High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial

Trial design The QoLKAMON study evaluated quality of life, efficacy and treatment safety in HIV patients receiving lopinavir/ritonavir in monotherapy (MT) versus continuing combined antiretroviral triple treatment with a boosted protease inhibitor (TT). Methods This was a 24-week, open-label, multic...

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Autores: Pasquau, Juan, Hidalgo Tenorio, Carmen, Montes, María Luisa, Romero Palacios, Alberto, Vergas, Jorge, Sanjoaquín Conde, Isabel, Hernández Quero, José, Aguirrebengoa, Koldo, Orihuela, Francisco, Imaz, Arkaitz, Ríos Villegas, María José, Flores, Juan, Fariñas, María Carmen, Vázquez, Pilar, Galindo, María José, García Mercé, Isabel, Lozano, Fernando, Santos, Ignacio de los, Jesus, Samantha Elizabeth de, García-Vallecillos, Coral, QoLKAMON STUDY GROUP
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2018
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/124025
Acceso en línea:https://hdl.handle.net/2445/124025
Access Level:acceso abierto
Palabra clave:VIH (Virus)
Antiretrovirals
HIV (Viruses)
Antiretroviral agents
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spelling High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trialPasquau, JuanHidalgo Tenorio, CarmenMontes, María LuisaRomero Palacios, AlbertoVergas, JorgeSanjoaquín Conde, IsabelHernández Quero, JoséAguirrebengoa, KoldoOrihuela, FranciscoImaz, ArkaitzRíos Villegas, María JoséFlores, JuanFariñas, María CarmenVázquez, PilarGalindo, María JoséGarcía Mercé, IsabelLozano, FernandoSantos, Ignacio de losJesus, Samantha Elizabeth deGarcía-Vallecillos, CoralQoLKAMON STUDY GROUPVIH (Virus)AntiretroviralsHIV (Viruses)Antiretroviral agentsTrial design The QoLKAMON study evaluated quality of life, efficacy and treatment safety in HIV patients receiving lopinavir/ritonavir in monotherapy (MT) versus continuing combined antiretroviral triple treatment with a boosted protease inhibitor (TT). Methods This was a 24-week, open-label, multicentre study in virologically-suppressed HIV-infected participants (N = 225) with a 2:1 randomization: 146 patients who switched to MT were compared with 79 patients who remained on a TT regimen. The primary endpoint was change in patient-reported outcomes in quality of life as measured by the MOS-HIV and EQ-5D questionnaires. Secondary endpoints included treatment adherence, patient satisfaction, incidence of adverse events and differences in plasma HIV-1 RNA viral load (VL) and CD4 cell counts. Results Baseline quality of life, measured with the MOS-HIV score, was very good (overall score of 83 +/- 10.5 in the MT arm and 82.3 +/- 11.3 in the TT arm) and suffered no change during the study in any of the arms (at week 24, 83.5 +/- 12.2 in MT arm and 81.9 +/- 12.7 in TT arm), without statistically significant differences when compared. In regards to adherence to therapy and patient satisfaction, some aspects (number of doses forgotten in the last week and satisfaction of treatment measured with the CESTA score, dimension 1) improved significantly with MT. There were also no differences in the incidence and severity of adverse events, even though 22.8% of those in the MT arm switched their treatment when they were included in the study. Moreover, there was also no significant difference between the immunological and virological evolution of MT and TT. In the MT arm, the VL was always undetectable in 83% of patients (vs 90.7% in the TT arm) and there were only 6.7% of virological failures with VL > 50 copies/mL (vs 2.3% in the TT arm), without resistance mutations and with resuppression of VL after switching back to TT. Conclusions In a new clinical trial, monotherapy as a treatment simplification strategy in HIV-1 infected patients with sustained viral suppression has demonstrated quality of life, safety and efficacy profiles comparable to those of conventional triple therapy regimens.Public Library of Science (PLoS)2018201820182018info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion15 p.application/pdfhttps://hdl.handle.net/2445/124025Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: http://dx.doi.org/10.1371/journal.pone.0195068PLoS One, 2018, vol. 13, num. 4, p. e0195068http:/dx.doi.org/10.1371/journal.pone.0195068cc by (c) Pasquau et al., 2018http://creativecommons.org/licenses/by/3.0/es/info:eu-repo/semantics/openAccessoai:recercat.cat:2445/1240252026-05-29T05:05:01Z
dc.title.none.fl_str_mv High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial
title High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial
spellingShingle High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial
Pasquau, Juan
VIH (Virus)
Antiretrovirals
HIV (Viruses)
Antiretroviral agents
title_short High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial
title_full High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial
title_fullStr High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial
title_full_unstemmed High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial
title_sort High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial
dc.creator.none.fl_str_mv Pasquau, Juan
Hidalgo Tenorio, Carmen
Montes, María Luisa
Romero Palacios, Alberto
Vergas, Jorge
Sanjoaquín Conde, Isabel
Hernández Quero, José
Aguirrebengoa, Koldo
Orihuela, Francisco
Imaz, Arkaitz
Ríos Villegas, María José
Flores, Juan
Fariñas, María Carmen
Vázquez, Pilar
Galindo, María José
García Mercé, Isabel
Lozano, Fernando
Santos, Ignacio de los
Jesus, Samantha Elizabeth de
García-Vallecillos, Coral
QoLKAMON STUDY GROUP
author Pasquau, Juan
author_facet Pasquau, Juan
Hidalgo Tenorio, Carmen
Montes, María Luisa
Romero Palacios, Alberto
Vergas, Jorge
Sanjoaquín Conde, Isabel
Hernández Quero, José
Aguirrebengoa, Koldo
Orihuela, Francisco
Imaz, Arkaitz
Ríos Villegas, María José
Flores, Juan
Fariñas, María Carmen
Vázquez, Pilar
Galindo, María José
García Mercé, Isabel
Lozano, Fernando
Santos, Ignacio de los
Jesus, Samantha Elizabeth de
García-Vallecillos, Coral
QoLKAMON STUDY GROUP
author_role author
author2 Hidalgo Tenorio, Carmen
Montes, María Luisa
Romero Palacios, Alberto
Vergas, Jorge
Sanjoaquín Conde, Isabel
Hernández Quero, José
Aguirrebengoa, Koldo
Orihuela, Francisco
Imaz, Arkaitz
Ríos Villegas, María José
Flores, Juan
Fariñas, María Carmen
Vázquez, Pilar
Galindo, María José
García Mercé, Isabel
Lozano, Fernando
Santos, Ignacio de los
Jesus, Samantha Elizabeth de
García-Vallecillos, Coral
QoLKAMON STUDY GROUP
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv VIH (Virus)
Antiretrovirals
HIV (Viruses)
Antiretroviral agents
topic VIH (Virus)
Antiretrovirals
HIV (Viruses)
Antiretroviral agents
description Trial design The QoLKAMON study evaluated quality of life, efficacy and treatment safety in HIV patients receiving lopinavir/ritonavir in monotherapy (MT) versus continuing combined antiretroviral triple treatment with a boosted protease inhibitor (TT). Methods This was a 24-week, open-label, multicentre study in virologically-suppressed HIV-infected participants (N = 225) with a 2:1 randomization: 146 patients who switched to MT were compared with 79 patients who remained on a TT regimen. The primary endpoint was change in patient-reported outcomes in quality of life as measured by the MOS-HIV and EQ-5D questionnaires. Secondary endpoints included treatment adherence, patient satisfaction, incidence of adverse events and differences in plasma HIV-1 RNA viral load (VL) and CD4 cell counts. Results Baseline quality of life, measured with the MOS-HIV score, was very good (overall score of 83 +/- 10.5 in the MT arm and 82.3 +/- 11.3 in the TT arm) and suffered no change during the study in any of the arms (at week 24, 83.5 +/- 12.2 in MT arm and 81.9 +/- 12.7 in TT arm), without statistically significant differences when compared. In regards to adherence to therapy and patient satisfaction, some aspects (number of doses forgotten in the last week and satisfaction of treatment measured with the CESTA score, dimension 1) improved significantly with MT. There were also no differences in the incidence and severity of adverse events, even though 22.8% of those in the MT arm switched their treatment when they were included in the study. Moreover, there was also no significant difference between the immunological and virological evolution of MT and TT. In the MT arm, the VL was always undetectable in 83% of patients (vs 90.7% in the TT arm) and there were only 6.7% of virological failures with VL > 50 copies/mL (vs 2.3% in the TT arm), without resistance mutations and with resuppression of VL after switching back to TT. Conclusions In a new clinical trial, monotherapy as a treatment simplification strategy in HIV-1 infected patients with sustained viral suppression has demonstrated quality of life, safety and efficacy profiles comparable to those of conventional triple therapy regimens.
publishDate 2018
dc.date.none.fl_str_mv 2018
2018
2018
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://hdl.handle.net/2445/124025
url https://hdl.handle.net/2445/124025
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: http://dx.doi.org/10.1371/journal.pone.0195068
PLoS One, 2018, vol. 13, num. 4, p. e0195068
http:/dx.doi.org/10.1371/journal.pone.0195068
dc.rights.none.fl_str_mv cc by (c) Pasquau et al., 2018
http://creativecommons.org/licenses/by/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by (c) Pasquau et al., 2018
http://creativecommons.org/licenses/by/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 15 p.
application/pdf
dc.publisher.none.fl_str_mv Public Library of Science (PLoS)
publisher.none.fl_str_mv Public Library of Science (PLoS)
dc.source.none.fl_str_mv Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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