Document Detail


Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials.
MedLine Citation:
PMID:  17416261     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The continuing, randomised, multinational, phase IIB POWER 1 and 2 studies aim to evaluate efficacy and safety of darunavir in combination with low-dose ritonavir in treatment-experienced HIV-1-infected patients. We did a pooled subgroup analysis to update results at week 48 for patients receiving the recommended dose of darunavir-ritonavir compared with those receiving other protease inhibitors (PIs).
METHODS: After 24-week dose-finding phases and primary efficacy analyses, patients randomised to receive darunavir-ritonavir were given 600/100 mg twice daily, and patients receiving control PIs continued on assigned treatment into the longer-term, open-label phase; all patients continued on optimised background regimen. We assessed patients who had reached week 48 or discontinued earlier at the time of analysis; for the darunavir-ritonavir group, only patients who received 600/100 mg twice daily from baseline were included. Analyses were intention-to-treat. The POWER 2 study (TMC114-C202) is registered with ClinicalTrials.gov (NCT00071097).
FINDINGS: At week 48, 67 of 110 (61%) darunavir-ritonavir patients compared with 18 of 120 (15%) of control PI patients had viral load reductions of 1 log10 copies per mL or greater from baseline (primary endpoint; difference in response rates 46%, 95% CI 35%-57%, p<0.0001). Based on a logistic regression model including stratification factors (baseline number of primary PI mutations, use of enfuvirtide, baseline viral load) and study as covariates, the difference in response was 50% (odds ratio 11.72, 95% CI 5.75-23.89). In the darunavir-ritonavir group, rates of adverse events were mostly lower than or similar to those in the control group when corrected for treatment exposure. No unexpected safety concerns were identified.
INTERPRETATION: Efficacy responses with darunavir-ritonavir 600/100 mg twice daily plus optimised background regimen were greater than those with control PI and were sustained to at least week 48, with favourable safety and tolerability in treatment-experienced patients. This regimen could expand the treatment options available for such patients.
Authors:
Bonaventura Clotet; Nicholas Bellos; Jean-Michel Molina; David Cooper; Jean-Christophe Goffard; Adriano Lazzarin; Andrej Wöhrmann; Christine Katlama; Timothy Wilkin; Richard Haubrich; Calvin Cohen; Charles Farthing; Dushyantha Jayaweera; Martin Markowitz; Peter Ruane; Sabrina Spinosa-Guzman; Eric Lefebvre;
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Lancet     Volume:  369     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2007 Apr 
Date Detail:
Created Date:  2007-04-09     Completed Date:  2007-04-19     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  1169-78     Citation Subset:  AIM; IM    
Affiliation:
Hospital Universitari Germans Trias i Pujol and irsiCaixa Foundation, Ctra de Canyet s/n 08916, Barcelona, Catalonia, Spain. bclotet@irsicaixa.es
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00071097
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MeSH Terms
Descriptor/Qualifier:
Adult
Drug Administration Schedule
Drug Therapy, Combination
Female
HIV Infections / drug therapy*
HIV Protease Inhibitors / administration & dosage,  adverse effects,  therapeutic use*
HIV-1*
Humans
Male
Middle Aged
RNA, Viral / blood*,  drug effects
Ritonavir / administration & dosage,  adverse effects,  therapeutic use*
Sulfonamides / administration & dosage,  adverse effects,  therapeutic use*
Viral Load
Chemical
Reg. No./Substance:
0/HIV Protease Inhibitors; 0/RNA, Viral; 0/Ritonavir; 0/Sulfonamides; YO603Y8113/darunavir
Comments/Corrections
Comment In:
Lancet. 2007 Apr 7;369(9568):1143-4   [PMID:  17416241 ]
Erratum In:
Lancet. 2008 Jan 12;371(9607):116

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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