TY - JOUR
T1 - 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
AU - Raffi, François
AU - Babiker, Abdel G.
AU - Richert, Laura
AU - Molina, Jean-Michel
AU - George, Elizabeth C.
AU - Antinori, Andrea
AU - Arribas, Jose R.
AU - Grarup, Jesper
AU - Hudson, Fleur
AU - Schwimmer, Christine
AU - Saillard, Juliette
AU - Wallet, Cédrick
AU - Jansson, Per O.
AU - Allavena, Clotilde
AU - van Leeuwen, Remko
AU - Delfraissy, Jean-François
AU - Vella, Stefano
AU - Chêne, Geneviève
AU - Pozniak, Anton
AU - AUTHOR GROUP
AU - Dedes, Nikos
AU - Autran, Brigitte
AU - Bucciardini, Raffaella
AU - Horban, Andrzej
AU - Arribas, José
AU - Boffito, Marta
AU - Pillay, Deenan
AU - Franquet, Xavier
AU - Schwarze, Siegfried
AU - Fischer, Aurélie
AU - Diallo, Alpha
AU - Moecklinghoff, Christiane
AU - Stellbrink, Hans-Jürgen
AU - Gatell, José
AU - Sandström, Eric
AU - Flepp, Markus
AU - Ewings, Fiona
AU - Pearce, Gillian
AU - Quercia, Romina
AU - Rogatto, Felipe
AU - Leavitt, Randi
AU - Nguyen, Bach-Yen
AU - Goebel, Frank
AU - Marcotullio, Simone
AU - Kaur, Navrup
AU - Sasieni, Peter
AU - Spencer-Drake, Christina
AU - Prins, Jan
AU - Wit, Ferdinand W. N. M.
AU - Reiss, Peter
AU - Nieuwkerk, Pythia
PY - 2014
Y1 - 2014
N2 - 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. 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. 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). 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. European Union Sixth Framework Programme, Inserm-ANRS, Gilead Sciences, Janssen Pharmaceuticals, Merck Laboratories
AB - 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. 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. 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). 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. European Union Sixth Framework Programme, Inserm-ANRS, Gilead Sciences, Janssen Pharmaceuticals, Merck Laboratories
U2 - https://doi.org/10.1016/S0140-6736(14)61170-3
DO - https://doi.org/10.1016/S0140-6736(14)61170-3
M3 - Article
C2 - 25103176
SN - 0140-6736
VL - 384
SP - 1942
EP - 1951
JO - Lancet
JF - Lancet
IS - 9958
ER -