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Lancet. 2014 Nov 29;384(9958):1942-51. doi: 10.1016/S0140-6736(14)61170-3. Epub 2014 Aug 4.

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.

Collaborators (267)

Dedes N, Chêne G, Richert L, Allavena C, Raffi F, Autran B, Antinori A, Bucciardini R, Vella S, Horban A, Arribas J, Babiker AG, Boffito M, Pillay D, Pozniak A, Franquet X, Schwarze S, Grarup J, Chêne G, Fischer A, Richert L, Wallet C, Raffi F, Diallo A, Molina JM, Saillard J, Moecklinghoff C, Stellbrink HJ, Vella S, Van Leeuwen R, Gatell J, Sandström E, Flepp M, Babiker AG, Ewings F, George EC, Hudson F, Pozniak A, Pearce G, Quercia R, Rogatto F, Leavitt R, Nguyen BY, Goebel F, Marcotullio S, Kaur N, Sasieni P, Spencer-Drake C, Peto T, Miller V, Allavena C, Raffi F, Vella S, Pozniak A, Chêne G, Arnault F, Boucherie C, Fischer A, Jean D, Paniego V, Paraina F, Richert L, Rouch E, Schwimmer C, Soussi M, Taieb A, Touzeau G, Wallet C, Babiker AG, Cursley A, Dodds W, Ewings F, George EC, Hoppe A, Hudson F, Kummeling I, Pacciarini F, Paton N, Russell C, Taylor K, Ward D, Aagaard B, Eid M, Gey D, Jensen BG, Grarup J, Jakobsen ML, Jansson PO, Jensen K, Joensen ZM, Larsen EM, Pahl C, Pearson M, Nielsen BR, Reilev SS, Christ I, Lathouwers D, Manting C, Van Leeuwen R, Diallo A, Mendy BY, Metro A, Saillard J, Couffin-Cadiergues S, Knellwolf AL, Palmisano L, Aznar E, Barea C, Cotarelo M, Esteban H, Girbau I, Moyano B, Ramirez M, Saiz C, Sanchez I, Yllescas M, Binelli A, Colasanti V, Massella M, Palmisano L, Anagnostou O, Gioukari V, Touloumi G, Schmied B, Rieger A, Vetter N, De Wit S, Florence E, Vandekerckhove L, Gerstoft J, Mathiesen L, Katlama C, Cabie A, Cheret A, Dupon M, Ghosn J, Girard PM, Goujard C, Lévy Y, Molina JM, Morlat P, Neau D, Obadia M, Perre P, Piroth L, Reynes J, Tattevin P, Raffi F, Ragnaud JM, Weiss L, Yazdanpanah Y, Yeni P, Zucman D, Behrens G, Esser S, Fätkenheuer G, Hoffmann C, Jessen H, Rockstroh J, Schmidt R, Stephan C, Unger S, Hatzakis A, Daikos GL, Papadopoulos A, Skoutelis A, Banhegyi D, Mallon P, Mulcahy F, Antinori A, Andreoni M, Bonora S, Castelli F, Monforte AD, Galli M, Lazzarin A, Mazzotta F, Vullo V, Prins J, Richter C, Verhagen D, Eeden V, Horban A, Doroana M, Antunes F, Maltez F, Sarmento-Castro R, Gonzalez Garcia J, López Aldeguer J, Clotet B, Domingo P, Gatell JM, Knobel H, Marquez M, Pilar Miralles M, Portilla J, Soriano V, Tellez MJ, Thalme A, Blaxhult A, Gisslen M, Winston A, Fox J, Gompels M, Herieka E, Johnson M, Leen C, Pozniak A, Teague A, Williams I, Boyd MA, Grarup J, Jansson PO, Møller NF, Larsen EF, Morlat P, Piroth L, Le Moing V, Wit FW, Kowalska J, Berenguer J, Moreno S, Müller NJ, Török E, Post F, Angus B, Pillay D, Boucher C, Calvez V, Collins S, Dunn D, Fox Z, Perno CF, Boffito M, Ammassari A, Antinori A, Stoehr W, Autran B, Schmidt RE, Odermarsky M, Smith C, Thiébaut R, Arribas J, De La Serna JI, Castagna A, De Wit S, Franquet X, Furrer HJ, Katlama C, Mocroft A, Reiss P, Bucciardini R, Dedes N, Fragola V, George EC, Lauriola M, Murri R, Nieuwkerk P, Spire B, Volny-Anne A, West B, Amieva H, Antinori A, Llibre Codina JM, Richert L, Stoehr W, Winston A.

Author information

1
Infectious Diseases Department, University of Nantes, Nantes, France. Electronic address: francois.raffi@wanadoo.fr.
2
MRC Clinical Trials Unit at University College London, London, UK.
3
Inserm U897 Epidemiologie-Biostatistique, University of Bordeaux, Bordeaux, France.
4
Department of Infectious Diseases, Saint-Louis Hospital, Assistance Publique Hôpitaux de Paris and University of Paris Diderot, Paris, France.
5
Clinical Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy.
6
HIV Unit, Internal Medicine Service, Hospital La Paz, Madrid, Spain.
7
CHIP Department of Infectious Diseases and Rheumatology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
8
ANRS, Paris, France.
9
Infectious Diseases Department, University of Nantes, Nantes, France.
10
Academic Medical Centre, Amsterdam Institute for Global Health and Development, Amsterdam, Netherlands.
11
Service de Médecine Interne - Immunologie Clinique, ANRS, CHU de Bicêtre, Paris France.
12
Istituto Superiore di Sanità, Rome, Italy.
13
Chelsea and Westminster NHS Foundation Trust, London, UK.

Abstract

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.

PMID:
25103176
DOI:
10.1016/S0140-6736(14)61170-3
[Indexed for MEDLINE]

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