Virological failure to raltegravir in Spain: incidence, prevalence and clinical consequences

The objective of this study was to evaluate the incidence, prevalence and clinical consequences of virological failure (VF) to raltegravir-based regimens in Spain. A multicentre, retrospective, observational study was performed in 10 tertiary hospitals (January 2006 to June 2013). The study included...

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Veröffentlicht in:Journal of antimicrobial chemotherapy 2015-11, Vol.70 (11), p.3087-3095
Hauptverfasser: Santos, José Ramón, Blanco, José Luis, Masiá, Mar, Gutiérrez, Félix, Pérez-Elías, María Jesús, Iribarren, José Antonio, Force, Lluis, Antela, Antonio, Knobel, Hernando, Salavert, Miguel, López Bernaldo De Quirós, Juan Carlos, Pino, María, Paredes, Roger, Clotet, Bonaventura
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container_end_page 3095
container_issue 11
container_start_page 3087
container_title Journal of antimicrobial chemotherapy
container_volume 70
creator Santos, José Ramón
Blanco, José Luis
Masiá, Mar
Gutiérrez, Félix
Pérez-Elías, María Jesús
Iribarren, José Antonio
Force, Lluis
Antela, Antonio
Knobel, Hernando
Salavert, Miguel
López Bernaldo De Quirós, Juan Carlos
Pino, María
Paredes, Roger
Clotet, Bonaventura
description The objective of this study was to evaluate the incidence, prevalence and clinical consequences of virological failure (VF) to raltegravir-based regimens in Spain. A multicentre, retrospective, observational study was performed in 10 tertiary hospitals (January 2006 to June 2013). The study included HIV-1-infected patients with loss of virological suppression (LVS; two consecutive HIV-1 RNA ≥50 copies/mL) while receiving raltegravir. VF and low-level viraemia (LLV) were defined as two consecutive HIV-1 RNA ≥200 copies/mL and 50 to
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A multicentre, retrospective, observational study was performed in 10 tertiary hospitals (January 2006 to June 2013). The study included HIV-1-infected patients with loss of virological suppression (LVS; two consecutive HIV-1 RNA ≥50 copies/mL) while receiving raltegravir. VF and low-level viraemia (LLV) were defined as two consecutive HIV-1 RNA ≥200 copies/mL and 50 to &lt;200 copies/mL, respectively. Integrase strand-transfer inhibitor resistance was investigated at LVS. During the 48 weeks following LVS, recorded data included clinical characteristics, treatment discontinuations, AIDS-associated events and deaths. Effectiveness of therapy following LVS was evaluated by ITT and PP. Multivariate regression was used to assess predictors of efficacy. Of the 15 009 HIV-infected patients in participating centres, 2782 (18.5%) had received raltegravir-based regimens. Of those, 192 (6.9%), 125 (4.5%) and 67 (2.4%) experienced LVS, VF and LLV, respectively. The incidence of VF was 1.8 (95% CI, 1.5-2.1) per 100 patients/year. The prevalence of VF was 4.5% (95% CI, 3.8%-5.3%). Integrase-associated mutations were found in 78.8% of patients with integrase genotyping results available. High-level resistance to dolutegravir was not observed. Salvage therapy failed in 34.1% of patients; progression to AIDS/death occurred in 8.3% during the first year following LVS. The latter was associated with intravenous drug use, time on raltegravir and lower CD4+ count nadir in patients who started raltegravir-based treatments as salvage regimens. VF with raltegravir is infrequent, but often associated with major clinical complications in treatment-experienced patients.</description><identifier>ISSN: 0305-7453</identifier><identifier>EISSN: 1460-2091</identifier><identifier>DOI: 10.1093/jac/dkv205</identifier><identifier>PMID: 26490727</identifier><language>eng</language><publisher>England: Oxford Publishing Limited (England)</publisher><subject>Anti-HIV Agents - therapeutic use ; Antiretroviral drugs ; Drug resistance ; Drug Resistance, Viral ; Genotype ; HIV ; HIV Infections - drug therapy ; HIV Infections - virology ; HIV-1 - drug effects ; HIV-1 - genetics ; HIV-1 - isolation &amp; purification ; Human immunodeficiency virus ; Human immunodeficiency virus 1 ; Humans ; Incidence ; Inhibitor drugs ; Prevalence ; Raltegravir Potassium - therapeutic use ; Retrospective Studies ; Ribonucleic acid ; RNA ; Spain ; Tertiary Care Centers ; Treatment Failure ; Viral Load ; Virology</subject><ispartof>Journal of antimicrobial chemotherapy, 2015-11, Vol.70 (11), p.3087-3095</ispartof><rights>The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.</rights><rights>Copyright Oxford Publishing Limited(England) Nov 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c384t-48d25ae536acc98f7340bf705174499ab4fe99517c82993596276e176c62ab3a3</citedby><cites>FETCH-LOGICAL-c384t-48d25ae536acc98f7340bf705174499ab4fe99517c82993596276e176c62ab3a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26490727$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Santos, José Ramón</creatorcontrib><creatorcontrib>Blanco, José Luis</creatorcontrib><creatorcontrib>Masiá, Mar</creatorcontrib><creatorcontrib>Gutiérrez, Félix</creatorcontrib><creatorcontrib>Pérez-Elías, María Jesús</creatorcontrib><creatorcontrib>Iribarren, José Antonio</creatorcontrib><creatorcontrib>Force, Lluis</creatorcontrib><creatorcontrib>Antela, Antonio</creatorcontrib><creatorcontrib>Knobel, Hernando</creatorcontrib><creatorcontrib>Salavert, Miguel</creatorcontrib><creatorcontrib>López Bernaldo De Quirós, Juan Carlos</creatorcontrib><creatorcontrib>Pino, María</creatorcontrib><creatorcontrib>Paredes, Roger</creatorcontrib><creatorcontrib>Clotet, Bonaventura</creatorcontrib><creatorcontrib>Integrase Resistance Study Group in Spain (INI-VAIN Study Group)</creatorcontrib><creatorcontrib>Integrase Resistance Study Group in Spain INI-VAIN Study Group</creatorcontrib><title>Virological failure to raltegravir in Spain: incidence, prevalence and clinical consequences</title><title>Journal of antimicrobial chemotherapy</title><addtitle>J Antimicrob Chemother</addtitle><description>The objective of this study was to evaluate the incidence, prevalence and clinical consequences of virological failure (VF) to raltegravir-based regimens in Spain. A multicentre, retrospective, observational study was performed in 10 tertiary hospitals (January 2006 to June 2013). The study included HIV-1-infected patients with loss of virological suppression (LVS; two consecutive HIV-1 RNA ≥50 copies/mL) while receiving raltegravir. VF and low-level viraemia (LLV) were defined as two consecutive HIV-1 RNA ≥200 copies/mL and 50 to &lt;200 copies/mL, respectively. Integrase strand-transfer inhibitor resistance was investigated at LVS. During the 48 weeks following LVS, recorded data included clinical characteristics, treatment discontinuations, AIDS-associated events and deaths. Effectiveness of therapy following LVS was evaluated by ITT and PP. Multivariate regression was used to assess predictors of efficacy. Of the 15 009 HIV-infected patients in participating centres, 2782 (18.5%) had received raltegravir-based regimens. Of those, 192 (6.9%), 125 (4.5%) and 67 (2.4%) experienced LVS, VF and LLV, respectively. 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source Oxford University Press Journals All Titles (1996-Current); MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection; Free Full-Text Journals in Chemistry
subjects Anti-HIV Agents - therapeutic use
Antiretroviral drugs
Drug resistance
Drug Resistance, Viral
Genotype
HIV
HIV Infections - drug therapy
HIV Infections - virology
HIV-1 - drug effects
HIV-1 - genetics
HIV-1 - isolation & purification
Human immunodeficiency virus
Human immunodeficiency virus 1
Humans
Incidence
Inhibitor drugs
Prevalence
Raltegravir Potassium - therapeutic use
Retrospective Studies
Ribonucleic acid
RNA
Spain
Tertiary Care Centers
Treatment Failure
Viral Load
Virology
title Virological failure to raltegravir in Spain: incidence, prevalence and clinical consequences
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