| Week 96 Efficacy, Virology and Safety of Darunavir/r versus Lopinavir/r in Treatment-Experienced Patients in TITAN. | |
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MedLine Citation:
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PMID: 22339125 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Long-term potent activity of antiretrovirals is essential for HIV-1-infected, treatment-experienced patients. TITAN (TMC114/r In Treatment-experienced pAtients Naive to lopinavir) compared Week-96 efficacy and safety of darunavir/ritonavir (DRV/r) versus lopinavir/ritonavir (LPV/r). Treatment-experienced, LPV-naïve, HIV-1-infected patients were randomised to DRV/r 600/100 mg bid or LPV/r 400/100 mg bid plus optimised background regimen (≥2 NRTIs/NNRTIs). 595 patients were enrolled (mean baseline HIV-1 RNA: 4.30 log10 copies/mL; median CD4 count: 232 cells/mm3). At Week 96, more DRV/r than LPV/r patients achieved HIV-1 RNA <400 copies/mL (66.8% versus 58.9% [intent-to-treat (ITT)/time-to-loss of virological response (TLOVR)], estimated difference 8.7%, 95% confidence interval [CI]: 0.7-16.7), demonstrating the primary endpoint of non-inferiority of DRV/r (p<0.001); the difference in response was statistically significant (p=0.034). For the secondary efficacy parameter (HIV-1 RNA <50 copies/mL) at Week 96, response to DRV/r was 60.4% versus 55.2% for LPV/r (ITT-TLOVR), estimated difference 5.8%, 95% CI: -2.3-13.9. Virological failure (VF; HIV-1 RNA >400 copies/mL) with DRV/r (13.8%) was nearly half that with LPV/r (25.6%). Discontinuations due to adverse events were 8.1% for both DRV/r and LPV/r. Treatment-related grade 2-4 diarrhoea was 8.1% (DRV/r) versus 15.2% (LPV/r). Increases in triglycerides and total cholesterol were less pronounced with DRV/r. At 96 weeks, non-inferiority (HIV-1 RNA <400 copies/mL) of DRV/r over LPV/r was maintained; the difference in response was statistically significant. VF rate and treatment-related grade 2-4 diarrhoea were lower with DRV/r versus LPV/r. |
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Authors:
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Dénes Bánhegyi; Christine Katlama; Clóvis Arns da Cunha; Stefan Schneider; Anita Rachlis; Cassy Workman; Sandra De Meyer; Ann Vandevoorde; Tom Van De Casteele; Frank Tomaka |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-1-25 |
Journal Detail:
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Title: Current HIV research Volume: - ISSN: 1873-4251 ISO Abbreviation: - Publication Date: 2012 Jan |
Date Detail:
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Created Date: 2012-2-20 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101156990 Medline TA: Curr HIV Res Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Szent László Hospital, Gyali ut 5/7, Budapest, Hungary. denes.banhegyi@laszlokorhaz.hu. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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