Cerebrospinal fluid and plasma lopinavir concentrations and viral response in virologically suppressed patients switching to lopinavir/ritonavir monotherapy once daily.

Tiraboschi, Juan M.; Knobel Freud, Hernando; Imaz, Arkaitz; Villar García, Judit; Ferrer, Elena; Saumoy, Maria; González Mena, Alicia; Rozas, Nerea; Vila, Antonia; Niubó, Jordi; Curto, Jordi; Daniel Podzamczer

Cerebrospinal fluid and plasma lopinavir concentrations and viral response in virologically suppressed patients switching to lopinavir/ritonavir monotherapy once daily.

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dc.contributor.author Tiraboschi, Juan M.ca
dc.contributor.author Knobel Freud, Hernandoca
dc.contributor.author Imaz, Arkaitzca
dc.contributor.author Villar García, Juditca
dc.contributor.author Ferrer, Elenaca
dc.contributor.author Saumoy, Mariaca
dc.contributor.author González Mena, Aliciaca
dc.contributor.author Rozas, Nereaca
dc.contributor.author Vila, Antoniaca
dc.contributor.author Niubó, Jordica
dc.contributor.author Curto, Jordica
dc.contributor.author Daniel Podzamczerca
dc.date.accessioned 2016-09-02T08:31:06Z
dc.date.available 2016-09-02T08:31:06Z
dc.date.issued 2016
dc.description.abstract BACKGROUND: Lopinavir/ritonavir (LPV/r) monotherapy is used in selected virologically suppressed HIV-infected patients. Some would prefer a once-daily (OD) dose instead of the usual twice-daily dose to favour adherence. However, trough concentrations of the drug in blood and particularly in cerebrospinal fluid (CSF) may not be adequate to maintain viral suppression. METHODS: Prospective, open-label pilot study to evaluate the efficacy and safety of LPV/r monotherapy OD. HIV-1-infected patients, virologically suppressed for at least 6 months were enrolled. HIV viral load (VL) was determined at baseline and at weeks 4, 8, 12, 16, 24, 36 and 48. Lumbar puncture was performed in a subgroup of patients to evaluate CSF VL and CSF LPV concentrations. RESULTS: A total of 21 patients were included. At week 48, 85.7% (n=18) showed viral suppression (VL<40 copies/ml). Two patients had viral failure (9.5%) and a third was withdrawn from the study because of gastrointestinal symptoms. Nine patients were enrolled in the substudy. CSF VL was <40 copies/ml in all cases. Median (range) LPV concentration was 9.78 ng/ml (1.93-78.3) in CSF and 1,970 (154-16,700) ng/ml in plasma; the CSF/plasma ratio was 0.004 (0.001-0.186). CONCLUSIONS: In this small pilot study, LPV/r monotherapy OD maintained plasma HIV RNA suppression at 48 weeks in most patients, with no cases of CSF viral escape. However, CSF LPV concentrations were close to the 50% inhibitory concentration threshold in several patients; hence, this intervention should be avoided in patients with advanced immune suppression and/or those individuals presenting with significant comorbidities such as hepatitis C coinfection.ca
dc.description.sponsorship This study was partially funded by the RD12/0017/0013 project, a part of the Plan Nacional 223 R+D+I, and was cofinanced by the ISCIII, Subdirección General de Evaluación y el 224 Fondo Europeo de Desarrollo Regional (FEDER).
dc.format.mimetype application/pdfca
dc.identifier.citation Tiraboschi JM1, Knobel H, Imaz A, Villar J, Ferrer E, Saumoy M, González A. et al. Cerebrospinal fluid and plasma lopinavir concentrations and viral response in virologically suppressed patients switching to lopinavir/ritonavir monotherapy once daily. Antivir Ther. 2016;21(4):359-63. doi: 10.3851/IMP3015ca
dc.identifier.doi http://dx.doi.org/10.3851/IMP3015
dc.identifier.issn 1359-6535
dc.identifier.uri http://hdl.handle.net/10230/27274
dc.language.iso engca
dc.publisher International Medical Pressca
dc.relation.ispartof Antiviral Therapy. 2016;21(4):359-63
dc.rights This is the author’s version of a work accepted for publication by International Medical Press. Changes resulting from the publishing process, including peer review, editing and formatting, might not be reflected in this document. A definitive version was published in Antiviral Therapy, (21(4)), , ©2016 International Medical Press.http://dx.doi.org/10.3851/IMP3015ca
dc.rights.accessRights info:eu-repo/semantics/openAccessca
dc.subject.other Malalties transmissiblesca
dc.subject.other VIH (Virus) -- Aspectes immunològicsca
dc.title Cerebrospinal fluid and plasma lopinavir concentrations and viral response in virologically suppressed patients switching to lopinavir/ritonavir monotherapy once daily.ca
dc.type info:eu-repo/semantics/articleca
dc.type.version info:eu-repo/semantics/acceptedVersionca

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