<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet type="text/xsl" href="static/style.xsl"?><OAI-PMH xmlns="http://www.openarchives.org/OAI/2.0/" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://www.openarchives.org/OAI/2.0/ http://www.openarchives.org/OAI/2.0/OAI-PMH.xsd"><responseDate>2026-06-14T05:05:58Z</responseDate><request verb="GetRecord" identifier="oai:repisalud.isciii.es:20.500.12105/9641" metadataPrefix="mets">https://repisalud.isciii.es/rest/oai/request</request><GetRecord><record><header><identifier>oai:repisalud.isciii.es:20.500.12105/9641</identifier><datestamp>2025-04-08T12:47:19Z</datestamp><setSpec>com_20.500.12105_2052</setSpec><setSpec>com_20.500.12105_2051</setSpec><setSpec>com_20.500.12105_15322</setSpec><setSpec>col_20.500.12105_19609</setSpec><setSpec>col_20.500.12105_16958</setSpec><setSpec>col_20.500.12105_16978</setSpec><setSpec>col_20.500.12105_16987</setSpec></header><metadata><mets xmlns="http://www.loc.gov/METS/" xmlns:doc="http://www.lyncode.com/xoai" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" ID="&#xa;&#x9;&#x9;&#x9;&#x9;DSpace_ITEM_20.500.12105-9641" TYPE="DSpace ITEM" PROFILE="DSpace METS SIP Profile 1.0" xsi:schemaLocation="http://www.loc.gov/METS/ http://www.loc.gov/standards/mets/mets.xsd" OBJID="&#xa;&#x9;&#x9;&#x9;&#x9;hdl:20.500.12105/9641">
   <metsHdr CREATEDATE="2026-06-14T07:05:58Z">
      <agent ROLE="CUSTODIAN" TYPE="ORGANIZATION">
         <name>Repisalud</name>
      </agent>
   </metsHdr>
   <dmdSec ID="DMD_20.500.12105_9641">
      <mdWrap MDTYPE="MODS">
         <xmlData xmlns:mods="http://www.loc.gov/mods/v3" xsi:schemaLocation="http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-1.xsd">
            <mods:mods xsi:schemaLocation="http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-1.xsd">
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Falcon-Neyra, Lola</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Palladino, Claudia</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Navarro Gómez, María Luisa</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Soler-Palacín, Pere</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>González-Tomé, María Isabel</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Jimenez de Ory, Santiago</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Frick, Marie Antoinette</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Fortuny, Claudia</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Noguera-Julian, Antoni</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Bermúdez Moreno, Elena</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Santos, Juan Luis</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Olbrich, Peter</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>López-Cortés, Luis F</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Briz, Veronica</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">author</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Neth, Olaf</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">funder</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Red de Investigación Cooperativa en Investigación en Sida (España)</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">funder</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Instituto de Salud Carlos III</mods:namePart>
               </mods:name>
               <mods:name>
                  <mods:role>
                     <mods:roleTerm type="text">funder</mods:roleTerm>
                  </mods:role>
                  <mods:namePart>Fundação para a Ciência e Tecnologia (Portugal)</mods:namePart>
               </mods:name>
               <mods:extension>
                  <mods:dateAccessioned encoding="iso8601">2020-04-21T08:39:06Z</mods:dateAccessioned>
               </mods:extension>
               <mods:extension>
                  <mods:dateAvailable encoding="iso8601">2020-04-21T08:39:06Z</mods:dateAvailable>
               </mods:extension>
               <mods:originInfo>
                  <mods:dateIssued encoding="iso8601">2016-06</mods:dateIssued>
               </mods:originInfo>
               <mods:identifier type="citation">Medicine (Baltimore)  . 2016 Jun;95(24):e3842.</mods:identifier>
               <mods:identifier type="doi">10.1097/MD.0000000000003842</mods:identifier>
               <mods:identifier type="e-issn">1536-5964</mods:identifier>
               <mods:identifier type="issn">0025-7974</mods:identifier>
               <mods:identifier type="journal">Medicine</mods:identifier>
               <mods:identifier type="pubmedID">27310962</mods:identifier>
               <mods:identifier type="uri">http://hdl.handle.net/20.500.12105/9641</mods:identifier>
               <mods:abstract>To 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 &lt; 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.</mods:abstract>
               <mods:language>
                  <mods:languageTerm authority="rfc3066">eng</mods:languageTerm>
               </mods:language>
               <mods:accessCondition type="useAndReproduction"/>
               <mods:titleInfo>
                  <mods:title>Off-label use of rilpivirine in combination with emtricitabine and tenofovir in HIV-1-infected pediatric patients: A multicenter study</mods:title>
               </mods:titleInfo>
               <mods:genre>research article</mods:genre>
            </mods:mods>
         </xmlData>
      </mdWrap>
   </dmdSec>
   <amdSec ID="TMD_20.500.12105_9641">
      <rightsMD ID="RIG_20.500.12105_9641">
         <mdWrap MIMETYPE="text/plain" MDTYPE="OTHER" OTHERMDTYPE="DSpaceDepositLicense">
            <binData>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</binData>
         </mdWrap>
      </rightsMD>
   </amdSec>
   <amdSec ID="FO_20.500.12105_9641_1">
      <techMD ID="TECH_O_20.500.12105_9641_1">
         <mdWrap MDTYPE="PREMIS">
            <xmlData xmlns:premis="http://www.loc.gov/standards/premis" xsi:schemaLocation="http://www.loc.gov/standards/premis http://www.loc.gov/standards/premis/PREMIS-v1-0.xsd">
               <premis:premis>
                  <premis:object>
                     <premis:objectIdentifier>
                        <premis:objectIdentifierType>URL</premis:objectIdentifierType>
                        <premis:objectIdentifierValue>https://repisalud.isciii.es/bitstreams/db4c6af3-3dc2-419c-8a68-4fc640516ab4/download</premis:objectIdentifierValue>
                     </premis:objectIdentifier>
                     <premis:objectCategory>File</premis:objectCategory>
                     <premis:objectCharacteristics>
                        <premis:fixity>
                           <premis:messageDigestAlgorithm>MD5</premis:messageDigestAlgorithm>
                           <premis:messageDigest>55e81740d5f583f72823275497421ffb</premis:messageDigest>
                        </premis:fixity>
                        <premis:size>188351</premis:size>
                        <premis:format>
                           <premis:formatDesignation>
                              <premis:formatName>application/pdf</premis:formatName>
                           </premis:formatDesignation>
                        </premis:format>
                     </premis:objectCharacteristics>
                     <premis:originalName>OffLabelUseOf_2016.pdf</premis:originalName>
                  </premis:object>
               </premis:premis>
            </xmlData>
         </mdWrap>
      </techMD>
   </amdSec>
   <amdSec ID="FT_20.500.12105_9641_3">
      <techMD ID="TECH_T_20.500.12105_9641_3">
         <mdWrap MDTYPE="PREMIS">
            <xmlData xmlns:premis="http://www.loc.gov/standards/premis" xsi:schemaLocation="http://www.loc.gov/standards/premis http://www.loc.gov/standards/premis/PREMIS-v1-0.xsd">
               <premis:premis>
                  <premis:object>
                     <premis:objectIdentifier>
                        <premis:objectIdentifierType>URL</premis:objectIdentifierType>
                        <premis:objectIdentifierValue>https://repisalud.isciii.es/bitstreams/cbbb1aec-f26d-4867-af38-3b5217adc13b/download</premis:objectIdentifierValue>
                     </premis:objectIdentifier>
                     <premis:objectCategory>File</premis:objectCategory>
                     <premis:objectCharacteristics>
                        <premis:fixity>
                           <premis:messageDigestAlgorithm>MD5</premis:messageDigestAlgorithm>
                           <premis:messageDigest>b9e36892064429f87d94442189c918eb</premis:messageDigest>
                        </premis:fixity>
                        <premis:size>26646</premis:size>
                        <premis:format>
                           <premis:formatDesignation>
                              <premis:formatName>text/plain</premis:formatName>
                           </premis:formatDesignation>
                        </premis:format>
                     </premis:objectCharacteristics>
                     <premis:originalName>OffLabelUseOf_2016.pdf.txt</premis:originalName>
                  </premis:object>
               </premis:premis>
            </xmlData>
         </mdWrap>
      </techMD>
   </amdSec>
   <fileSec>
      <fileGrp USE="ORIGINAL">
         <file ID="BITSTREAM_ORIGINAL_20.500.12105_9641_1" MIMETYPE="application/pdf" SEQ="1" SIZE="188351" CHECKSUM="55e81740d5f583f72823275497421ffb" CHECKSUMTYPE="MD5" ADMID="FO_20.500.12105_9641_1" GROUPID="GROUP_BITSTREAM_20.500.12105_9641_1">
            <FLocat LOCTYPE="URL" xlink:type="simple" xlink:href="https://repisalud.isciii.es/bitstreams/db4c6af3-3dc2-419c-8a68-4fc640516ab4/download"/>
         </file>
      </fileGrp>
      <fileGrp USE="TEXT">
         <file ID="BITSTREAM_TEXT_20.500.12105_9641_3" MIMETYPE="text/plain" SEQ="3" SIZE="26646" CHECKSUM="b9e36892064429f87d94442189c918eb" CHECKSUMTYPE="MD5" ADMID="FT_20.500.12105_9641_3" GROUPID="GROUP_BITSTREAM_20.500.12105_9641_3">
            <FLocat LOCTYPE="URL" xlink:type="simple" xlink:href="https://repisalud.isciii.es/bitstreams/cbbb1aec-f26d-4867-af38-3b5217adc13b/download"/>
         </file>
      </fileGrp>
   </fileSec>
   <structMap LABEL="DSpace Object" TYPE="LOGICAL">
      <div TYPE="DSpace Object Contents" ADMID="DMD_20.500.12105_9641">
         <div TYPE="DSpace BITSTREAM">
            <fptr FILEID="BITSTREAM_ORIGINAL_20.500.12105_9641_1"/>
         </div>
      </div>
   </structMap>
</mets></metadata></record></GetRecord></OAI-PMH>