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.
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.
*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.
Sharon
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Walmsley
Axel
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Juan
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Berenguer
Franco
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Felizarta
Eric
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Florence
Marie-Aude
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Khuong-Josses
J Michael
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Kilby
Thomas
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Lutz
Daniel
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Podzamczer
Joaquin
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Portilla
Norman
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Roth
Deborah
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Wong
Catherine
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Granier
Brian
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Keith
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D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use; D015224:Dideoxynucleosides / Q000008:administration & dosage* / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1; D006575:Heterocyclic Compounds, 3-Ring / Q000008:administration & dosage* / Q000627:therapeutic use*; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage* / Q000627:therapeutic use*; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D000099226:Dolutegravir; D000099227:Abacavir
D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D004338:Drug Combinations; D006575:Heterocyclic Compounds, 3-Ring; D019259:Lamivudine; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D000099226:Dolutegravir; C492871:abacavir, lamivudine drug combination; D000099227:Abacavir