| Author | Cooper, David A. | |
| Author | Steigbigel, Roy T. | |
| Author | Gatell, Jose M. | |
| Author | Rockstroh, Jurgen K. | |
| Author | Katlama, Christine | |
| Author | Yeni, Patrick | |
| Author | Lazzarin, Adriano | |
| Author | Clotet, Bonaventura | |
| Author | Kumar, Princy N. | |
| Author | Eron, Joseph E. | |
| Author | Schechter, Mauro | |
| Author | Markowitz, Martin | |
| Author | Loutfy, Mona R. | |
| Author | Lennox, Jeffrey L. | |
| Author | Zhao, Jing | |
| Author | Chen, Joshua | |
| Author | Ryan, Desmond M. | |
| Author | Rhodes, Rand R. | |
| Author | Killar, John A. | |
| Author | Gilde, Lucinda R. | |
| Author | Strohmaier, Kim M. | |
| Author | Meibohm, Anne R. | |
| Author | Miller, Michael D. | |
| Author | Hazuda, Daria J. | |
| Author | Nessly, Michael L. | |
| Author | DiNubile, Mark J. | |
| Author | Isaacs, Robin D. | |
| Author | Teppler, Hedy | |
| Author | Nguyen, Bach-Yen | |
| Access date | 2019-01-17T22:21:48Z | |
| Available date | 2019-01-17T22:21:48Z | |
| Document date | 2008 | |
| Citation | COOPER, David A. et al. Subgroup and resistance analyses of Raltegravir for resistant HIV-1 infection. The New England Journal of Medicine, v. 359, n. 4, p. 356-365, July 2008. | pt_BR |
| ISSN | 0028-4793 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/31131 | |
| Description | BENCHMRK Study Teams - Beatriz Grinsztejn - Fundação Oswaldo Cruz - Instituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro, RJ, Brasil. Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta à informação no documento. | pt_BR |
| Language | eng | pt_BR |
| Publisher | Massachusetts Medical Society | pt_BR |
| Rights | restricted access | pt_BR |
| Title | Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection | pt_BR |
| Type | Article | |
| DOI | 10.1056/NEJMoa0708978 | |
| Abstract | Background: We evaluated the efficacy of raltegravir and the development of viral resistance in two identical trials involving patients who were infected with human immunodeficiency virus type 1 (HIV-1) with triple-class drug resistance and in whom antiretroviral therapy had failed. Methods: We conducted subgroup analyses of the data from week 48 in both studies according to baseline prognostic factors. Genotyping of the integrase gene was performed in raltegravir recipients who had virologic failure. Results: Virologic responses to raltegravir were consistently superior to responses to placebo, regardless of the baseline values of HIV-1 RNA level; CD4 cell count; genotypic or phenotypic sensitivity score; use or nonuse of darunavir, enfuvirtide, or both in optimized background therapy; or demographic characteristics. Among patients in the two studies combined who were using both enfuvirtide and darunavir for the first time, HIV-1 RNA levels of less than 50 copies per milliliter were achieved in 89% of raltegravir recipients and 68% of placebo recipients. HIV-1 RNA levels of less than 50 copies per milliliter were achieved in 69% and 80% of the raltegravir recipients and in 47% and 57% of the placebo recipients using either darunavir or enfuvirtide for the first time, respectively. At 48 weeks, 105 of the 462 raltegravir recipients (23%) had virologic failure. Genotyping was performed in 94 raltegravir recipients with virologic failure. Integrase mutations known to be associated with phenotypic resistance to raltegravir arose during treatment in 64 patients (68%). Forty-eight of these 64 patients (75%) had two or more resistance-associated mutations. Conclusions: When combined with an optimized background regimen in both studies, a consistently favorable treatment effect of raltegravir over placebo was shown in clinically relevant subgroups of patients, including those with baseline characteristics that typically predict a poor response to antiretroviral therapy: a high HIV-1 RNA level, low CD4 cell count, and low genotypic or phenotypic sensitivity score. | pt_BR |
| Affilliation | University of New South Wales. National Centre in HIV Epidemiology and Clinical Research. Sydney, Australia. | pt_BR |
| Affilliation | State University of New York. Stony Brook, NY, USA. | pt_BR |
| Affilliation | University of Barcelona. Barcelona, Spain. | pt_BR |
| Affilliation | University of Bonn. Bonn, Germany. | pt_BR |
| Affilliation | Université Pierre et Marie Curie. Hospital Pitié–Salpêtrière. Paris, France. | pt_BR |
| Affilliation | Hospital Bichat–Claude Bernard. Paris, France. | pt_BR |
| Affilliation | San Raffaele Scientific Institute. Milan, Italia. | pt_BR |
| Affilliation | Hospital Germans Trias i Pujol. Fundación Irsicaixa. Barcelona, Spain. | pt_BR |
| Affilliation | Georgetown University Medical Center. Washington, DC, USA. | pt_BR |
| Affilliation | University of North Carolina. Chapel Hill, ND, USA. | pt_BR |
| Affilliation | Universidade Federal do Rio de Janeiro. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Rockefeller University. Diamond Research Center. New York, NY, USA. | pt_BR |
| Affilliation | University of Toronto. Toronto, ON, Canada. | pt_BR |
| Affilliation | Emory University School of Medicine. Atlanta, GA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Affilliation | Merck Research Laboratories. North Wales, PA, USA. | pt_BR |
| Subject | HIV-1 | pt_BR |
| Subject | Resistant HIV-1 infection | pt_BR |
| Subject | Raltegravir | pt_BR |
| e-ISSN | 1533-4406 | |
| Embargo date | 2030-12-31 | |
