Background::Albuvirtide is a once-weekly injectable human immunodeficiency virus (HIV)-1 fusion inhibitor. We present interim data for a phase 3 trial assessing the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults already treated with antiretroviral drugs.Methods::We carried out a 48-week, randomized, controlled, open-label non-inferiority trial at 12 sites in China. Adults on the World Health Organization (WHO)-recommended first-line treatment for >6 months with a plasma viral load >1000 copies/mL were enrolled and randomly assigned (1:1) to receive albuvirtide (once weekly) plus ritonavir-boosted lopinavir (ABT group) or the WHO-recommended second-line treatment (NRTI group). The primary endpoint was the proportion of patients with a plasma viral load below 50 copies/mL at 48 weeks. Non-inferiority was prespecified with a margin of 12%.Results::At the time of analysis, week 24 data were available for 83 and 92 patients, and week 48 data were available for 46 and 50 patients in the albuvirtide and NRTI groups, respectively. At 48 weeks, 80.4% of patients in the ABT group and 66.0% of those in the NRTI group had HIV-1 RNA levels below 50 copies/mL, meeting the criteria for non-inferiority. For the per-protocol population, the superiority of albuvirtide over NRTI was demonstrated. The frequency of grade 3 to 4 adverse events was similar in the two groups; the most common adverse events were diarrhea, upper respiratory tract infections, and grade 3 to 4 increases in triglyceride concentration. Renal function was significantly more impaired at 12 weeks in the patients of the NRTI group who received tenofovir disoproxil fumarate than in those of the ABT group.Conclusions::The TALENT study is the first phase 3 trial of an injectable long-acting HIV drug. This interim analysis indicates that once-weekly albuvirtide in combination with ritonavir-boosted lopinavir is well tolerated and non-inferior to the WHO-recommended second-line regimen in patients with first-line treatment failure.Trial registration::ClinicalTrials.gov Identifier: NCT02369965; https://www.clinicaltrials.gov.

目的:探索艾博韦泰（albuvirtide，ABT）联合多替拉韦钠（dolutegravir，DTG）在住院初治艾滋病患者中的临床应用。方法:回顾性收集2019年7月至2020年12月期间在成都市公共卫生临床医疗中心感染一科住院且使用ABT联合DTG进行初始抗病毒治疗（ART）的106例艾滋病患者资料，探讨分析HIV病毒载量和CD4 +T细胞水平的变化及安全性。根据基线耐药检测结果将艾滋病患者分为耐药组和敏感组，分析治疗后HIV RNA和CD4 +T细胞的变化，并比较两组疗效差异。 结果:所有患者均合并严重机会性感染。基线HIV RNA为（5.42±0.07）lg拷贝/mL，75.47%（80/106）患者基线HIV RNA>10 5拷贝/mL；基线CD4 +T细胞为（62.92±8.22）个/μL，80.19%（85/106）患者基线CD4 +T细胞<100个/μL。ART治疗2周和4周后，HIV RNA较基线分别下降（2.75±0.07）lg拷贝/mL、（2.92±0.14）lg拷贝/mL（ χ 2= 1 466.40和436.24， P均<0.001），CD4较基线分别上升（49.18±14.28）个/μL、（94.03±20.19）个/μL（ χ 2= 11.86， P<0.001； χ 2= 21.69， P=0.001）。ART 4周，23.46%（19/81）的患者HIV RNA<40拷贝/mL。基线耐药检查发现22例患者存在非核苷类逆转录酶抑制剂（NNRTIs）或蛋白酶类抑制剂（PIs）药物耐药突变位点，以潜在耐药为主。ART 2周、4周，耐药组与敏感组患者HIV RNA和CD4水平差异均无统计学意义（HIV RNA: t=-0.29和0.63；CD4： t=-0.43和-1.42， P均>0.05）。部分患者基线存在肝功能、肾功能、血常规异常，治疗期间，无患者发生直接与ART药物相关的5级不良事件，无患者发生注射位点反应。 结论:住院初治艾滋病患者基线HIV复制活跃，免疫水平低下，ABT+DTG能快速降低HIV RNA，改善免疫功能，安全性良好。基线发现NNRTI或PI类药物耐药的患者，选择该用药方案同样有效。

目的 观察艾博韦泰(ABT)联合蛋白酶抑制剂(PIs)或整合酶抑制剂(INSTIs)的抗逆转录病毒治疗(ART)方案在HIV/AIDS合并肾功能损伤患者的疗效和安全性.方法 2021年3月-2023年3月期间,从郑州市第六人民医院感染科住院患者中筛选伴有肾功能损伤的HIV/AIDS初治或经治患者进入12周开放治疗.观察和比较基线及各治疗时间点HIV病毒载量(HIV RNA)、CD4+T淋巴细胞(CD4+T细胞)计数、肾功能等生化指标变化.结果 入组30例患者,26例完成12周治疗.26例患者基线情况:男性为主(88.46％),平均年龄(51.77±14.49)岁,初治患者占50％,69.23％和46.15％患者分别合并机会性感染和慢性合并症.急性肾损伤5例,慢性肾损伤21例,平均肾小球滤过率(eGFR)为38.30(14.94,69.57)mL/(min·1.73 m2),18例慢性肾损伤伴尿蛋白或尿微量白蛋白(ALB)阳性.4 例 HIV RNA≥105 CPs/mL,HIV RNA 在最低检测线(40 CPs/mL)～105 CPs/mL者12例;CD4+T细胞计数＜100个/μL 16例;ART治疗12周:初治、平稳转换、治疗失败患者病毒抑制率分别为76.92％(10/13)、100％(10/10)、100％(3/3).CD4+T 细胞计数从基线 75(28.75,203.75)个/μL 升至 156(90.25,359.25)个/μL,CD4+/CD8+比值从0.16(0.06,0.68)升至0.21(0.14,0.68),差异均有统计学意义(P＜0.05).12周eGFR、血清肌酐(Scr)、血红蛋白(Hb)较基线有好转,差异有统计学意义(P＜0.05);12周后25例患者转换为口服ART方案,其中17例完成12个月随访.12个月时:15例HIV RNA低于最低检测线,平均CD4+T细胞计数上升至212.00(102.50,333.00)个/μL,较12周时CD4+T细胞计数130.00(95.00,229.00)个/μL相比,差异有统计学意义(P＜0.05).结论 含有艾博韦泰ART方案治疗26例HIV/AIDS合并肾功能损伤患者取得良好的病毒抑制和免疫应答,同时具有良好的安全性,后续扩大样本值得进一步研究.