Safety and Efficacy of Dolutegravir in Treatment-Experienced Subjects With Raltegravir-Resistant HIV Type 1 Infection: 24-Week Results of the VIKING Study

Background. Dolutegravir (DTG; S/GSK1349572), a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, has limited cross-resistance to raltegravir (RAL) and elvitegravir in vitro. This phase IIb study assessed the activity of DTG in HIV-1—infected subjects with genotypic evidence of RAL re...

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Published inThe Journal of infectious diseases Vol. 207; no. 5; pp. 740 - 748
Main Authors Eron, Joseph J., Clotet, Bonaventura, Durant, Jacques, Katlama, Christine, Kumar, Princy, Lazzarin, Adriano, Poizot-Martin, Isabelle, Richmond, Gary, Soriano, Vincent, Ait-Khaled, Mounir, Fujiwara, Tamio, Huang, Jenny, Min, Sherene, Vavro, Cindy, Yeo, Jane
Format Journal Article
LanguageEnglish
Published Oxford Oxford University Press 01.03.2013
Subjects
Adult
Aged
Anti-HIV Agents - administration & dosage
Anti-HIV Agents - adverse effects
Anti-HIV Agents - pharmacology
Antiretroviral Therapy, Highly Active - methods
Biological and medical sciences
Drug Resistance, Viral
Female
Fundamental and applied biological sciences. Psychology
Heterocyclic Compounds, 3-Ring - administration & dosage
Heterocyclic Compounds, 3-Ring - adverse effects
Heterocyclic Compounds, 3-Ring - pharmacology
HIV Infections - drug therapy
HIV Infections - virology
HIV-1 - drug effects
HIV-1 - isolation & purification
Human immunodeficiency virus 1
Human viral diseases
Humans
Infectious diseases
Major and Brief Reports
MAJOR ARTICLES AND BRIEF REPORTS
Male
Medical sciences
Microbiology
Middle Aged
Miscellaneous
Pilot Projects
Plasma - virology
Pyrrolidinones - pharmacology
Raltegravir Potassium
RNA, Viral - blood
Treatment Outcome
Viral diseases
Viral diseases of the lymphoid tissue and the blood. Aids
Viral Load
Virology
Young Adult
Immunopathology
Antiretroviral agent
HIV-1 virus
Retroviridae
AIDS
Immune deficiency
Lentivirus
Virus
Infection
Resistance
Integrase inhibitor
Treatment
Efficiency
Viral disease
Antiviral
Human immunodeficiency virus
Raltegravir
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Abstract Background. Dolutegravir (DTG; S/GSK1349572), a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, has limited cross-resistance to raltegravir (RAL) and elvitegravir in vitro. This phase IIb study assessed the activity of DTG in HIV-1—infected subjects with genotypic evidence of RAL resistance. Methods. Subjects received DTG 50 mg once daily (cohort I) or 50 mg twice daily (cohort II) while continuing a failing regimen (without RAL) through day 10, after which the background regimen was optimized, when feasible, for cohort I, and at least 1 fully active drug was mandated for cohort II. The primary efficacy end point was the proportion of subjects on day 11 in whom the plasma HIV-1 RNA load decreased by ≥0.7 log10 copies/mL from baseline or was <400 copies/mL. Results. A rapid antiviral response was observed. More subjects achieved the primary end point in cohort II (23 of 24 [96%]), compared with cohort I (21 of 27 [78%]) at day 11. At week 24, 41% and 75% of subjects had an HIV-1 RNA load of <50 copies/mL in cohorts I and II, respectively. Further integrase genotypic evolution was uncommon. Dolutegravir had a good, similar safety profile with each dosing regimen. Conclusion. Dolutegravir 50 mg twice daily with an optimized background provided greater and more durable benefit than the once-daily regimen. These data are the first clinical demonstration of the activity of any integrase inhibitor in subjects with HIV-1 resistant to RAL.
AbstractList Background.  Dolutegravir (DTG; S/GSK1349572), a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, has limited cross-resistance to raltegravir (RAL) and elvitegravir in vitro. This phase IIb study assessed the activity of DTG in HIV-1–infected subjects with genotypic evidence of RAL resistance. Methods.  Subjects received DTG 50 mg once daily (cohort I) or 50 mg twice daily (cohort II) while continuing a failing regimen (without RAL) through day 10, after which the background regimen was optimized, when feasible, for cohort I, and at least 1 fully active drug was mandated for cohort II. The primary efficacy end point was the proportion of subjects on day 11 in whom the plasma HIV-1 RNA load decreased by ≥0.7 log 10 copies/mL from baseline or was <400 copies/mL. Results.  A rapid antiviral response was observed. More subjects achieved the primary end point in cohort II (23 of 24 [96%]), compared with cohort I (21 of 27 [78%]) at day 11. At week 24, 41% and 75% of subjects had an HIV-1 RNA load of <50 copies/mL in cohorts I and II, respectively. Further integrase genotypic evolution was uncommon. Dolutegravir had a good, similar safety profile with each dosing regimen. Conclusion.  Dolutegravir 50 mg twice daily with an optimized background provided greater and more durable benefit than the once-daily regimen. These data are the first clinical demonstration of the activity of any integrase inhibitor in subjects with HIV-1 resistant to RAL.
Dolutegravir (DTG; S/GSK1349572), a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, has limited cross-resistance to raltegravir (RAL) and elvitegravir in vitro. This phase IIb study assessed the activity of DTG in HIV-1-infected subjects with genotypic evidence of RAL resistance. Subjects received DTG 50 mg once daily (cohort I) or 50 mg twice daily (cohort II) while continuing a failing regimen (without RAL) through day 10, after which the background regimen was optimized, when feasible, for cohort I, and at least 1 fully active drug was mandated for cohort II. The primary efficacy end point was the proportion of subjects on day 11 in whom the plasma HIV-1 RNA load decreased by ≥0.7 log(10) copies/mL from baseline or was <400 copies/mL. A rapid antiviral response was observed. More subjects achieved the primary end point in cohort II (23 of 24 [96%]), compared with cohort I (21 of 27 [78%]) at day 11. At week 24, 41% and 75% of subjects had an HIV-1 RNA load of <50 copies/mL in cohorts I and II, respectively. Further integrase genotypic evolution was uncommon. Dolutegravir had a good, similar safety profile with each dosing regimen. Dolutegravir 50 mg twice daily with an optimized background provided greater and more durable benefit than the once-daily regimen. These data are the first clinical demonstration of the activity of any integrase inhibitor in subjects with HIV-1 resistant to RAL.
Background. Dolutegravir (DTG; S/GSK1349572), a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, has limited cross-resistance to raltegravir (RAL) and elvitegravir in vitro. This phase IIb study assessed the activity of DTG in HIV-1—infected subjects with genotypic evidence of RAL resistance. Methods. Subjects received DTG 50 mg once daily (cohort I) or 50 mg twice daily (cohort II) while continuing a failing regimen (without RAL) through day 10, after which the background regimen was optimized, when feasible, for cohort I, and at least 1 fully active drug was mandated for cohort II. The primary efficacy end point was the proportion of subjects on day 11 in whom the plasma HIV-1 RNA load decreased by ≥0.7 log10 copies/mL from baseline or was <400 copies/mL. Results. A rapid antiviral response was observed. More subjects achieved the primary end point in cohort II (23 of 24 [96%]), compared with cohort I (21 of 27 [78%]) at day 11. At week 24, 41% and 75% of subjects had an HIV-1 RNA load of <50 copies/mL in cohorts I and II, respectively. Further integrase genotypic evolution was uncommon. Dolutegravir had a good, similar safety profile with each dosing regimen. Conclusion. Dolutegravir 50 mg twice daily with an optimized background provided greater and more durable benefit than the once-daily regimen. These data are the first clinical demonstration of the activity of any integrase inhibitor in subjects with HIV-1 resistant to RAL.
Dolutegravir (DTG; S/GSK1349572), a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, has limited cross-resistance to raltegravir (RAL) and elvitegravir in vitro. This phase IIb study assessed the activity of DTG in HIV-1-infected subjects with genotypic evidence of RAL resistance.BACKGROUNDDolutegravir (DTG; S/GSK1349572), a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, has limited cross-resistance to raltegravir (RAL) and elvitegravir in vitro. This phase IIb study assessed the activity of DTG in HIV-1-infected subjects with genotypic evidence of RAL resistance.Subjects received DTG 50 mg once daily (cohort I) or 50 mg twice daily (cohort II) while continuing a failing regimen (without RAL) through day 10, after which the background regimen was optimized, when feasible, for cohort I, and at least 1 fully active drug was mandated for cohort II. The primary efficacy end point was the proportion of subjects on day 11 in whom the plasma HIV-1 RNA load decreased by ≥0.7 log(10) copies/mL from baseline or was <400 copies/mL.METHODSSubjects received DTG 50 mg once daily (cohort I) or 50 mg twice daily (cohort II) while continuing a failing regimen (without RAL) through day 10, after which the background regimen was optimized, when feasible, for cohort I, and at least 1 fully active drug was mandated for cohort II. The primary efficacy end point was the proportion of subjects on day 11 in whom the plasma HIV-1 RNA load decreased by ≥0.7 log(10) copies/mL from baseline or was <400 copies/mL.A rapid antiviral response was observed. More subjects achieved the primary end point in cohort II (23 of 24 [96%]), compared with cohort I (21 of 27 [78%]) at day 11. At week 24, 41% and 75% of subjects had an HIV-1 RNA load of <50 copies/mL in cohorts I and II, respectively. Further integrase genotypic evolution was uncommon. Dolutegravir had a good, similar safety profile with each dosing regimen.RESULTSA rapid antiviral response was observed. More subjects achieved the primary end point in cohort II (23 of 24 [96%]), compared with cohort I (21 of 27 [78%]) at day 11. At week 24, 41% and 75% of subjects had an HIV-1 RNA load of <50 copies/mL in cohorts I and II, respectively. Further integrase genotypic evolution was uncommon. Dolutegravir had a good, similar safety profile with each dosing regimen.Dolutegravir 50 mg twice daily with an optimized background provided greater and more durable benefit than the once-daily regimen. These data are the first clinical demonstration of the activity of any integrase inhibitor in subjects with HIV-1 resistant to RAL.CONCLUSIONDolutegravir 50 mg twice daily with an optimized background provided greater and more durable benefit than the once-daily regimen. These data are the first clinical demonstration of the activity of any integrase inhibitor in subjects with HIV-1 resistant to RAL.
Background. Dolutegravir (DTG; S/GSK1349572), a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, has limited cross-resistance to raltegravir (RAL) and elvitegravir in vitro. This phase IIb study assessed the activity of DTG in HIV-1-infected subjects with genotypic evidence of RAL resistance. Methods. Subjects received DTG 50 mg once daily (cohort I) or 50 mg twice daily (cohort II) while continuing a failing regimen (without RAL) through day 10, after which the background regimen was optimized, when feasible, for cohort I, and at least 1 fully active drug was mandated for cohort II. The primary efficacy end point was the proportion of subjects on day 11 in whom the plasma HIV-1 RNA load decreased by > or =0.7 log sub(10) copies/mL from baseline or was <400 copies/mL. Results. A rapid antiviral response was observed. More subjects achieved the primary end point in cohort II (23 of 24 [96%]), compared with cohort I (21 of 27 [78%]) at day 11. At week 24, 41% and 75% of subjects had an HIV-1 RNA load of <50 copies/mL in cohorts I and II, respectively. Further integrase genotypic evolution was uncommon. Dolutegravir had a good, similar safety profile with each dosing regimen. Conclusion. Dolutegravir 50 mg twice daily with an optimized background provided greater and more durable benefit than the once-daily regimen. These data are the first clinical demonstration of the activity of any integrase inhibitor in subjects with HIV-1 resistant to RAL.
Author Min, Sherene
Lazzarin, Adriano
Eron, Joseph J.
Soriano, Vincent
Ait-Khaled, Mounir
Fujiwara, Tamio
Clotet, Bonaventura
Katlama, Christine
Kumar, Princy
Poizot-Martin, Isabelle
Yeo, Jane
Richmond, Gary
Durant, Jacques
Vavro, Cindy
Huang, Jenny
AuthorAffiliation 13 GlaxoSmithKline, Toronto , Canada
10 San Raffaele Scientific Institute , Milan , Italy
6 Hospital Carlos III , Madrid , Spain
9 APHM Sainte-Marguerite , Aix Marseille University , Marseille , France
8 Hôpital de la Pitié-Salpêtrière , Paris VI University , Paris, France
3 Georgetown University , Washington, D.C
11 GlaxoSmithKline, London , United Kingdom
2 GlaxoSmithKline , Research Triangle Park , North Carolina
4 Broward Health, Fort Lauderdale, Florida
12 Shionogi & Co Ltd, Osaka , Japan
1 Infectious Diseases Division , School of Medicine , University of North Carolina, Chapel Hill
5 Hospital Germans Trias i Pujol, Irsicaixa Foundation, Barcelona, France
7 Hôpital de l'Archet 1, Nice, France
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– name: 11 GlaxoSmithKline, London , United Kingdom
– name: 2 GlaxoSmithKline , Research Triangle Park , North Carolina
– name: 8 Hôpital de la Pitié-Salpêtrière , Paris VI University , Paris, France
– name: 9 APHM Sainte-Marguerite , Aix Marseille University , Marseille , France
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https://www.ncbi.nlm.nih.gov/pubmed/23225901$$D View this record in MEDLINE/PubMed
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10.1093/jac/dkq350
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ContentType Journal Article
Contributor Fernández, Pompeyo Viciana
Devente, Jerome
Vittecoq, Daniel
Walmsley, Sharon L
Young, Benjamin
Dejesus, Edwin
Hawkins, Trevor
Lalezari, Jacob P
Livrozet, Jean-Michel
Lamarca, Anthony
Gatell, Jose M
McCurdy, Lewis H
Cox, Joseph
Morlat, Philippe
Reynes, Jacques
Sloan, Louis A
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Copyright Copyright © 2013 Oxford University Press on behalf of the Infectious Diseases Society of America
2014 INIST-CNRS
The Author 2012. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. 2012
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ISSN 0022-1899
1537-6613
IngestDate Thu Aug 21 18:18:25 EDT 2025
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Fri Jul 11 13:57:26 EDT 2025
Mon Jul 21 05:56:44 EDT 2025
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Thu Apr 24 23:06:19 EDT 2025
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IsDoiOpenAccess true
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IsScholarly true
Issue 5
Keywords Immunopathology
Antiretroviral agent
HIV-1 virus
Retroviridae
AIDS
Immune deficiency
Lentivirus
Virus
Infection
Resistance
Integrase inhibitor
Treatment
Efficiency
Viral disease
Antiviral
Human immunodeficiency virus
Raltegravir
Language English
License CC BY 4.0
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
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Notes ObjectType-Article-2
SourceType-Scholarly Journals-1
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content type line 23
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Presented in part: 13th European AIDS Conference, Belgrade, Serbia, 12–15 October 2011, Abstract PS1/2; 18th Conference on Retroviruses and Opportunistic Infections, Boston, Massachusetts, 27 February–2 March 2011, Abstract L-1005; 10th International Congress on Drug Therapy in HIV Infection, Glasgow, United Kingdom, 7–11 November 2010, Abstract O51; 18th International AIDS Conference, Vienna, Austria, 18–23 July 2010, Abstract MOAB0105.
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PublicationTitle The Journal of infectious diseases
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Snippet Background. Dolutegravir (DTG; S/GSK1349572), a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, has limited cross-resistance to raltegravir...
Dolutegravir (DTG; S/GSK1349572), a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, has limited cross-resistance to raltegravir (RAL) and...
Background.  Dolutegravir (DTG; S/GSK1349572), a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, has limited cross-resistance to raltegravir...
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jstor
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Aggregation Database
Index Database
Enrichment Source
Publisher
StartPage 740
SubjectTerms Adult
Aged
Anti-HIV Agents - administration & dosage
Anti-HIV Agents - adverse effects
Anti-HIV Agents - pharmacology
Antiretroviral Therapy, Highly Active - methods
Biological and medical sciences
Drug Resistance, Viral
Female
Fundamental and applied biological sciences. Psychology
Heterocyclic Compounds, 3-Ring - administration & dosage
Heterocyclic Compounds, 3-Ring - adverse effects
Heterocyclic Compounds, 3-Ring - pharmacology
HIV Infections - drug therapy
HIV Infections - virology
HIV-1 - drug effects
HIV-1 - isolation & purification
Human immunodeficiency virus 1
Human viral diseases
Humans
Infectious diseases
Major and Brief Reports
MAJOR ARTICLES AND BRIEF REPORTS
Male
Medical sciences
Microbiology
Middle Aged
Miscellaneous
Pilot Projects
Plasma - virology
Pyrrolidinones - pharmacology
Raltegravir Potassium
RNA, Viral - blood
Treatment Outcome
Viral diseases
Viral diseases of the lymphoid tissue and the blood. Aids
Viral Load
Virology
Young Adult
Title Safety and Efficacy of Dolutegravir in Treatment-Experienced Subjects With Raltegravir-Resistant HIV Type 1 Infection: 24-Week Results of the VIKING Study
URI https://www.jstor.org/stable/23354743
https://www.ncbi.nlm.nih.gov/pubmed/23225901
https://www.proquest.com/docview/1285465404
https://www.proquest.com/docview/1654670825
https://pubmed.ncbi.nlm.nih.gov/PMC3563307
Volume 207
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