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Ritonavir-boosted d...
Ritonavir-boosted darunavir combined with raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults infected with HIV-1 : 96 week results from the NEAT001/ANRS143 randomised non-inferiority trial
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- Raffi, François (author)
- University of Nantes
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- Babiker, Abdel G. (author)
- University College London
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- Richert, Laura (author)
- University of Bordeaux
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- Molina, Jean-Michel (author)
- Paris Diderot University,Saint-Louis Hospital, Paris
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- George, Elizabeth C. (author)
- University College London
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- Antinori, Andrea (author)
- Lazzaro Spallanzani National Institute for Infectious Diseases
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- Arribas, Jose R (author)
- University Hospital La Paz
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- Grarup, Jesper (author)
- University of Copenhagen,Copenhagen University Hospital
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- Hudson, Fleur (author)
- University College London
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- Schwimmer, Christine (author)
- University of Bordeaux
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- Saillard, Juliette (author)
- ANRS - France Recherche Nord & Sud Sida-HIV Hépatites virales
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- Wallet, Cédrick (author)
- University of Bordeaux
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- Jansson, Per O. (author)
- University of Copenhagen
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- Allavena, Clotilde (author)
- University of Nantes
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- Van Leeuwen, Remko (author)
- Academic Medical Center of University of Amsterdam (AMC),Amsterdam Institute for Global Health and Development
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- Delfraissy, Jean-François (author)
- Bicêtre Hospital
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- Vella, Stefano (author)
- Italian National Institute of Health (ISS)
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- Chêne, Geneviève (author)
- University of Bordeaux
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- Pozniak, Anton (author)
- Chelsea and Westminster Hospital
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- Odermarsky, Michal (author)
- Lund University,Lunds universitet,Pediatrik, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Paediatrics (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine
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(creator_code:org_t)
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- 2014
- 2014
- English 10 s.
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In: The Lancet. - 1474-547X. ; 384:9958, s. 51-1942
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Abstract
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- BACKGROUND: Standard first-line antiretroviral therapy for HIV-1 infection includes two nucleoside or nucleotide reverse transcriptase inhibitors (NtRTIs), but these drugs have limitations. We assessed the 96 week efficacy and safety of an NtRTI-sparing regimen.METHODS: Between August, 2010, and September, 2011, we enrolled treatment-naive adults into this randomised, open-label, non-inferiority trial in treatment-naive adults in 15 European countries. The composite primary outcome was change to randomised treatment before week 32 because of insufficient virological response, no virological response by week 32, HIV-1 RNA concentration 50 copies per mL or higher at any time after week 32; death from any cause; any new or recurrent AIDS event; or any serious non-AIDS event. Patients were randomised in a 1:1 ratio to receive oral treatment with 400 mg raltegravir twice daily plus 800 mg darunavir and 100 mg ritonavir once daily (NtRTI-sparing regimen) or tenofovir-emtricitabine in a 245 mg and 200 mg fixed-dose combination once daily, plus 800 mg darunavir and 100 mg ritonavir once daily (standard regimen). This trial was registered with ClinicalTrials.gov, number NCT01066962.FINDINGS: Of 805 patients enrolled, 401 received the NtRTI-sparing regimen and 404 the standard regimen, with median follow-up of 123 weeks (IQR 112-133). Treatment failure was seen in 77 (19%) in the NtRTI-sparing group and 61 (15%) in the standard group. Kaplan-Meier estimated proportions of treatment failure by week 96 were 17·8% and 13·8%, respectively (difference 4·0%, 95% CI -0·8 to 8·8). The frequency of serious or treatment-modifying adverse events were similar (10·2 vs 8·3 per 100 person-years and 3·9 vs 4·2 per 100 person-years, respectively).INTERPRETATION: Our NtRTI-sparing regimen was non-inferior to standard treatment and represents a treatment option for patients with CD4 cell counts higher than 200 cells per μL.FUNDING: European Union Sixth Framework Programme, Inserm-ANRS, Gilead Sciences, Janssen Pharmaceuticals, Merck Laboratories.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
Keyword
- Adenine
- Adult
- Anti-HIV Agents
- CD4 Lymphocyte Count
- Cholesterol, HDL
- Cholesterol, LDL
- Darunavir
- Deoxycytidine
- Drug Resistance, Viral
- Drug Therapy, Combination
- Emtricitabine
- Female
- HIV Infections
- HIV-1
- Humans
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Organophosphonates
- Pyrrolidinones
- Raltegravir Potassium
- Ritonavir
- Sulfonamides
- Tenofovir
- Treatment Outcome
- Comparative Study
- Journal Article
- Multicenter Study
- Randomized Controlled Trial
- Research Support, Non-U.S. Gov't
Publication and Content Type
- art (subject category)
- ref (subject category)
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Raffi, François
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Babiker, Abdel G ...
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Richert, Laura
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Molina, Jean-Mic ...
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George, Elizabet ...
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Antinori, Andrea
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show more...
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Arribas, Jose R
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Grarup, Jesper
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Hudson, Fleur
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Schwimmer, Chris ...
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Saillard, Juliet ...
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Wallet, Cédrick
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Jansson, Per O.
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Allavena, Clotil ...
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Van Leeuwen, Rem ...
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Delfraissy, Jean ...
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Vella, Stefano
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Chêne, Geneviève
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Pozniak, Anton
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Odermarsky, Mich ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Infectious Medic ...
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The Lancet
- By the university
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Lund University
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Karolinska Institutet