| Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis. | |
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MedLine Citation:
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PMID: 19487905 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: Present 96-week data from ongoing ARTEMIS (AntiRetroviral Therapy with TMC114 ExaMined In Naive Subjects) trial. METHODS: Randomized, open-label, phase III trial of antiretroviral-naive patients with HIV-1 RNA at least 5000 copies/ml (stratified by HIV-1 RNA and CD4 cell count) receiving darunavir/ritonavir (DRV/r) 800/100 mg once daily or lopinavir/ritonavir (LPV/r) 800/200 mg total daily dose (twice daily or once daily) and fixed-dose tenofovir/emtricitabine. Primary outcome measure was noninferiority of DRV/r vs. LPV/r in virologic response (<50 copies/ml, time-to-loss of virologic response) at 96 weeks (secondary outcome: superiority). RESULTS: Six hundred eighty-nine patients were enrolled. At week 96, significantly more DRV/r (79%) than LPV/r patients (71%) had viral load less than 50 copies/ml, confirming statistical noninferiority (estimated difference: 8.4%; 95% confidence interval 1.9-14.8; P < 0.001; per-protocol) and superiority (P = 0.012; intent-to-treat) in virologic response. Median CD4 cell count increases from baseline were 171 and 188 cells/microl for DRV/r and LPV/r, respectively (P = 0.57; noncompleter=failure). Overall, 4% of DRV/r patients and 9% of LPV/r patients discontinued treatment due to adverse events. Lower rates of grade 2-4 treatment-related diarrhea were seen with DRV/r (4%) vs. LPV/r (11%; P < 0.001), whereas grade 2-4 treatment-related rash occurred infrequently in both arms (3 vs. 1%, respectively; P = 0.273). DRV/r patients had smaller median increases in triglycerides (0.1 and 0.6 mmol/l, respectively, P < 0.0001) and total cholesterol (0.6 and 0.9 mmol/l, respectively; P < 0.0001) than LPV/r patients; levels remained below National Cholesterol Education Program cut-offs for DRV/r. CONCLUSION: At week 96, once-daily DRV/r was both statistically noninferior and superior in virologic response to LPV/r, with a more favorable gastrointestinal and lipid profile, confirming DRV/r as an effective, well tolerated, and durable option for antiretroviral-naive patients. |
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Authors:
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Anthony M Mills; Mark Nelson; Dushyantha Jayaweera; Kiat Ruxrungtham; Isabel Cassetti; Pierre-Marie Girard; Cassy Workman; Inge Dierynck; Vanitha Sekar; Carline Vanden Abeele; Ludo Lavreys |
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Publication Detail:
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Type: Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: AIDS (London, England) Volume: 23 ISSN: 1473-5571 ISO Abbreviation: AIDS Publication Date: 2009 Aug |
Date Detail:
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Created Date: 2009-08-17 Completed Date: 2009-12-14 Revised Date: 2013-06-03 |
Medline Journal Info:
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Nlm Unique ID: 8710219 Medline TA: AIDS Country: England |
Other Details:
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Languages: eng Pagination: 1679-88 Citation Subset: IM; X |
Affiliation:
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Private Practice, Los Angeles, USA. tmills@tonymillsmd.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Antiretroviral Therapy, Highly Active / adverse effects, methods CD4 Lymphocyte Count Drug Administration Schedule Drug Resistance, Multiple, Viral Female HIV Infections / drug therapy*, immunology, virology HIV Protease Inhibitors / administration & dosage, adverse effects, therapeutic use* HIV-1 / drug effects*, isolation & purification Humans Lopinavir Male Middle Aged Pyrimidinones / administration & dosage, adverse effects, therapeutic use RNA, Viral / blood Ritonavir / administration & dosage, adverse effects, therapeutic use Sulfonamides / administration & dosage, adverse effects, therapeutic use Treatment Outcome Viral Load |
| Chemical | |
Reg. No./Substance:
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0/HIV Protease Inhibitors; 0/Lopinavir; 0/Pyrimidinones; 0/RNA, Viral; 0/Ritonavir; 0/Sulfonamides; YO603Y8113/darunavir |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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