Document Detail


96 week results from the MONET trial: a randomized comparison of darunavir/ritonavir with versus without nucleoside analogues, for patients with HIV RNA <50 copies/mL at baseline.
MedLine Citation:
PMID:  21652619     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: In virologically suppressed patients, switching to darunavir/ritonavir monotherapy could avoid resistance and adverse events from continuing nucleoside analogues.
METHODS: Two hundred and fifty-six patients with HIV RNA <50 copies/mL on current antiretrovirals were switched to darunavir/ritonavir 800/100 mg once daily, either as monotherapy (n = 127) or with two nucleoside analogues (n = 129). Treatment failure was defined as two consecutive HIV RNA levels at least 50 copies/mL by week 96, or discontinuation of study drugs. The trial had 80% power to show non-inferiority (δ = -12%) at week 48. Results Patients were 81% male, 91% Caucasian, and had a median baseline CD4 count of 575 cells/mm(3). There were more patients with hepatitis C co-infection at baseline in the monotherapy arm (18%) compared with the triple therapy arm (12%). In the efficacy analysis, HIV RNA <50 copies/mL by week 96 (per protocol, time to loss of virological response, switch equals failure) was 78% versus 82% in the monotherapy and triple therapy arms [difference -4.2%, 95% confidence interval (CI) -14.3% to +5.8%]; in a switch included analysis, HIV RNA <50 copies/mL was 93% versus 92% (difference +1.6%, 95% CI -5.0% to +8.1%). The percentage of patients with HIV RNA <5 copies/mL (optical density from the sample equal to the negative control) remained constant over time in both treatment arms. Conclusions In the week 96 analysis of the MONotherapy in Europe with TMC114 (MONET) trial, switching to darunavir/ritonavir monotherapy showed non-inferior efficacy to darunavir/ritonavir plus two nucleoside analogues in the switch included and observed failure analyses, but not in the main switch equals failure analysis.
Authors:
Nathan Clumeck; Armin Rieger; Denes Banhegyi; Wolfgang Schmidt; Andrew Hill; Yvonne Van Delft; Christiane Moecklinghoff; Jose Arribas
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2011-06-07
Journal Detail:
Title:  The Journal of antimicrobial chemotherapy     Volume:  66     ISSN:  1460-2091     ISO Abbreviation:  J. Antimicrob. Chemother.     Publication Date:  2011 Aug 
Date Detail:
Created Date:  2011-07-12     Completed Date:  2011-10-31     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  7513617     Medline TA:  J Antimicrob Chemother     Country:  England    
Other Details:
Languages:  eng     Pagination:  1878-85     Citation Subset:  IM    
Affiliation:
Hopital St Pierre, Brussels, Belgium.
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-HIV Agents / administration & dosage*
Antiretroviral Therapy, Highly Active / methods*
Europe
Female
HIV Infections / drug therapy*
Humans
Male
Nucleosides / administration & dosage*
RNA, Viral / blood
Ritonavir / administration & dosage*
Sulfonamides / administration & dosage*
Treatment Failure
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 0/Nucleosides; 0/RNA, Viral; 0/Ritonavir; 0/Sulfonamides; YO603Y8113/darunavir

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