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Randomized Controlled Trial
. 2015 Dec 15;70(5):515-9.
doi: 10.1097/QAI.0000000000000790.

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

Sharon Walmsley  1 , Axel Baumgarten, Juan Berenguer, Franco Felizarta, Eric Florence, Marie-Aude Khuong-Josses, J Michael Kilby, Thomas Lutz, Daniel Podzamczer, Joaquin Portilla, Norman Roth, Deborah Wong, Catherine Granier, Brian Wynne, Keith Pappa
Affiliations
Randomized Controlled Trial

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

Sharon Walmsley et al. J Acquir Immune Defic Syndr. .

Erratum in

  • J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):e33

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01263015.

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Conflict of interest statement

Supported by ViiV Healthcare. ViiV Healthcare contracted GlaxoSmithKline to conduct the clinical trials of the compound. D.W. is an employee of GlaxoSmithKline. A.B. is currently a board member for AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Janssen-Cilag, MSD, and Roche; has received grant funding from ViiV Healthcare; and has received payment for lectures, including service on speaker bureaus, from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Janssen-Cilag, MSD, Roche, and ViiV Healthcare. J.B. has received grant funding from Bristol-Myers Squibb, Gilead, and ViiV Healthcare and has received consultancy fees and payment for lectures, including service on speaker bureaus, from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, MSD, and ViiV Healthcare. F.F. has received payment for lectures, including service on speaker bureaus, from AbbVie, Gilead, Janssen, Merck, and ViiV Healthcare. E.F. has received grant funding from ViiV Healthcare and has received payment for serving on an advisory board for ViiV Healthcare. M.A.K.J. has received payment for providing expert testimony from MSD and for travel/accommodations/meeting expenses unrelated to activities listed from Tibotec. M.K. has received grant funding and support for travel to meetings for the study or other purposes from GlaxoSmithKline/ViiV Healthcare. T.L. has received grant funding from AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Gilead, Janssen, MSD, Roche, and ViiV Healthcare; has received support for travel to meetings for the study or other purposes from GlaxoSmithKline; has received payment for serving on advisory boards for and received consultancy fees from AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Gilead, Janssen, MSD, and ViiV Healthcare; has received payment for lectures, including service on speaker bureaus, from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, MSD, and ViiV Healthcare; and has received payment for travel/accommodations/meeting expenses unrelated to activities listed from AbbVie, Gilead, and ViiV Healthcare. D.P. has received consultancy fees, grant funding, and payment for lectures, including service on speaker bureaus, from Abbott, Bristol-Myers Squibb, Gilead, Janssen, Merck, Pfizer, and ViiV Healthcare, and has received travel/accommodations/meeting expenses unrelated to activities listed from Boehringer Ingelheim. J.P. has received grant funding from Gilead, Janssen-Cilag, and ViiV Healthcare; has received payment for lectures, including service on speaker bureaus, from AbbVie, Bristol-Myers Squibb, Gilead, Janssen-Cilag, MSD, and ViiV Healthcare; has received payment for development of educational presentations from AbbVie, Gilead, and ViiV Healthcare; and has received payment for travel/accommodations/meeting expenses unrelated to activities listed from Gilead and Janssen-Cilag. N.R. has received consultancy fees from ViiV Healthcare. S.W. has received grant funding and support for travel to meetings for the study or other purposes from GlaxoSmithKline/ViiV Healthcare and has received consultancy fees, grant funding, and payment for lectures, including service on speaker bureaus, from Abbott, Gilead, Janssen, Merck, and ViiV Healthcare. C.G., B.W., and K.P. are employees of and may hold stock options in GlaxoSmithKline.

Figures

FIGURE 1
FIGURE 1
Proportion <50 copies per milliliter (95% CI) and CD4 change from baseline. BL, baseline; DTG + ABC/3 TC, dolutegravir + abacavir/lamivudine; EFV/TDF/FTC, efavirenz/tenofovir disoproxil fumarate/emtricitabine; QD, once daily; SE, standard error.
See this image and copyright information in PMC

References

    1. Walmsley SL, Antela A, Clumeck N, et al. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013;369:1807–1818. - PubMed
    1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines For the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Department of Health and Human Services; Available at: http://aidsinfo.nih.gov/contentfiles/lvguidelines/AdultandAdolescentGL.pdf. Accessed May 1, 2014.
    1. Eron JJ, Clotet B, Durant J, et al. Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-week results of the VIKING study. J Infect Dis. 2013;207:740–748. - PMC - PubMed
    1. Raffi F, Rachlis A, Stellbrink HJ, et al. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013;381:735–743. - PubMed
    1. Stellbrink HJ, Reynes J, Lazzarin A, et al. Dolutegravir in antiretroviral-naive adults with HIV-1: 96-week results from a randomized dose-ranging study. AIDS. 2013;27:1771–1778. - PMC - PubMed

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