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Off-label use of rilpivirine in combination with emtricitabine and tenofovir in HIV-1-infected pediatric patients A multicenter study

2016Journal article Open access
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dc.contributor.authorFalcon-Neyra, Lola
dc.contributor.authorPalladino, Claudia
dc.contributor.authorGomez, María Luisa Navarro
dc.contributor.authorSoler-Palacin, Pere
dc.contributor.authorGonzalez-Tome, María Isabel
dc.contributor.authorDe Ory, Santiago J.
dc.contributor.authorFrick, Marie Antoinette
dc.contributor.authorFortuny, Clàudia
dc.contributor.authorNoguera-Julian, Antoni
dc.contributor.authorMoreno, Elena Bermúdez
dc.contributor.authorSantos, Juan Luis
dc.contributor.authorOlbrich, Peter
dc.contributor.authorLópez-Cortés, Luis F.
dc.contributor.authorBriz, Verónica
dc.contributor.authorNeth, Olaf
dc.date.accessioned2024-01-24T19:56:51Z
dc.date.available2024-01-24T19:56:51Z
dc.date.issued2016
dc.date.updated2023-02-09T15:06:56Z
dc.descriptionCopyright © 2016 The Authors. This is an open access article distributed under the Creative Commons Attribution License 4.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0pt_PT
dc.description.abstractTo assess the safety and efficacy of rilpivirine in combination with emtricitabine and tenofovir (RPV/FTC/TDF) as a once-daily single-tablet regimen (STR) in HIV-1-infected children and adolescents we performed a multicenter case series study of HIV-1-infected patients. Inclusion criteria were initiation of therapy with RPV/FTC/TDF before the age of 18. Patients were divided into undetectable viral load (uVL) group, HIV-1 RNA < 20 copies/mL on stable combined antiretroviral therapy (cART), and detectable viral load (dVL) group, HIV-1 RNA ≥ 20 copies/mL at RPV/FTC/TDF initiation. Patients were monitored from the date of RPV/FTC/TDF initiation until June 30, 2015, RPV/FTC/TDF discontinuation or failure to follow-up. Seventeen patients (8 in uVL and 9 in dVL group) with age between 11.6 and 17.6 were included. Reasons for switching were toxicity (n = 4) and simplification (n = 4) in uVL; viral failure (n = 8) and cART initiation (n = 1) in the dVL group. After a median follow-up of 90 (uVL) and 40 weeks (dVL), 7/8 (86%) patients maintained and 8/9 (89%) achieved and maintained HIV-1 suppression. Median CD4 count increased from 542 to 780/μL (uVL, P = 0.069) and 480 to 830/μL (dVL, P = 0.051). Five patients (2 in uVL and 3 in dVL) improved their immunological status from moderate to no immunosuppression. Serum lipid profiles improved in both groups; cholesterol dropped significantly in the dVL group (P = 0.008). Grade 1 laboratory adverse events (AEs) were observed in 3 patients. No clinical AEs occurred. Adherence was complete in 9 patients (5 in uVL and 4 in dVL); 1 adolescent interrupted treatment. Once-daily STR with RPV/FTC/TDF may be a safe and effective choice in selected HIV-1-infected adolescents and children.pt_PT
dc.description.sponsorshipFinancial support was provided by the Instituto de Salud Carlos III through the Red Temática de Investigación Cooperativa en Sida (ISCIII-RETIC RD06/006; RD12/0017/0035, and RD12/0017/0037) and FIPSE (grant number: 36-0910-10). This work has been also supported by grants from Instituto de Salud Carlos III (Ref. MPY 1039/14 to VB). CP is supported by the Portuguese Fundação para a Ciência e Tecnologia (FCT) (grant number SFRH/BPD/77448/2011, part of the EDCTP2 program supported by the European Union). VB is supported by the Miguel Servet program run by the Fondo de Investigación Sanitaria (ISCIII) (grant number CP13/00098).pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationFalcon-Neyra L, Palladino C, Navarro Gómez ML, Soler-Palacín P, González-Tomé MI, De Ory SJ, et al. Off-label use of rilpivirine in combination with emtricitabine and tenofovir in HIV-1-infected pediatric patients: A multicenter study. Medicine [Internet]. junho de 2016;95(24):e3842. Disponível em: https://journals.lww.com/00005792-201606140-00021pt_PT
dc.identifier.doi10.1097/MD.0000000000003842pt_PT
dc.identifier.eid2-s2.0-84976351380
dc.identifier.slugcv-prod-1185527
dc.identifier.urihttp://hdl.handle.net/10451/62089
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherWolters Kluwer Healthpt_PT
dc.relationEPIDEMIOLOGY, PATHOGENESIS AND DETERMINANTS OF HIV-1 TRANSMISSION AND DISEASE PROGRESSION IN THE ANGOLAN PERINATAL HIV COHORT APEHC
dc.relation.publisherversionhttps://journals.lww.com/md-journal/fulltext/2016/06140/off_label_use_of_rilpivirine_in_combination_with.21.aspxpt_PT
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/pt_PT
dc.subjectadolescentspt_PT
dc.subjectantiretroviral therapypt_PT
dc.subjectchildrenpt_PT
dc.subjectHIV-1pt_PT
dc.subjectrilpivirinept_PT
dc.titleOff-label use of rilpivirine in combination with emtricitabine and tenofovir in HIV-1-infected pediatric patients A multicenter studypt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.awardTitleEPIDEMIOLOGY, PATHOGENESIS AND DETERMINANTS OF HIV-1 TRANSMISSION AND DISEASE PROGRESSION IN THE ANGOLAN PERINATAL HIV COHORT APEHC
oaire.awardURIinfo:eu-repo/grantAgreement/FCT/OE/SFRH%2FBPD%2F77448%2F2011/PT
oaire.citation.issue24pt_PT
oaire.citation.startPagee3842pt_PT
oaire.citation.titleMedicine (United States)pt_PT
oaire.citation.volume95pt_PT
oaire.fundingStreamOE
person.familyNamePalladino
person.givenNameClaudia
person.identifier.ciencia-id721D-6851-20D5
person.identifier.orcid0000-0002-8148-0928
project.funder.identifierhttp://doi.org/10.13039/501100001871
project.funder.nameFundação para a Ciência e a Tecnologia
rcaap.cv.cienciaid721D-6851-20D5 | Claudia Palladino
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublication96b2385b-89f4-428a-9ab2-6fdb5514541b
relation.isAuthorOfPublication.latestForDiscovery96b2385b-89f4-428a-9ab2-6fdb5514541b
relation.isProjectOfPublication5c32faa6-8a9f-4fd4-b3a7-fa871a159d96
relation.isProjectOfPublication.latestForDiscovery5c32faa6-8a9f-4fd4-b3a7-fa871a159d96

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