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Reduced darunavir dose is as effective in maintaining HIV suppression as the standard dose in virologically suppressed HIV-infected patients: a randomized clinical trial

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dc.contributor Universitat de Vic - Universitat Central de Catalunya. Càtedra de la Sida i Malalties Relacionades
dc.contributor.author Moltó, José
dc.contributor.author Valle, Marta
dc.contributor.author Ferrer, Elena
dc.contributor.author Domingo, Pere
dc.contributor.author Curran, Adrian
dc.contributor.author Santos, José R.
dc.contributor.author Di Yacovo, María Silvana
dc.contributor.author Miranda, Cristina
dc.contributor.author Podzamczer Palter, Daniel
dc.contributor.author Clotet, Bonaventura
dc.date.accessioned 2015-04-21T06:40:18Z
dc.date.available 2015-04-21T06:40:18Z
dc.date.created 2015
dc.date.issued 2015
dc.identifier.citation Moltó, J., Valle, M., Ferrer, E., Domingo, P., Curran, A., Santos, J. R., et al. (2014). Reduced darunavir dose is as effective in maintaining HIV suppression as the standard dose in virologically suppressed HIV-infected patients: A randomized clinical trial. Journal of Antimicrobial Chemotherapy, 70(4), 1139-1145. ca_ES
dc.identifier.issn 1460-2091
dc.identifier.uri http://hdl.handle.net/10854/3998
dc.description.abstract Objectives: Maximizing ART efficiency is of growing interest. This study assessed the efficacy, safety, pharmacokinetics and economics of a darunavir dose-reduction strategy. Methods: This was a multicentre, randomized, open-label clinical trial in HIV-infected patients with plasma HIV-1 RNA ,50 copies/mL while receiving triple ART including 800 mg of darunavir once daily. Participants were randomized to continue 800 mg of darunavir (DRV800) or to 600 mg of darunavir (DRV600), both once daily. Treatment failure was defined as two consecutive HIV-1 RNA determinations .50 copies/mL or discontinuation of study treatment by week 48. The study was registered at https://www.clinicaltrialsregister.eu (trial number 2011-006272-39). Results: Fifty participants were allocated to each arm. The mean (SD) CD4+ T cell count at baseline was 562 (303) cells/mm3 and HIV-1 RNA had been,50 copies/mL for a median (IQR) of 106.9 (43.4–227.9) weeks before enrolment. At week 48 no treatment failure had occurred in 45/50 (90%) DRV600 patients and in 47/50 (94%) DRV800 patients (difference –4%; 95% CI lower limit, –12.9%). When only patients with virological data were considered, that endpoint was met by 45/48 (94%) in the DRV600 arm and 47/49 (96%) in the DRV800 arm (difference –2.2%; 95% CI lower limit, –9.6%). Darunavir exposure was similar in the two arms. The average reduction in annual cost per successfully treated DRV600-arm patient was US$7273. Conclusions: The efficacy of a darunavir daily dose of 600 mg seemed to be similar to the efficacy of the standard 800 mg dose in virologically suppressed HIV-infected patients on triple ART. This strategy can potentially translate to substantial savings in the cost of care of HIV-infected patients. ca_ES
dc.format application/pdf
dc.format.extent 7 p. ca_ES
dc.language.iso eng ca_ES
dc.publisher Oxford University Press ca_ES
dc.rights Tots els drets reservats ca_ES
dc.rights (c) Oxford University Press
dc.subject.other Sida -- Tractament ca_ES
dc.subject.other VIH (Virus) ca_ES
dc.title Reduced darunavir dose is as effective in maintaining HIV suppression as the standard dose in virologically suppressed HIV-infected patients: a randomized clinical trial ca_ES
dc.type info:eu-repo/semantics/article ca_ES
dc.identifier.doi https://doi.org/10.1093/jac/dku516
dc.relation.publisherversion http://jac.oxfordjournals.org/content/70/4/1139.abstract
dc.rights.accesRights info:eu-repo/semantics/closedAccess ca_ES
dc.type.version info:eu-repo/publishedVersion ca_ES
dc.indexacio Indexat a SCOPUS ca_ES
dc.indexacio Indexat a WOS/JCR

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