TY - JOUR
T1 - Virological failure to raltegravir in Spain: Incidence, prevalence and clinical consequences
AU - Santos, José Ramón
AU - Blanco, José Luis
AU - Masiá, Mar
AU - Gutiérrez, Félix
AU - Pérez-Elías, María Jesús
AU - Iribarren, José Antonio
AU - Force, Lluis
AU - Antela, Antonio
AU - Knobel, Hernando
AU - Salavert, Miguel
AU - De Quirós, Juan Carlos López Bernaldo
AU - Pino, María
AU - Paredes, Roger
AU - Clotet, Bonaventura
AU - Bravo, Isabel
AU - Martínez-Picado, Javier
AU - Rojas, John F.
AU - Gatell, José M.
AU - Díaz, Alberto
AU - Gutiérrez, Carolina
AU - Galán, Juan Carlos
AU - Moreno, Santiago
AU - Ibarguren, Maialen
AU - Barrufet, Pilar
AU - Losada, Elena
AU - Aguilera, Antonio
AU - Gonzalez, Alicia
AU - Molina, José Miguel
AU - Carrero, Ana
PY - 2015/1/1
Y1 - 2015/1/1
N2 - © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. 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 raltegravirbased treatments as salvage regimens. Conclusions: VF with raltegravir is infrequent, but often associated with major clinical complications in treatment-experienced patients.
AB - © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. 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 raltegravirbased treatments as salvage regimens. Conclusions: VF with raltegravir is infrequent, but often associated with major clinical complications in treatment-experienced patients.
U2 - 10.1093/jac/dkv205
DO - 10.1093/jac/dkv205
M3 - Article
VL - 70
SP - 3087
EP - 3095
IS - 11
ER -