التفاصيل البيبلوغرافية
| العنوان: |
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. |
| المؤلفون: |
Raffi, François1 francois.raffi@wanadoo.fr, Babiker, Abdel G.2, Richert, Laura3, Molina, Jean-Michel4, George, Elizabeth C.2, Antinori, Andrea5, Arribas, Jose R.6, Grarup, Jesper7, Hudson, Fleur2, Schwimmer, Christine3, Saillard, Juliette8, Wallet, Cédrick3, Jansson, Per O.7, Allavena, Clotilde1, Van Leeuwen, Remko9, Delfraissy, Jean-François10, Vella, Stefano11, Chêne, Geneviève3, Pozniak, Anton12 |
| المصدر: |
Lancet. 11/29/2014, Vol. 384 Issue 9958, p1942-1951. 10p. 1 Diagram, 4 Charts, 3 Graphs. |
| مصطلحات موضوعية: |
*RITONAVIR, *THERAPEUTICS, *HIV infections, *NUCLEOSIDES, *NUCLEOTIDES, *REVERSE transcriptase inhibitors, *DRUG efficacy |
| مستخلص: |
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% Cl -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. INSET: Systematic review. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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