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...
| Autores: | , , , , , , , , , , , , , , , , , , , , |
|---|---|
| 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 |
| id |
ES_4eec6ec92b65f866ca5785d2e569f3af |
|---|---|
| oai_identifier_str |
oai:recercat.cat:2445/124025 |
| network_acronym_str |
ES |
| network_name_str |
España |
| spelling |
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 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 VIH (Virus) Antiretrovirals HIV (Viruses) Antiretroviral agents 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. Public Library of Science (PLoS) https://hdl.handle.net/2445/124025 |
| 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 |
| 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 |
| topic |
VIH (Virus) Antiretrovirals HIV (Viruses) Antiretroviral agents |
| topic_facet |
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 |
| format |
article |
| status_str |
publishedVersion |
| url |
https://hdl.handle.net/2445/124025 |
| eu_rights_str_mv |
openAccess |
| publisher |
Public Library of Science (PLoS) |
| institution |
Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| collection |
Recercat. Dipósit de la Recerca de Catalunya |
| reponame_str |
Recercat. Dipósit de la Recerca de Catalunya |
| instname_str |
Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| _version_ |
1878434473184329728 |
| publishDateSort |
2018 |
| author_browse |
Aguirrebengoa, Koldo Fariñas, María Carmen Flores, Juan Galindo, María José García Mercé, Isabel García-Vallecillos, Coral Hernández Quero, José Hidalgo Tenorio, Carmen Imaz, Arkaitz Jesus, Samantha Elizabeth de Lozano, Fernando Montes, María Luisa Orihuela, Francisco Pasquau, Juan QoLKAMON STUDY GROUP Romero Palacios, Alberto Ríos Villegas, María José Sanjoaquín Conde, Isabel Santos, Ignacio de los Vergas, Jorge Vázquez, Pilar |
| publisherStr |
Public Library of Science (PLoS) |
| score |
6,9303427 |