Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial

Detalhes bibliográficos
Autor(a) principal: Safren, Steven A.
Data de Publicação: 2014
Outros Autores: Biello, Katie B., Smeaton, Laura, Mimiaga, Matthew J., Walawander, Ann, Lama, Javier R., Rana, Aadia, Nyirenda, Mulinda, Kayoyo, Virginia M., Samaneka, Wadzanai, Joglekar, Anjali, Celentano, David, Martinez, Ana, Remmert, Jocelyn E., Nair, Aspara, Lalloo, Umesh G., Kumarasamy, Nagalingeswaran, Hakim, James, Campbell, Thomas B., PEARLS (ACTG A5175) Study Team
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/31332
Resumo: Beatriz Grinsztejn (Fiocruz/INI) - Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta à informação no documento.
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spelling Safren, Steven A.Biello, Katie B.Smeaton, LauraMimiaga, Matthew J.Walawander, AnnLama, Javier R.Rana, AadiaNyirenda, MulindaKayoyo, Virginia M.Samaneka, WadzanaiJoglekar, AnjaliCelentano, DavidMartinez, AnaRemmert, Jocelyn E.Nair, AsparaLalloo, Umesh G.Kumarasamy, NagalingeswaranHakim, JamesCampbell, Thomas B.PEARLS (ACTG A5175) Study Team2019-01-29T12:08:53Z2019-01-29T12:08:53Z2014SAFREN, Steven A. et al. Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial. Plos One, v. 9, p. 1-10, Aug. 2014.1932-6203https://www.arca.fiocruz.br/handle/icict/3133210.1371/journal.pone.01041781932-6203Beatriz Grinsztejn (Fiocruz/INI) - Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta à informação no documento.Massachusetts General Hospital. Boston, MA, USA / Harvard Medical School. Boston, MA, USA / The Fenway Institute. Fenway Health. Boston, MA, USA.The Fenway Institute. Fenway Health. Boston, MA, USA / Harvard School of Public Health. Boston, MA, USA.Harvard School of Public Health. Boston, MA, USA.Massachusetts General Hospital. Boston, MA, USA / Harvard Medical School. Boston, MA, USA / The Fenway Institute. Fenway Health. Boston, MA, USA / Harvard School of Public Health. Boston, MA, USA.Frontier Science and Technology Research Foundation. Amherst, NY, USA.Asociación Civil Impacta Salud y Educación. Lima, Peru.Alpert Medical School. The Miriam Hospital. Providence, RI, USA.College of Medicine. Johns Hopkins Research Project. Blantyre, Malawi.University of North Carolina Project. Lilongwe, Malawi.University of Zimbabwe-University of California San Francisco Collaborative Research Program. Harare, Zimbabwe.National AIDS Research Institute. Pune, India.Johns Hopkins Bloomberg School of Public Health. Baltimore, MD, USA.NIH/NIAD/DAIDS Pharmaceutical Affairs. Bethesda, MD, USA.Massachusetts General Hospital. Boston, MA, USA.Frontier Science and Technology Research Foundation. Amherst, NY, USA.University of KwaZulu-Natal. Nelson R. Mandela School of Medicine. Durban, South Africa.YRGCARE Medical Centre. Chennai, India.University of Zimbabwe. Harare, Zimbabwe.University of Colorado Denver. Aurora, CO, USA.Background: Dolutegravir (GSK1349572), a once-daily HIV integrase inhibitor, has shown potent antiviral response and a favourable safety profi le. We evaluated safety, efficacy, and emergent resistance in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV-1 with at least two-class drug resistance. Methods: ING111762 (SAILING) is a 48 week, phase 3, randomised, double-blind, active-controlled, non-inferiority study that began in October, 2010. Eligible patients had two consecutive plasma HIV-1 RNA assessments of 400 copies per mL or higher (unless >1000 copies per mL at screening), resistance to two or more classes of antiretroviral drugs, and had one to two fully active drugs for background therapy. Participants were randomly assigned (1:1) to once-daily dolutegravir 50 mg or twice-daily raltegravir 400 mg, with investigator-selected background therapy. Matching placebo was given, and study sites were masked to treatment assignment. The primary endpoint was the proportion of patients with plasma HIV-1 RNA less than 50 copies per mL at week 48, evaluated in all participants randomly assigned to treatment groups who received at least one dose of study drug, excluding participants at one site with violations of good clinical practice. Non-inferiority was prespecified with a 12% margin; if non-inferiority was established, then superiority would be tested per a prespecified sequential testing procedure. A key prespecified secondary endpoint was the proportion of patients with treatment-emergent integrase-inhibitor resistance. The trial is registered at ClinicalTrials.gov, NCT01231516. Findings: Analysis included 715 patients (354 dolutegravir; 361 raltegravir). At week 48, 251 (71%) patients on dolutegravir had HIV-1 RNA less than 50 copies per mL versus 230 (64%) patients on raltegravir (adjusted difference 7·4%, 95% CI 0·7 to 14·2); superiority of dolutegravir versus raltegravir was then concluded (p=0·03). Significantly fewer patients had virological failure with treatment-emergent integrase-inhibitor resistance on dolutegravir (four vs 17 patients; adjusted difference –3·7%, 95% CI –6·1 to –1·2; p=0·003). Adverse event frequencies were similar across groups; the most commonly reported events for dolutegravir versus raltegravir were diarrhoea (71 [20%] vs 64 [18%] patients), upper respiratory tract infection (38 [11%] vs 29 [8%]), and headache (33 [9%] vs 31 [9%]). Safety events leading to discontinuation were infrequent in both groups (nine [3%] dolutegravir, 14 [4%] raltegravir). Interpretation: Once-daily dolutegravir, in combination with up to two other antiretroviral drugs, is well tolerated with greater virological eff ect compared with twice-daily raltegravir in this treatment-experienced patient group. Funding: ViiV Healthcare.engPublic Library of SciencePsychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleHIVAntiretroviral therapyinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83099https://www.arca.fiocruz.br/bitstream/icict/31332/1/license.txt586c046dcfeef936e32f0323bb9a47c0MD51ORIGINALve_Safren_Steven_etal_INI_2014.PDFve_Safren_Steven_etal_INI_2014.PDFapplication/pdf330745https://www.arca.fiocruz.br/bitstream/icict/31332/2/ve_Safren_Steven_etal_INI_2014.PDFf72793a514291b7de49200397556a2a7MD52TEXTve_Safren_Steven_etal_INI_2014.PDF.txtve_Safren_Steven_etal_INI_2014.PDF.txtExtracted 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dc.title.pt_BR.fl_str_mv Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial
title Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial
spellingShingle Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial
Safren, Steven A.
HIV
Antiretroviral therapy
title_short Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial
title_full Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial
title_fullStr Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial
title_full_unstemmed Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial
title_sort Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial
author Safren, Steven A.
author_facet Safren, Steven A.
Biello, Katie B.
Smeaton, Laura
Mimiaga, Matthew J.
Walawander, Ann
Lama, Javier R.
Rana, Aadia
Nyirenda, Mulinda
Kayoyo, Virginia M.
Samaneka, Wadzanai
Joglekar, Anjali
Celentano, David
Martinez, Ana
Remmert, Jocelyn E.
Nair, Aspara
Lalloo, Umesh G.
Kumarasamy, Nagalingeswaran
Hakim, James
Campbell, Thomas B.
PEARLS (ACTG A5175) Study Team
author_role author
author2 Biello, Katie B.
Smeaton, Laura
Mimiaga, Matthew J.
Walawander, Ann
Lama, Javier R.
Rana, Aadia
Nyirenda, Mulinda
Kayoyo, Virginia M.
Samaneka, Wadzanai
Joglekar, Anjali
Celentano, David
Martinez, Ana
Remmert, Jocelyn E.
Nair, Aspara
Lalloo, Umesh G.
Kumarasamy, Nagalingeswaran
Hakim, James
Campbell, Thomas B.
PEARLS (ACTG A5175) Study Team
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Safren, Steven A.
Biello, Katie B.
Smeaton, Laura
Mimiaga, Matthew J.
Walawander, Ann
Lama, Javier R.
Rana, Aadia
Nyirenda, Mulinda
Kayoyo, Virginia M.
Samaneka, Wadzanai
Joglekar, Anjali
Celentano, David
Martinez, Ana
Remmert, Jocelyn E.
Nair, Aspara
Lalloo, Umesh G.
Kumarasamy, Nagalingeswaran
Hakim, James
Campbell, Thomas B.
PEARLS (ACTG A5175) Study Team
dc.subject.en.pt_BR.fl_str_mv HIV
Antiretroviral therapy
topic HIV
Antiretroviral therapy
description Beatriz Grinsztejn (Fiocruz/INI) - Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta à informação no documento.
publishDate 2014
dc.date.issued.fl_str_mv 2014
dc.date.accessioned.fl_str_mv 2019-01-29T12:08:53Z
dc.date.available.fl_str_mv 2019-01-29T12:08:53Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv SAFREN, Steven A. et al. Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial. Plos One, v. 9, p. 1-10, Aug. 2014.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/31332
dc.identifier.issn.pt_BR.fl_str_mv 1932-6203
dc.identifier.doi.none.fl_str_mv 10.1371/journal.pone.0104178
dc.identifier.eissn.none.fl_str_mv 1932-6203
identifier_str_mv SAFREN, Steven A. et al. Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial. Plos One, v. 9, p. 1-10, Aug. 2014.
1932-6203
10.1371/journal.pone.0104178
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dc.publisher.none.fl_str_mv Public Library of Science
publisher.none.fl_str_mv Public Library of Science
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
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