Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/31128
Title: Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial
Authors: Madruga, José Valdez
Cahn, Pedro
Grinsztejn, Beatriz
Haubrich, Richard
Lalezari, Jacob
Mills, Anthony
Pialoux, Gilles
Wilkin, Timothy
Peeters, Monika
Vingerhoets, Johan
de Smedt, Goedele
Leopold, Lorant
Trefiglio, Roberta
Woodfall, Brian
DUET-1 study group
Affilliation: Centro de Referência e Treinamento DST/AIDS. São Paulo, SP, Brasil.
Hospital Juan A. Fernández and Fundación Huesped. Buenos Aires, Argentina.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Rio de Janeiro, RJ, Brasil.
University of California San Diego. San Diego, CA, USA.
Quest Clinical Research. San Francisco, CA, USA.
Private Practice. Los Angeles, CA, USA.
Service des Maladies Infectieuses. Paris, France.
Weill Medical College of Cornell University. New York, NY, USA.
Tibotec BVBA. Mechelen, Belgium.
Tibotec BVBA. Mechelen, Belgium.
Tibotec BVBA. Mechelen, Belgium.
Tibotec In. Yardley, PA, USA.
Tibotec In. Yardley, PA, USA.
Tibotec BVBA. Mechelen, Belgium.
Abstract: Background: Antiretroviral agents active against drug-resistant HIV-1 are needed for treatment-experienced patients. The aim of this trial was to assess the effi cacy, safety, and tolerability of TMC125 (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI). Methods: DUET-1 is a continuing, multinational randomised, double-blind, placebo-controlled, phase III trial. Treatment-experienced adult patients with virological failure on stable antiretroviral therapy, documented genotypic evidence of NNRTI resistance, viral load over 5000 copies per mL, and three or more primary protease inhibitor mutations were randomly assigned to receive 200 mg TMC125 or placebo twice daily. All patients also received darunavir with low-dose ritonavir and investigator-selected nucleoside reverse transcriptase inhibitors. Enfuvirtide use was optional. The primary endpoint was a confi rmed viral load below 50 copies per mL at week 24 (FDA time-toloss of virological response algorithm). Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, with the number NCT00254046. Findings: 612 patients were randomised and treated (304 in the TMC125 group, 308 in the placebo group). By week 24, 42 (14%) patients in the TMC125 group and 56 (18%) in the placebo group had discontinued, mainly due to virological failure. At week 24, 170 (56%) patients in the TMC125 group and 119 (39%) patients in the placebo group achieved a confirmed viral load of less than 50 copies per mL (difference in response rates 17%; 95% CI 9–25; p=0·005). Most adverse events were mild or moderate in severity. The type and incidence of adverse events, including neuropsychiatric events, seen with TMC125 were generally comparable with placebo, with the exception of rash (61 [20%] patients on TMC125 vs 30 [10%] on placebo) and diarrhoea (36 [12%] patients on TMC125 vs 63 [20%] on placebo). Interpretation: In treatment-experienced patients with NNRTI resistance, treatment with TMC125 achieved better virological suppression at week 24 than did placebo. The safety and tolerability profi le of TMC125 was generally comparable with placebo.
Keywords: HIV-1
Etravirine
HIV-1-infected patients in DUET-1
Issue Date: 2007
Publisher: Elsevier
Citation: MADRUGA, José Valdez et al. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial. The Lancet, v. 370, p. 29–38, 2007.
DOI: 10.1016/S0140-6736(07)61047-2
ISSN: 0140-6736
Copyright: restricted access
Appears in Collections:INI - Artigos de Periódicos

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