0%, respectively) discontinued treatment due to adverse events. Serious adverse events which were considered study-drug related occurred in one (0.3%) participant of each group.n Conclusions:In treatment-naive adults with HIV-1 infection, DOR combined with two NRTIs might offer a valuable treatment option for adults with previously untreated HIV-1 infection.