Document Detail

Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis.
MedLine Citation:
PMID:  19487905     Owner:  NLM     Status:  MEDLINE    
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.
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:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  AIDS (London, England)     Volume:  23     ISSN:  1473-5571     ISO Abbreviation:  AIDS     Publication Date:  2009 Aug 
Date Detail:
Created Date:  2009-08-17     Completed Date:  2009-12-14     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  8710219     Medline TA:  AIDS     Country:  England    
Other Details:
Languages:  eng     Pagination:  1679-88     Citation Subset:  IM; X    
Private Practice, Los Angeles, USA.
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MeSH Terms
Antiretroviral Therapy, Highly Active / adverse effects,  methods
CD4 Lymphocyte Count
Drug Administration Schedule
Drug Resistance, Multiple, Viral
HIV Infections / drug therapy*,  immunology,  virology
HIV Protease Inhibitors / administration & dosage,  adverse effects,  therapeutic use*
HIV-1 / drug effects*,  isolation & purification
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
Reg. No./Substance:
0/HIV Protease Inhibitors; 0/Lopinavir; 0/Pyrimidinones; 0/RNA, Viral; 0/Ritonavir; 0/Sulfonamides; YO603Y8113/darunavir

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