Efficacy and safety of ritonavir dose reduction based on the tipranavir inhibitory quotient in HIV-infected patients on salvage antiretroviral therapy with tipranavir/ritonavir

Ritonavir-related adverse events have been reported in patients taking tipranavir/ritonavir at the licensed dosage of 500/200 mg twice daily (bid). The aim of this open-label, prospective, single-arm pilot study was to evaluate the efficacy and safety of a ritonavir dose reduction to 100 mg bid guid...

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Autores: Moltó, José, Valle, Marta, Santos, José Ramón, Miranda, Cristina, Cedeño, Samandhy, Negredo, Eugènia, Yritia, Mercedes, Videla, Sebastià, Clotet, Bonaventura, 1953-
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2010
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:2445/179638
Acceso en línea:https://hdl.handle.net/2445/179638
Access Level:acceso abierto
Palabra clave:VIH (Virus)
Administració de medicaments
Efectes secundaris dels medicaments
HIV (Viruses)
Administration of drugs
Drug side effects
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spelling Efficacy and safety of ritonavir dose reduction based on the tipranavir inhibitory quotient in HIV-infected patients on salvage antiretroviral therapy with tipranavir/ritonavirMoltó, JoséValle, MartaSantos, José RamónMiranda, CristinaCedeño, SamandhyNegredo, EugèniaYritia, MercedesVidela, SebastiàClotet, Bonaventura, 1953-VIH (Virus)Administració de medicamentsEfectes secundaris dels medicamentsHIV (Viruses)Administration of drugsDrug side effectsRitonavir-related adverse events have been reported in patients taking tipranavir/ritonavir at the licensed dosage of 500/200 mg twice daily (bid). The aim of this open-label, prospective, single-arm pilot study was to evaluate the efficacy and safety of a ritonavir dose reduction to 100 mg bid guided by the tipranavir virtual inhibitory quotient (vIQ) in HIV-infected patients receiving tipranavir/ritonavir 500/200 mg bid whose viral load was <50 copies/ml and whose tipranavir vIQ was >60. Viral load, blood chemistry, and tipranavir and ritonavir trough concentrations (C(trough)) in plasma were determined at baseline and up to 48 weeks. If the tipranavir vIQ fell to <40, the ritonavir dose was increased to 200 mg bid. The primary endpoint was the percentage of treatment failure after 48 weeks. Eleven patients were enrolled. At baseline, the median (IQR) CD4+ T-cell count and vIQ were 380 (231-520) cells/mm(3) and 233.4 (73.8-584.8), respectively. Ten patients (90.9%) maintained a viral load <50 copies/ml at week 48. Geometric mean (95% confidence interval) tipranavir C(trough) decreased from 24.7 (12.9-47.5) mg/l at baseline to 13.6 (7.1-26.2) mg/l at week 48 (p = 0.194), but the ritonavir dose had to be raised in only one patient. Median triglycerides and ALT concentrations decreased from 177.2 (132.9-292.4) mg/dl and 59 (23-128) IU/l at baseline to 158.0 (131.0-186.0) mg/dl and 28 (20-71) IU/l at week 48 (p = 0.047, p = 0.041), respectively. As a conclusion, ritonavir-dose reduction to 100 mg bid as a treatment-simplification strategy guided by the tipranavir vIQ in patients receiving salvage therapy with tipranavir/ritonavir 500/200 mg bid seems to be safe enough to be tested in adequately powered clinical trials.Mary Ann Liebert2021202120102021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion6 p.application/pdfhttps://hdl.handle.net/2445/179638Articles publicats en revistes (Patologia i Terapèutica Experimental)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: https://doi.org/10.1089/aid.2009.0304Aids Research and Human Retroviruses, 2010, vol. 26, num. 11, p. 1191-1196https://doi.org/10.1089/aid.2009.0304info:eu-repo/grantAgreement/EC/FP7/223131(c) Mary Ann Liebert, 2010info:eu-repo/semantics/openAccessoai:recercat.cat:2445/1796382026-05-29T05:05:01Z
dc.title.none.fl_str_mv Efficacy and safety of ritonavir dose reduction based on the tipranavir inhibitory quotient in HIV-infected patients on salvage antiretroviral therapy with tipranavir/ritonavir
title Efficacy and safety of ritonavir dose reduction based on the tipranavir inhibitory quotient in HIV-infected patients on salvage antiretroviral therapy with tipranavir/ritonavir
spellingShingle Efficacy and safety of ritonavir dose reduction based on the tipranavir inhibitory quotient in HIV-infected patients on salvage antiretroviral therapy with tipranavir/ritonavir
Moltó, José
VIH (Virus)
Administració de medicaments
Efectes secundaris dels medicaments
HIV (Viruses)
Administration of drugs
Drug side effects
title_short Efficacy and safety of ritonavir dose reduction based on the tipranavir inhibitory quotient in HIV-infected patients on salvage antiretroviral therapy with tipranavir/ritonavir
title_full Efficacy and safety of ritonavir dose reduction based on the tipranavir inhibitory quotient in HIV-infected patients on salvage antiretroviral therapy with tipranavir/ritonavir
title_fullStr Efficacy and safety of ritonavir dose reduction based on the tipranavir inhibitory quotient in HIV-infected patients on salvage antiretroviral therapy with tipranavir/ritonavir
title_full_unstemmed Efficacy and safety of ritonavir dose reduction based on the tipranavir inhibitory quotient in HIV-infected patients on salvage antiretroviral therapy with tipranavir/ritonavir
title_sort Efficacy and safety of ritonavir dose reduction based on the tipranavir inhibitory quotient in HIV-infected patients on salvage antiretroviral therapy with tipranavir/ritonavir
dc.creator.none.fl_str_mv Moltó, José
Valle, Marta
Santos, José Ramón
Miranda, Cristina
Cedeño, Samandhy
Negredo, Eugènia
Yritia, Mercedes
Videla, Sebastià
Clotet, Bonaventura, 1953-
author Moltó, José
author_facet Moltó, José
Valle, Marta
Santos, José Ramón
Miranda, Cristina
Cedeño, Samandhy
Negredo, Eugènia
Yritia, Mercedes
Videla, Sebastià
Clotet, Bonaventura, 1953-
author_role author
author2 Valle, Marta
Santos, José Ramón
Miranda, Cristina
Cedeño, Samandhy
Negredo, Eugènia
Yritia, Mercedes
Videla, Sebastià
Clotet, Bonaventura, 1953-
author2_role author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv VIH (Virus)
Administració de medicaments
Efectes secundaris dels medicaments
HIV (Viruses)
Administration of drugs
Drug side effects
topic VIH (Virus)
Administració de medicaments
Efectes secundaris dels medicaments
HIV (Viruses)
Administration of drugs
Drug side effects
description Ritonavir-related adverse events have been reported in patients taking tipranavir/ritonavir at the licensed dosage of 500/200 mg twice daily (bid). The aim of this open-label, prospective, single-arm pilot study was to evaluate the efficacy and safety of a ritonavir dose reduction to 100 mg bid guided by the tipranavir virtual inhibitory quotient (vIQ) in HIV-infected patients receiving tipranavir/ritonavir 500/200 mg bid whose viral load was <50 copies/ml and whose tipranavir vIQ was >60. Viral load, blood chemistry, and tipranavir and ritonavir trough concentrations (C(trough)) in plasma were determined at baseline and up to 48 weeks. If the tipranavir vIQ fell to <40, the ritonavir dose was increased to 200 mg bid. The primary endpoint was the percentage of treatment failure after 48 weeks. Eleven patients were enrolled. At baseline, the median (IQR) CD4+ T-cell count and vIQ were 380 (231-520) cells/mm(3) and 233.4 (73.8-584.8), respectively. Ten patients (90.9%) maintained a viral load <50 copies/ml at week 48. Geometric mean (95% confidence interval) tipranavir C(trough) decreased from 24.7 (12.9-47.5) mg/l at baseline to 13.6 (7.1-26.2) mg/l at week 48 (p = 0.194), but the ritonavir dose had to be raised in only one patient. Median triglycerides and ALT concentrations decreased from 177.2 (132.9-292.4) mg/dl and 59 (23-128) IU/l at baseline to 158.0 (131.0-186.0) mg/dl and 28 (20-71) IU/l at week 48 (p = 0.047, p = 0.041), respectively. As a conclusion, ritonavir-dose reduction to 100 mg bid as a treatment-simplification strategy guided by the tipranavir vIQ in patients receiving salvage therapy with tipranavir/ritonavir 500/200 mg bid seems to be safe enough to be tested in adequately powered clinical trials.
publishDate 2010
dc.date.none.fl_str_mv 2010
2021
2021
2021
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/2445/179638
url https://hdl.handle.net/2445/179638
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1089/aid.2009.0304
Aids Research and Human Retroviruses, 2010, vol. 26, num. 11, p. 1191-1196
https://doi.org/10.1089/aid.2009.0304
info:eu-repo/grantAgreement/EC/FP7/223131
dc.rights.none.fl_str_mv (c) Mary Ann Liebert, 2010
info:eu-repo/semantics/openAccess
rights_invalid_str_mv (c) Mary Ann Liebert, 2010
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 6 p.
application/pdf
dc.publisher.none.fl_str_mv Mary Ann Liebert
publisher.none.fl_str_mv Mary Ann Liebert
dc.source.none.fl_str_mv Articles publicats en revistes (Patologia i Terapèutica Experimental)
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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