Subgroup analysis of virological response rates with once- and twice-daily darunavir/ritonavir in treatment-experienced patients without darunavir resistance-associated mutations in the ODIN trial.

Abstract:

BACKGROUND:ODIN (once-daily darunavir in treatment-experienced patients) was a 48-week, phase III, randomized, open-label trial comparing once-daily (qd) darunavir/ritonavir (DRV/r) 800/100 mg with twice-daily (bid) DRV/r 600/100 mg, both with an optimized background regimen [OBR; at least two nucleoside reverse transcriptase inhibitors (NRTIs)], in treatment-experienced, HIV-1-infected adults with no DRV resistance-associated mutations (RAMs) at screening. Week 48 analyses of virological response by subgroups are reported. METHODS:A total of 590 patients were randomized to receive qd (n=294) or bid (n=296) DRV/r. Virological response (HIV-1 RNA <50 copies/mL) was assessed according to: screening HIV-1 RNA (≥ or <50000 copies/mL), CD4 cell count, prior protease inhibitor (PI) use, number of active NRTIs in the OBR, presence of mutations (primary PI mutations, PI RAMs or M184V/I), gender, age, race, HIV-1 clade and adherence. RESULTS:Baseline characteristics were well balanced between arms and across subgroups. Response rates were comparable between qd and bid DRV/r treatments for all subgroups examined. Response rates were 78.4 and 76.8% in the qd and bid treatment arms, respectively, in patients with baseline HIV-1 RNA ≤ 50000 copies/mL and 52.8% in both arms in those with > 50000 copies/mL. Response rates for the qd and bid treatment arms by baseline CD4 cell count were also similar (69.6 vs. 65.2% for <200 cells/μL; 72.2 vs. 74.8% for 200- <350 cells/μL; 77.0 vs. 74.3% for ≥ 350 cells/μL). CONCLUSIONS:DRV/r administered either qd or bid provided effective treatment for antiretroviral treatment-experienced patients with no DRV RAMs, with comparable response rates across all subgroups studied. Low patient numbers in specific subgroups may limit interpretation of these specific subgroup results.

journal_name

HIV Med

journal_title

HIV medicine

authors

Sension M,Cahn P,Domingo P,Hodder S,Opsomer M,Lathouwers E,Van de Casteele T,Tomaka F

doi

10.1111/hiv.12024

subject

Has Abstract

pub_date

2013-08-01 00:00:00

pages

437-44

issue

7

eissn

1464-2662

issn

1468-1293

journal_volume

14

pub_type

杂志文章,随机对照试验
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    pub_type: 临床试验,杂志文章,多中心研究

    doi:10.1111/j.1468-1293.2007.00464.x

    authors: Mallolas J,Blanco J,Labarga P,Vergara A,Ocampo A,Sarasa M,Arnedo M,López-Púa Y,García J,Juega J,Guelar A,Terrón A,Dalmau D,García I,Zárraga M,Martínez E,Carné X,Pumarola T,Escayola R,Gatell J

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    authors: Bogorodskaya M,Lyass A,Mahoney TF,Borowsky LH,Sen P,Swirski FK,Srinivasa S,Longenecker CT,Massaro JM,D'Agostino RB Sr,Triant VA

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    pub_type: 杂志文章

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    authors: González R,Munguambe K,Aponte J,Bavo C,Nhalungo D,Macete E,Alonso P,Menéndez C,Naniche D

    更新日期:2012-11-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1111/hiv.12196

    authors: Malkina A,Scherzer R,Shlipak MG,Bacchetti P,Tien PC,Grunfeld C,Kosmiski L,Peralta CA

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    pub_type: 杂志文章

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    更新日期:2002-07-01 00:00:00

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    pub_type: 杂志文章

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    journal_title:HIV medicine

    pub_type: 杂志文章,多中心研究

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    更新日期:2010-10-01 00:00:00

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    pub_type: 杂志文章

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    更新日期:2015-10-01 00:00:00

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    pub_type: 杂志文章,多中心研究

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    更新日期:2009-03-01 00:00:00

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    pub_type: 杂志文章,评审

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    authors: Antela A,Aguiar C,Compston J,Hendry BM,Boffito M,Mallon P,Pourcher-Martinez V,Di Perri G

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    pub_type: 杂志文章

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    authors: Andraghetti R,Foran S,Colebunders R,Tomlinson D,Vyras P,Borleffs CJ,Fleerackers Y,Schrooten W,Borchert M

    更新日期:2001-01-01 00:00:00

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    pub_type: 杂志文章,多中心研究

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    更新日期:2009-05-01 00:00:00

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    pub_type: 杂志文章

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    authors: Tung MY,Mandalia S,Bower M,Gazzard B,Nelson M

    更新日期:2005-05-01 00:00:00

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    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/j.1468-1293.2009.00718.x

    authors: Powers V,Ward J,Gompels M

    更新日期:2009-09-01 00:00:00

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    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/hiv.12646

    authors: Acosta MC,Kundro M,Viloria G,Peressín Paz A,Morello F,Latorre F,Seoane E,Toibaro J,Losso M

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    pub_type: 杂志文章

    doi:10.1111/hiv.12431

    authors: Gisslén M,Svedhem V,Lindborg L,Flamholc L,Norrgren H,Wendahl S,Axelsson M,Sönnerborg A

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    pub_type: 杂志文章,评审

    doi:10.1046/j.1468-1293.2000.00027.x

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    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/hiv.12809

    authors: Desai S,Tavoschi L,Sullivan AK,Combs L,Raben D,Delpech V,Jakobsen SF,Amato-Gauci AJ,Croxford S

    更新日期:2020-03-01 00:00:00

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    journal_title:HIV medicine

    pub_type: 杂志文章,随机对照试验

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    authors: Menezes CN,Crowther NJ,Duarte R,Van Amsterdam D,Evans D,Dickens C,Dix-Peek T,Rassool M,Prinsloo A,Raal F,Sanne I

    更新日期:2014-01-01 00:00:00

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    journal_title:HIV medicine

    pub_type: 杂志文章

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    authors: Wilmer A,Romney MG,Gustafson R,Sandhu J,Chu T,Ng C,Hoang L,Champagne S,Hull MW

    更新日期:2015-03-01 00:00:00

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    journal_title:HIV medicine

    pub_type: 临床试验,杂志文章,多中心研究

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    更新日期:2007-04-01 00:00:00

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    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/j.1468-1293.2006.00386.x

    authors: Marazzi MC,Germano P,Liotta G,Guidotti G,Loureiro S,da Cruz Gomes A,Valls Blazquez MC,Narciso P,Perno CF,Mancinelli S,Palombi L

    更新日期:2006-07-01 00:00:00

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    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/j.1468-1293.2008.00523.x

    authors: Cozzi-Lepri A,Standardization and Clinical Relevance of HIV Drug Resistance Testing Project for the Forum for Collaborative HIV Research.

    更新日期:2008-01-01 00:00:00

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    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/j.1468-1293.2008.00577.x

    authors: Crum-Cianflone N,Weekes J,Bavaro M

    更新日期:2008-07-01 00:00:00

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    journal_title:HIV medicine

    pub_type: 杂志文章,评审

    doi:10.1111/hiv.13022

    authors: Lin L,Li TS

    更新日期:2020-12-01 00:00:00

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    journal_title:HIV medicine

    pub_type: 杂志文章,多中心研究

    doi:10.1111/j.1468-1293.2009.00762.x

    authors: Orkin C,Sadiq ST,Rice L,Jackson F,UK EPI team.

    更新日期:2010-03-01 00:00:00

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    journal_title:HIV medicine

    pub_type: 杂志文章,随机对照试验

    doi:10.1111/hiv.12240

    authors: Kunisaki KM,Niewoehner DE,Collins G,Nixon DE,Tedaldi E,Akolo C,Kityo C,Klinker H,La Rosa A,Connett JE,International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group.

    更新日期:2015-04-01 00:00:00

  • RNA amplification of the HIV-1 Pol and env regions on dried serum and plasma spots.

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    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/j.1468-1293.2008.00604.x

    authors: Dachraoui R,Brand D,Brunet S,Barin F,Plantier JC

    更新日期:2008-08-01 00:00:00

  • Lopinavir and atazanavir in pregnancy: comparable infant outcomes, virological efficacies and preterm delivery rates.

    abstract:OBJECTIVES:The aim of the study was to identify differences in infant outcomes, virological efficacy, and preterm delivery (PTD) outcome between women exposed to lopinavir/ritonavir (LPV/r) and those exposed to atazanavir/ritonavir (ATV/r). METHODS:A retrospective case note review was carried out. The case notes of 49...

    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/hiv.12277

    authors: Perry ME,Taylor GP,Sabin CA,Conway K,Flanagan S,Dwyer E,Stevenson J,Mulka L,McKendry A,Williams E,Barbour A,Dermont S,Roedling S,Shah R,Anderson J,Rodgers M,Wood C,Sarner L,Hay P,Hawkins D,deRuiter A

    更新日期:2016-01-01 00:00:00

  • Blood Epstein-Barr virus DNA load and risk of progression to AIDS-related systemic B lymphoma.

    abstract:BACKGROUND:AIDS-related lymphoma (ARL) remains the main cause of AIDS-related deaths in the combined antiretroviral therapy (cART) era. Although most ARLs are associated with the Epstein-Barr virus (EBV), whether patients with high EBV burden are more at risk of developing ARL is unknown. This study investigated the re...

    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/j.1468-1293.2012.00998.x

    authors: Leruez-Ville M,Seng R,Morand P,Boufassa F,Boue F,Deveau C,Rouzioux C,Goujard C,Seigneurin JM,Meyer L

    更新日期:2012-09-01 00:00:00