Effect of dolutegravir functional monotherapy on HIV-1 virological response in integrase strand transfer inhibitor resistant patients

Antiviral Therapy

Volumn 21, Issue 6, 2016, Pages 481-488

  Naeger, Lisa K ^a   Harrington, Patrick ^a   Komatsu, Takashi ^a   Deming, Damon ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DOLUTEGRAVIR; ELVITEGRAVIR; INTEGRASE; NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR; PLACEBO; PROTEINASE INHIBITOR; RALTEGRAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; FUSED HETEROCYCLIC RINGS; INTEGRASE INHIBITOR;

AMINO ACID SUBSTITUTION; ANTIVIRAL RESISTANCE; ANTIVIRAL SUSCEPTIBILITY; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG EFFECT; DRUG RESPONSE; DRUG TREATMENT FAILURE; GENOTYPE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; MONOTHERAPY; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PHENOTYPE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; ADULT; CLINICAL TRIAL; DRUG ADMINISTRATION; DRUG EFFECTS; FEMALE; GENETICS; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MALE; TREATMENT FAILURE; VIROLOGY;

ADULT; AMINO ACID SUBSTITUTION; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, VIRAL; FEMALE; HETEROCYCLIC COMPOUNDS, 3-RING; HIV INFECTIONS; HIV INTEGRASE; HIV INTEGRASE INHIBITORS; HIV-1; HUMANS; MALE; TREATMENT FAILURE;

EID: 84996995640     PISSN: 13596535     EISSN: 20402058     Source Type: Journal    
DOI: 10.3851/IMP3033     Document Type: Article

References (5)

1. Kobayashi M, Yoshinaga T, Seki T, et al. In vitro antiretroviral properties of S/GSK1349572, a next generation HIV integrase inhibitor. Antimicrob Agents Chemother 2011; 55:813-821.
2. Tivicay (dolutegravir). US Package insert 2015, ViiV Healthcare, Research Triangle Park, NC, USA. (Accessed 14 October 2015.) Available from http://www.accessdata.fda.gov/drugsatfda-docs/label/2013/204790lbl.pdf
3. Castagna A, Maggiolo F, Penco G, et al. Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the Phase III VIKING-3 study. J Infect Dis 2014; 210:354-362.
4. Akil B, Blick G, Hagins D, et al. Dolutegravir versus placebo in patients harbouring HIV-1 with integrase inhibitor resistance associated substitutions: 48-week results from VIKING-4, a randomized study. Antivir Ther 2015; 20:343-348.
5. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry: human immunodeficiency virus-1 infection: developing antiretroviral drugs for treatment, June 2013. (Accessed 12 November 2015.) Available from http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm355128.pdf