Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial

Background: The NEAT001/ANRS143 trial demonstrated noninferiority of ritonavir-boosted darunavir combined with either ral-tegravir (RAL + DRV/r) or tenofovir disoproxil fumarate/ emtricitabine (TDF/FTC + DRV/r) in HIV-positive, antiretroviralnaive adults. In post hoc analyses, however, RAL + DRV/r s...

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Autores: Ammassari, A, Stohr, W, Antinori, A, Molina, JM, Schwimmer, C, Domingo, P, Thalme, A, Di Pietro, M, Wallet, C, Pozniak, A, Richert, L, Raffi, F, NEAT001 ANRS143 Trial Study Grp
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2018
País:España
Recursos:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositorio:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p3708
Acesso em linha:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=3708
https://europepmc.org/articles/pmc6250251
Access Level:acceso abierto
Palavra-chave:adherence
HIV
antiretrovirals
NtRTI-sparing regimen
raltegravir
darunavir/ritonavir
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spelling Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 TrialAmmassari, AStohr, WAntinori, AMolina, JMSchwimmer, CDomingo, PThalme, ADi Pietro, MWallet, CPozniak, ARichert, LRaffi, FNEAT001 ANRS143 Trial Study GrpadherenceHIVantiretroviralsNtRTI-sparing regimenraltegravirdarunavir/ritonavirBackground: The NEAT001/ANRS143 trial demonstrated noninferiority of ritonavir-boosted darunavir combined with either ral-tegravir (RAL + DRV/r) or tenofovir disoproxil fumarate/ emtricitabine (TDF/FTC + DRV/r) in HIV-positive, antiretroviralnaive adults. In post hoc analyses, however, RAL + DRV/r showed inferiority in patients with baseline CD4+,200/mm(3) and HIV-1 RNA $ 100,000 copies per milliliter. This preplanned ancillary study was conducted to assess whether differences in adherence might explain efficacy results. Setting: Phase III, open-label, randomized, multicenter study in 15 European countries (ClinicalTrials. gov, NCT01066962). Methods: Seven hundred seventy-four participants self-reported adherence (modified AIDS Clinical Trials Group questionnaire) over 96 weeks [383 RAL + DRV/r (twice daily; 5 pills/day), 391 TDF/FTC + DRV/r (once daily; 4 pills/day)]. Primary endpoint was $ 95% versus,95% adherence to prescribed doses recorded (1) over the last 4 days or (2) on the visual analogue scale over the last 30 days. Results: Characteristics, except age, were similar between arms; 9% had CD4+,200 cells/mm(3) and HIV-1 RNA $ 100,000 copies per milliliter. Adherence $ 95% in the last 4 days (P = 0.029) or at the visual analogue scale (P = 0.0072) was higher with TDF/FTC + DRV/r than with RAL + DRV/r. Adherence $ 95% over the last 4 days was associated with lower probability of virological failure (P = 0.015). Adherence in patients with baseline CD4+,200 cells/mm(3) and HIV-1 RNA $ 100,000 copies per milliliter was similar to the rest of the population, and not significantly associated with efficacy measures, with no significant differences between arms. Conclusion: Adherence was high and slightly better in the TDF/ FTC + DRV/r than in the RAL + DRV/r arm. No convincing evidence was found that higher failure rate in the RAL + DRV/r arm in the subgroup with worse baseline viroimmunological status is caused by adherence differences.LIPPINCOTT WILLIAMS & WILKINS2018info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=3708https://europepmc.org/articles/pmc6250251JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMESISSN: 15254135ISSNe: 10779450reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p37082026-06-14T12:41:47Z
dc.title.none.fl_str_mv Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial
title Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial
spellingShingle Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial
Ammassari, A
adherence
HIV
antiretrovirals
NtRTI-sparing regimen
raltegravir
darunavir/ritonavir
title_short Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial
title_full Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial
title_fullStr Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial
title_full_unstemmed Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial
title_sort Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial
dc.creator.none.fl_str_mv Ammassari, A
Stohr, W
Antinori, A
Molina, JM
Schwimmer, C
Domingo, P
Thalme, A
Di Pietro, M
Wallet, C
Pozniak, A
Richert, L
Raffi, F
NEAT001 ANRS143 Trial Study Grp
author Ammassari, A
author_facet Ammassari, A
Stohr, W
Antinori, A
Molina, JM
Schwimmer, C
Domingo, P
Thalme, A
Di Pietro, M
Wallet, C
Pozniak, A
Richert, L
Raffi, F
NEAT001 ANRS143 Trial Study Grp
author_role author
author2 Stohr, W
Antinori, A
Molina, JM
Schwimmer, C
Domingo, P
Thalme, A
Di Pietro, M
Wallet, C
Pozniak, A
Richert, L
Raffi, F
NEAT001 ANRS143 Trial Study Grp
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv adherence
HIV
antiretrovirals
NtRTI-sparing regimen
raltegravir
darunavir/ritonavir
topic adherence
HIV
antiretrovirals
NtRTI-sparing regimen
raltegravir
darunavir/ritonavir
description Background: The NEAT001/ANRS143 trial demonstrated noninferiority of ritonavir-boosted darunavir combined with either ral-tegravir (RAL + DRV/r) or tenofovir disoproxil fumarate/ emtricitabine (TDF/FTC + DRV/r) in HIV-positive, antiretroviralnaive adults. In post hoc analyses, however, RAL + DRV/r showed inferiority in patients with baseline CD4+,200/mm(3) and HIV-1 RNA $ 100,000 copies per milliliter. This preplanned ancillary study was conducted to assess whether differences in adherence might explain efficacy results. Setting: Phase III, open-label, randomized, multicenter study in 15 European countries (ClinicalTrials. gov, NCT01066962). Methods: Seven hundred seventy-four participants self-reported adherence (modified AIDS Clinical Trials Group questionnaire) over 96 weeks [383 RAL + DRV/r (twice daily; 5 pills/day), 391 TDF/FTC + DRV/r (once daily; 4 pills/day)]. Primary endpoint was $ 95% versus,95% adherence to prescribed doses recorded (1) over the last 4 days or (2) on the visual analogue scale over the last 30 days. Results: Characteristics, except age, were similar between arms; 9% had CD4+,200 cells/mm(3) and HIV-1 RNA $ 100,000 copies per milliliter. Adherence $ 95% in the last 4 days (P = 0.029) or at the visual analogue scale (P = 0.0072) was higher with TDF/FTC + DRV/r than with RAL + DRV/r. Adherence $ 95% over the last 4 days was associated with lower probability of virological failure (P = 0.015). Adherence in patients with baseline CD4+,200 cells/mm(3) and HIV-1 RNA $ 100,000 copies per milliliter was similar to the rest of the population, and not significantly associated with efficacy measures, with no significant differences between arms. Conclusion: Adherence was high and slightly better in the TDF/ FTC + DRV/r than in the RAL + DRV/r arm. No convincing evidence was found that higher failure rate in the RAL + DRV/r arm in the subgroup with worse baseline viroimmunological status is caused by adherence differences.
publishDate 2018
dc.date.none.fl_str_mv 2018
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=3708
https://europepmc.org/articles/pmc6250251
url https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=3708
https://europepmc.org/articles/pmc6250251
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv LIPPINCOTT WILLIAMS & WILKINS
publisher.none.fl_str_mv LIPPINCOTT WILLIAMS & WILKINS
dc.source.none.fl_str_mv JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
ISSN: 15254135
ISSNe: 10779450
reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
instname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
instname_str Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
reponame_str r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
collection r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
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repository.mail.fl_str_mv
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