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

Data de publicació: 01/11/2015

Autors de IIS La Fe

Miguel Masia Massoni

Autor
Miguel Salavert Lletí

Autor

Autors aliens a IIS La Fe

Santos JR
Blanco JL
Gutiérrez F
Pérez-Elías MJ
Iribarren JA
Force L
Antela A
Knobel H
López Bernaldo De Quirós JC
Pino M
Paredes R
Clotet B
Integrase Resistance Study Group in Spain (INI-VAIN Study Group)
Integrase Resistance Study Group in Spain INI-VAIN Study Group

Grups d'Investigació

Infección Grave

Investigador Principal

María Ángeles Tormo Mas

Abstract

Objectives: The objective of this study was to evaluate the incidence, prevalence and clinical consequences of virological failure (VF) to raltegravir-based regimens in Spain. Methods: 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 <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. Results: Of the 15009 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. Conclusions: VF with raltegravir is infrequent, but often associated with major clinical complications in treatment-experienced patients.

Dades de la publicació

ISSN/ISSNe:: 0305-7453, 1460-2091
Tipus:: Article
Pàgines:: 3087-3095
DOI:: 10.1093/jac/dkv205
PubMed:: 26490727
Factor d'Impacte:: 2,259 SCImago ℠
Quartil:: Q1 SCImago ℠

Documents

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Mètriques

Filiacions

Blanco JL:: Hospital Clinic de Barcelona, University of Barcelona, IDIBAPS, Barcelona, Spain
Masiá M:: Infectious Diseases Unit, Elche University General Hospital, Elche, Spain Miguel Hernández University, Elche, Spain
Gutiérrez F:: Infectious Diseases Unit, Elche University General Hospital, Elche, Spain Miguel Hernández University, Elche, Spain
Pérez-Elías MJ:: Infectious Diseases Unit, Ramón y Cajal Hospital, IRYCIS, Madrid, Spain
Iribarren JA:: Infectious Diseases Unit, Donostia University Hospital, San Sebastián, Spain
Force L:: Infectious Diseases Unit, Mataró Hospital, Mataró, Spain
Antela A:: Infectious Diseases Unit, University Hospital, Santiago de Compostela, Spain
Knobel H:: Service of Infectious Diseases, Hospital del Mar, IMIM (Hospital del Mar Research Institute), Barcelona, Spain
Salavert M:: Infectious Diseases Unit, La Fe University and Polytechnic Hospital, Valencia, Spain
López Bernaldo De Quirós JC:: Infectious Diseases Unit, Gregorio Marañón University Hospital, Madrid, Spain
Pino M:: IrsiCaixa AIDS Research Institute, Barcelona, Spain
Paredes R:: Lluita contra la SIDA Foundation, Germans Trias i Pujol University Hospital, Barcelona, Spain IrsiCaixa AIDS Research Institute, Barcelona, Spain Universitat de Vic-Universitat Central de Catalunya, Vic, Spain
Clotet B:: Lluita contra la SIDA Foundation, Germans Trias i Pujol University Hospital, Barcelona, Spain Universitat Autònoma de Barcelona, Barcelona, Spain IrsiCaixa AIDS Research Institute, Barcelona, Spain Universitat de Vic-Universitat Central de Catalunya, Vic, Spain