简要报告：多替拉韦联合阿巴卡韦/拉米夫定用于初治HIV-1感染患者的抗逆转录病毒治疗：来自SINGLE随机临床试验的第96周和第144周结果
Brief Report: Dolutegravir Plus Abacavir/Lamivudine for the Treatment of HIV-1 Infection in Antiretroviral Therapy-Naive Patients: Week 96 and Week 144 Results From the SINGLE Randomized Clinical Trial.
作者信息
Walmsley Sharon, Baumgarten Axel, Berenguer Juan, Felizarta Franco, Florence Eric, Khuong-Josses Marie-Aude, Kilby J Michael, Lutz Thomas, Podzamczer Daniel, Portilla Joaquin, Roth Norman, Wong Deborah, Granier Catherine, Wynne Brian, Pappa Keith
机构信息
*University Health Network, Toronto, ON, Canada; †MIB Infectious Diseases Medical Center, Berlin, Germany; ‡Hospital General Universitario Gregorio Marañón, Madrid, Spain; §Private practice, Bakersfield, CA; ‖Institute of Tropical Medicine, Antwerp, Belgium; ¶Hôpital Delafontaine, Paris, France; #Medical University of South Carolina, Charleston, SC; **Infektiologikum Frankfurt, Frankfurt, Germany; ††Hospital Universitari de Bellvitge, L'Hospitalet, Barcelona, Spain; ‡‡Hospital General Universitario de Alicante, Alicante, Spain; §§Prahran Market Clinic, Melbourne, Australia; ‖‖GlaxoSmithKline, London, United Kingdom; and ¶¶GlaxoSmithKline, Research Triangle Park, NC.
出版信息
J Acquir Immune Defic Syndr. 2015 Dec 15;70(5):515-9. doi: 10.1097/QAI.0000000000000790.
The SINGLE study was a randomized, double-blind, noninferiority study that evaluated the safety and efficacy of 50 mg dolutegravir + abacavir/lamivudine versus efavirenz/tenofovir/emtricitabine in 833 ART-naive HIV-1 + participants. Of 833 randomized participants, 71% in the dolutegravir + abacavir/lamivudine arm and 63% in the efavirenz/tenofovir/emtricitabine arm maintained viral loads of <50 copies per milliliter through W144 (P = 0.01). Superior efficacy was primarily driven by fewer discontinuations due to adverse events in the dolutegravir + abacavir/lamivudine arm [dolutegravir + abacavir/lamivudine arm, 16 (4%); efavirenz/tenofovir/emtricitabine arm, 58 (14%)] through W144 [corrected]. No treatment-emergent integrase or nucleoside resistance was observed in dolutegravir + abacavir/lamivudine recipients through W144.
SINGLE研究是一项随机、双盲、非劣效性研究，评估了50毫克度鲁特韦+阿巴卡韦/拉米夫定与依非韦伦/替诺福韦/恩曲他滨在833名初治HIV-1阳性参与者中的安全性和疗效。在833名随机分组的参与者中，度鲁特韦+阿巴卡韦/拉米夫定组71%的参与者和依非韦伦/替诺福韦/恩曲他滨组63%的参与者在第144周时病毒载量维持在每毫升<50拷贝（P = 0.01）。度鲁特韦+阿巴卡韦/拉米夫定组疗效更优主要是由于该组因不良事件导致停药的情况较少[度鲁特韦+阿巴卡韦/拉米夫定组，16例（4%）；依非韦伦/替诺福韦/恩曲他滨组，58例（14%）]，至第144周时[校正后]。在度鲁特韦+阿巴卡韦/拉米夫定治疗的参与者中，至第144周时未观察到新出现的整合酶或核苷类耐药。
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