Author | Cahn, Pedro | |
Author | Pozniak, Anton L. | |
Author | Mingrone, Horacio | |
Author | Shuldyakov, Andrey | |
Author | Brites, Carlos | |
Author | Andrade-Villanueva, Jaime F. | |
Author | Richmond, Gary | |
Author | Buendia, Carlos Beltran | |
Author | Fourie, Jan | |
Author | Ramgopal, Moti | |
Author | Hagins, Debbie | |
Author | Felizarta, Franco | |
Author | Madruga, Jose | |
Author | Reuter, Tania | |
Author | Newman, Tamara | |
Author | Small, Catherine B. | |
Author | Lombaard, John | |
Author | Grinsztejn, Beatriz | |
Author | Dorey, David | |
Author | Underwood, Mark | |
Author | Griffith, Sandy | |
Author | Min, Sherene | |
Author | SAILING Study Team | |
Access date | 2019-01-29T11:43:41Z | |
Available date | 2019-01-29T11:43:41Z | |
Document date | 2013 | |
Citation | CAHN, Pedro et al. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet, v. 382, n. 9893, p. 700-708, Aug. 2013. | pt_BR |
ISSN | 0140-6736 | pt_BR |
URI | https://www.arca.fiocruz.br/handle/icict/31330 | |
Description | Fundacion Huesped, Buenos Aires, Argentina (P Cahn MD); Chelsea and Westminster Hospital NHS Foundation Trust, London, UK (A L Pozniak MD); Fundacion IDEAA, Buenos Aires, Argentina(H Mingrone MD); Saratov Regional Centre of Prophylactic AIDS, Saratov, Russia (A Shuldyakov MD); Complexo Hospitalar Prof Edgard Santos, Universidade Federal da Bahia, Salvador, Brazil (C Brites MD); Hospital Civil de Guadalajara, “Fray Antonio Alcalde” CUCS, Universidad de Guadalajara, Guadalajara, Mexico (J F Andrade-Villanueva MD); Broward Health Medical Center, Fort Lauderdale, FL, USA (G Richmond MD); Hospital
Barros Luco Trudeau, Santiago, Chile (C Beltran Buendia MD); Fourie Medical Centre, Dundee,
South Africa (J Fourie MD); Midway Immunology and Research Center, Fort Pierce, FL, USA (M Ramgopal MD); Chatham CARE Center, Savannah, GA, USA (D Hagins MD); Private practice, Bakersville, CA, USA
(F Felizarta MD); Centro de Referencia e Treinamento DST/AIDS, São Paulo, Brazil (J Madruga MD); Universidade Federal do Espirito Santo, Vitoria, Brazil (T Reuter MD); Instituto de Infectologia Emilio
Ribas, São Paulo, Brazil; (T Newman MD); New York Medical College, Valhalla, NY, USA (C B Small MD); JOSHA Research, Bloemfontein, South Africa (J Lombaard MD); Inst de Pesquisa Clinica Evandro Chagas Fiocruz, Rio de Janeiro, Brazil (B Grinsztejn MD); GlaxoSmithKline, Mississauga, ON, Canada (D Dorey MMath); GlaxoSmithKline, Research Triangle Park, NC, USA (M Underwood PhD, S Griffi th PharmD, S Min MD). | pt_BR |
Description | Beatriz Grinsztejn - Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | |
Language | eng | pt_BR |
Publisher | Elsevier | pt_BR |
Rights | restricted access | pt_BR |
Title | Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study | pt_BR |
Type | Article | |
DOI | 10.1016/S0140-6736(13)61221-0 | |
Abstract | Background: Dolutegravir (GSK1349572), a once-daily HIV integrase inhibitor, has shown potent antiviral response and a favourable safety profi le. We evaluated safety, effi cacy, and emergent resistance in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV-1 with at least two-class drug resistance. Methods: ING111762 (SAILING) is a 48 week, phase 3, randomised, double-blind, active-controlled, non-inferiority study that began in October, 2010. Eligible patients had two consecutive plasma HIV-1 RNA assessments of 400 copies per mL or higher (unless >1000 copies per mL at screening), resistance to two or more classes of antiretroviral drugs, and had one to two fully active drugs for background therapy. Participants were randomly assigned (1:1) to once-daily dolutegravir 50 mg or twice-daily raltegravir 400 mg, with investigator-selected background therapy. Matching placebo was given, and study sites were masked to treatment assignment. The primary endpoint was the proportion of patients with plasma HIV-1 RNA less than 50 copies per mL at week 48, evaluated in all participants randomly
assigned to treatment groups who received at least one dose of study drug, excluding participants at one site with violations of good clinical practice. Non-inferiority was prespecifi ed with a 12% margin; if non-inferiority was established, then superiority would be tested per a prespecifi ed sequential testing procedure. A key prespecifi ed
secondary endpoint was the proportion of patients with treatment-emergent integrase-inhibitor resistance. The trial is registered at ClinicalTrials.gov, NCT01231516. Findings Analysis included 715 patients (354 dolutegravir; 361 raltegravir). At week 48, 251 (71%) patients on
dolutegravir had HIV-1 RNA less than 50 copies per mL versus 230 (64%) patients on raltegravir (adjusted diff erence 7·4%, 95% CI 0·7 to 14·2); superiority of dolutegravir versus raltegravir was then concluded (p=0·03).
Signifi cantly fewer patients had virological failure with treatment-emergent integrase-inhibitor resistance on dolutegravir (four vs 17 patients; adjusted diff erence –3·7%, 95% CI –6·1 to –1·2; p=0·003). Adverse event frequencies were similar across groups; the most commonly reported events for dolutegravir versus raltegravir were diarrhoea (71 [20%] vs 64 [18%] patients), upper respiratory tract infection (38 [11%] vs 29 [8%]), and headache (33 [9%] vs 31 [9%]).
Safety events leading to discontinuation were infrequent in both groups (nine [3%] dolutegravir, 14 [4%] raltegravir). Interpretation: Once-daily dolutegravir, in combination with up to two other antiretroviral drugs, is well tolerated with greater virological eff ect compared with twice-daily raltegravir in this treatment-experienced patient group. Funding: ViiV Healthcare. | pt_BR |
Affilliation | Múltipla - ver em Notas | pt_BR |
Subject | Dolutegravir | pt_BR |
Subject | Raltegravir | pt_BR |
Subject | Antiretroviral | pt_BR |
Subject | HIV | pt_BR |
e-ISSN | 2352-3018 | |