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.
Identifieur interne : 002682 ( PubMed/Corpus ); précédent : 002681; suivant : 002683Brief 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.
Auteurs : Sharon Walmsley ; 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 PappaSource :
- Journal of acquired immune deficiency syndromes (1999) [ 1944-7884 ] ; 2015.
English descriptors
- KwdEn :
- Anti-HIV Agents (administration & dosage), Anti-HIV Agents (therapeutic use), Dideoxynucleosides (administration & dosage), Dideoxynucleosides (therapeutic use), Double-Blind Method, Drug Administration Schedule, Drug Combinations, Drug Therapy, Combination, HIV Infections (drug therapy), HIV-1, Heterocyclic Compounds, 3-Ring (administration & dosage), Heterocyclic Compounds, 3-Ring (therapeutic use), Humans, Lamivudine (administration & dosage), Lamivudine (therapeutic use).
- MESH :
- chemical , administration & dosage : Anti-HIV Agents, Dideoxynucleosides, Heterocyclic Compounds, 3-Ring, Lamivudine.
- chemical , therapeutic use : Anti-HIV Agents, Dideoxynucleosides, Heterocyclic Compounds, 3-Ring, Lamivudine.
- drug therapy : HIV Infections.
- Double-Blind Method, Drug Administration Schedule, Drug Combinations, Drug Therapy, Combination, HIV-1, Humans.
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.
DOI: 10.1097/QAI.0000000000000790
PubMed: 26262777
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‖‖GlaxoSmithKline, London, United Kingdom; and ¶¶GlaxoSmithKline, Research Triangle Park, NC.</nlm:affiliation></affiliation></author><author><name sortKey="Baumgarten, Axel" sort="Baumgarten, Axel" uniqKey="Baumgarten A" first="Axel" last="Baumgarten">Axel Baumgarten</name></author><author><name sortKey="Berenguer, Juan" sort="Berenguer, Juan" uniqKey="Berenguer J" first="Juan" last="Berenguer">Juan Berenguer</name></author><author><name sortKey="Felizarta, Franco" sort="Felizarta, Franco" uniqKey="Felizarta F" first="Franco" last="Felizarta">Franco Felizarta</name></author><author><name sortKey="Florence, Eric" sort="Florence, Eric" uniqKey="Florence E" first="Eric" last="Florence">Eric Florence</name></author><author><name sortKey="Khuong Josses, Marie Aude" sort="Khuong Josses, Marie Aude" uniqKey="Khuong Josses M" first="Marie-Aude" last="Khuong-Josses">Marie-Aude Khuong-Josses</name></author><author><name sortKey="Kilby, J Michael" sort="Kilby, J Michael" uniqKey="Kilby J" first="J Michael" last="Kilby">J Michael Kilby</name></author><author><name sortKey="Lutz, Thomas" sort="Lutz, Thomas" uniqKey="Lutz T" first="Thomas" last="Lutz">Thomas Lutz</name></author><author><name sortKey="Podzamczer, Daniel" sort="Podzamczer, Daniel" uniqKey="Podzamczer D" first="Daniel" last="Podzamczer">Daniel Podzamczer</name></author><author><name sortKey="Portilla, Joaquin" sort="Portilla, Joaquin" uniqKey="Portilla J" first="Joaquin" last="Portilla">Joaquin Portilla</name></author><author><name sortKey="Roth, Norman" sort="Roth, Norman" uniqKey="Roth N" first="Norman" last="Roth">Norman Roth</name></author><author><name sortKey="Wong, Deborah" sort="Wong, Deborah" uniqKey="Wong D" first="Deborah" last="Wong">Deborah Wong</name></author><author><name sortKey="Granier, Catherine" sort="Granier, Catherine" uniqKey="Granier C" first="Catherine" last="Granier">Catherine Granier</name></author><author><name sortKey="Wynne, Brian" sort="Wynne, Brian" uniqKey="Wynne B" first="Brian" last="Wynne">Brian Wynne</name></author><author><name sortKey="Pappa, Keith" sort="Pappa, Keith" uniqKey="Pappa K" first="Keith" last="Pappa">Keith Pappa</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:26262777</idno><idno type="pmid">26262777</idno><idno type="doi">10.1097/QAI.0000000000000790</idno><idno type="wicri:Area/PubMed/Corpus">002682</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002682</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">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.</title><author><name sortKey="Walmsley, Sharon" sort="Walmsley, Sharon" uniqKey="Walmsley S" first="Sharon" last="Walmsley">Sharon Walmsley</name><affiliation><nlm:affiliation>*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.</nlm:affiliation></affiliation></author><author><name sortKey="Baumgarten, Axel" sort="Baumgarten, Axel" uniqKey="Baumgarten A" first="Axel" last="Baumgarten">Axel Baumgarten</name></author><author><name sortKey="Berenguer, Juan" sort="Berenguer, Juan" uniqKey="Berenguer J" first="Juan" last="Berenguer">Juan Berenguer</name></author><author><name sortKey="Felizarta, Franco" sort="Felizarta, Franco" uniqKey="Felizarta F" first="Franco" last="Felizarta">Franco Felizarta</name></author><author><name sortKey="Florence, Eric" sort="Florence, Eric" uniqKey="Florence E" first="Eric" last="Florence">Eric Florence</name></author><author><name sortKey="Khuong Josses, Marie Aude" sort="Khuong Josses, Marie Aude" uniqKey="Khuong Josses M" first="Marie-Aude" last="Khuong-Josses">Marie-Aude Khuong-Josses</name></author><author><name sortKey="Kilby, J Michael" sort="Kilby, J Michael" uniqKey="Kilby J" first="J Michael" last="Kilby">J Michael Kilby</name></author><author><name sortKey="Lutz, Thomas" sort="Lutz, Thomas" uniqKey="Lutz T" first="Thomas" last="Lutz">Thomas Lutz</name></author><author><name sortKey="Podzamczer, Daniel" sort="Podzamczer, Daniel" uniqKey="Podzamczer D" first="Daniel" last="Podzamczer">Daniel Podzamczer</name></author><author><name sortKey="Portilla, Joaquin" sort="Portilla, Joaquin" uniqKey="Portilla J" first="Joaquin" last="Portilla">Joaquin Portilla</name></author><author><name sortKey="Roth, Norman" sort="Roth, Norman" uniqKey="Roth N" first="Norman" last="Roth">Norman Roth</name></author><author><name sortKey="Wong, Deborah" sort="Wong, Deborah" uniqKey="Wong D" first="Deborah" last="Wong">Deborah Wong</name></author><author><name sortKey="Granier, Catherine" sort="Granier, Catherine" uniqKey="Granier C" first="Catherine" last="Granier">Catherine Granier</name></author><author><name sortKey="Wynne, Brian" sort="Wynne, Brian" uniqKey="Wynne B" first="Brian" last="Wynne">Brian Wynne</name></author><author><name sortKey="Pappa, Keith" sort="Pappa, Keith" uniqKey="Pappa K" first="Keith" last="Pappa">Keith Pappa</name></author></analytic><series><title level="j">Journal of acquired immune deficiency syndromes (1999)</title><idno type="eISSN">1944-7884</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Anti-HIV Agents (administration & dosage)</term><term>Anti-HIV Agents (therapeutic use)</term><term>Dideoxynucleosides (administration & dosage)</term><term>Dideoxynucleosides (therapeutic use)</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Drug Combinations</term><term>Drug Therapy, Combination</term><term>HIV Infections (drug therapy)</term><term>HIV-1</term><term>Heterocyclic Compounds, 3-Ring (administration & dosage)</term><term>Heterocyclic Compounds, 3-Ring (therapeutic use)</term><term>Humans</term><term>Lamivudine (administration & dosage)</term><term>Lamivudine (therapeutic use)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Anti-HIV Agents</term><term>Dideoxynucleosides</term><term>Heterocyclic Compounds, 3-Ring</term><term>Lamivudine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-HIV Agents</term><term>Dideoxynucleosides</term><term>Heterocyclic Compounds, 3-Ring</term><term>Lamivudine</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>HIV Infections</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Drug Combinations</term><term>Drug Therapy, Combination</term><term>HIV-1</term><term>Humans</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26262777</PMID><DateCreated><Year>2015</Year><Month>11</Month><Day>14</Day></DateCreated><DateCompleted><Year>2016</Year><Month>02</Month><Day>19</Day></DateCompleted><DateRevised><Year>2016</Year><Month>12</Month><Day>15</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1944-7884</ISSN><JournalIssue CitedMedium="Internet"><Volume>70</Volume><Issue>5</Issue><PubDate><Year>2015</Year><Month>Dec</Month><Day>15</Day></PubDate></JournalIssue><Title>Journal of acquired immune deficiency syndromes (1999)</Title><ISOAbbreviation>J. Acquir. Immune Defic. Syndr.</ISOAbbreviation></Journal><ArticleTitle>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.</ArticleTitle><Pagination><MedlinePgn>515-9</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1097/QAI.0000000000000790</ELocationID><Abstract><AbstractText>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.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Walmsley</LastName><ForeName>Sharon</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>*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.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Baumgarten</LastName><ForeName>Axel</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Berenguer</LastName><ForeName>Juan</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Felizarta</LastName><ForeName>Franco</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Florence</LastName><ForeName>Eric</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Khuong-Josses</LastName><ForeName>Marie-Aude</ForeName><Initials>MA</Initials></Author><Author ValidYN="Y"><LastName>Kilby</LastName><ForeName>J Michael</ForeName><Initials>JM</Initials></Author><Author ValidYN="Y"><LastName>Lutz</LastName><ForeName>Thomas</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Podzamczer</LastName><ForeName>Daniel</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Portilla</LastName><ForeName>Joaquin</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Roth</LastName><ForeName>Norman</ForeName><Initials>N</Initials></Author><Author ValidYN="Y"><LastName>Wong</LastName><ForeName>Deborah</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Granier</LastName><ForeName>Catherine</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Wynne</LastName><ForeName>Brian</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Pappa</LastName><ForeName>Keith</ForeName><Initials>K</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01263015</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Acquir Immune Defic Syndr</MedlineTA><NlmUniqueID>100892005</NlmUniqueID><ISSNLinking>1525-4135</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D019380">Anti-HIV Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015224">Dideoxynucleosides</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004338">Drug Combinations</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D006575">Heterocyclic Compounds, 3-Ring</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C492871">abacavir, lamivudine drug combination</NameOfSubstance></Chemical><Chemical><RegistryNumber>2T8Q726O95</RegistryNumber><NameOfSubstance UI="D019259">Lamivudine</NameOfSubstance></Chemical><Chemical><RegistryNumber>DKO1W9H7M1</RegistryNumber><NameOfSubstance UI="C562325">dolutegravir</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CitationSubset>X</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2013 Nov 7;369(19):1807-18</RefSource><PMID Version="1">24195548</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2013 Mar 2;381(9868):735-43</RefSource><PMID Version="1">23306000</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>AIDS. 2013 Jul 17;27(11):1771-8</RefSource><PMID Version="1">23807273</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet Infect Dis. 2012 Feb;12(2):111-8</RefSource><PMID Version="1">22018760</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Infect Dis. 2013 Mar 1;207(5):740-8</RefSource><PMID Version="1">23225901</PMID></CommentsCorrections><CommentsCorrections RefType="ErratumIn"><RefSource>J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):e33</RefSource></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D019380" MajorTopicYN="N">Anti-HIV Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015224" MajorTopicYN="N">Dideoxynucleosides</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind 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MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019259" MajorTopicYN="N">Lamivudine</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC4645960</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>8</Month><Day>12</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>8</Month><Day>12</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>2</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26262777</ArticleId><ArticleId IdType="doi">10.1097/QAI.0000000000000790</ArticleId><ArticleId 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