SidaSubSaharaV1, PubMed, Corpus, bibRecord, 000E23

Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial.

Identifieur interne : 000E23 ( PubMed/Corpus ); précédent : 000E22; suivant : 000E24

Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial.

Auteurs : Melanie Thompson ; Jacob P. Lalezari ; Richard Kaplan ; Yvett Pinedo ; Otto A Sussmann Pena ; Pedro Cahn ; David A. Stock ; Samit R. Joshi ; George J. Hanna ; Max Lataillade

Source :

Antiviral therapy [ 2040-2058 ] ; 2017.

RBID : pubmed:27922453

Abstract

Fostemsavir is a prodrug of temsavir, an attachment inhibitor that binds directly to HIV-1 gp120, blocking initial viral attachment and entry into host CD4(+) T-cells. Efficacy, safety and dose-response data of fostemsavir in treatment-experienced, HIV-1-infected subjects, through week 48, are reported.

DOI: 10.3851/IMP3112
PubMed: 27922453

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pubmed:27922453

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<author><name sortKey="Thompson, Melanie" sort="Thompson, Melanie" uniqKey="Thompson M" first="Melanie" last="Thompson">Melanie Thompson</name>
<affiliation><nlm:affiliation>AIDS Research Consortium of Atlanta, Atlanta, GA, USA.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Lalezari, Jacob P" sort="Lalezari, Jacob P" uniqKey="Lalezari J" first="Jacob P" last="Lalezari">Jacob P. Lalezari</name>
<affiliation><nlm:affiliation>Quest Clinical Research, San Francisco, CA, USA.</nlm:affiliation>
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<author><name sortKey="Kaplan, Richard" sort="Kaplan, Richard" uniqKey="Kaplan R" first="Richard" last="Kaplan">Richard Kaplan</name>
<affiliation><nlm:affiliation>Desmond Tutu HIV Foundation, Cape Town, South Africa.</nlm:affiliation>
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<author><name sortKey="Pinedo, Yvett" sort="Pinedo, Yvett" uniqKey="Pinedo Y" first="Yvett" last="Pinedo">Yvett Pinedo</name>
<affiliation><nlm:affiliation>Asociacion Civil Via Libre, Lima, Peru.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Pena, Otto A Sussmann" sort="Pena, Otto A Sussmann" uniqKey="Pena O" first="Otto A Sussmann" last="Pena">Otto A Sussmann Pena</name>
<affiliation><nlm:affiliation>Asistencia Cientifica de Alta Complejidad SAS, Bogotá, Columbia.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Cahn, Pedro" sort="Cahn, Pedro" uniqKey="Cahn P" first="Pedro" last="Cahn">Pedro Cahn</name>
<affiliation><nlm:affiliation>Fundacion Huesped, Buenos Aires, Argentina.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Stock, David A" sort="Stock, David A" uniqKey="Stock D" first="David A" last="Stock">David A. Stock</name>
<affiliation><nlm:affiliation>Bristol-Myers Squibb, Wallingford, CT, USA.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Joshi, Samit R" sort="Joshi, Samit R" uniqKey="Joshi S" first="Samit R" last="Joshi">Samit R. Joshi</name>
<affiliation><nlm:affiliation>Bristol-Myers Squibb, Wallingford, CT, USA.</nlm:affiliation>
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<author><name sortKey="Hanna, George J" sort="Hanna, George J" uniqKey="Hanna G" first="George J" last="Hanna">George J. Hanna</name>
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<author><name sortKey="Lataillade, Max" sort="Lataillade, Max" uniqKey="Lataillade M" first="Max" last="Lataillade">Max Lataillade</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial.</title>
<author><name sortKey="Thompson, Melanie" sort="Thompson, Melanie" uniqKey="Thompson M" first="Melanie" last="Thompson">Melanie Thompson</name>
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<author><name sortKey="Lalezari, Jacob P" sort="Lalezari, Jacob P" uniqKey="Lalezari J" first="Jacob P" last="Lalezari">Jacob P. Lalezari</name>
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<author><name sortKey="Kaplan, Richard" sort="Kaplan, Richard" uniqKey="Kaplan R" first="Richard" last="Kaplan">Richard Kaplan</name>
<affiliation><nlm:affiliation>Desmond Tutu HIV Foundation, Cape Town, South Africa.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Pinedo, Yvett" sort="Pinedo, Yvett" uniqKey="Pinedo Y" first="Yvett" last="Pinedo">Yvett Pinedo</name>
<affiliation><nlm:affiliation>Asociacion Civil Via Libre, Lima, Peru.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Pena, Otto A Sussmann" sort="Pena, Otto A Sussmann" uniqKey="Pena O" first="Otto A Sussmann" last="Pena">Otto A Sussmann Pena</name>
<affiliation><nlm:affiliation>Asistencia Cientifica de Alta Complejidad SAS, Bogotá, Columbia.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Cahn, Pedro" sort="Cahn, Pedro" uniqKey="Cahn P" first="Pedro" last="Cahn">Pedro Cahn</name>
<affiliation><nlm:affiliation>Fundacion Huesped, Buenos Aires, Argentina.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Stock, David A" sort="Stock, David A" uniqKey="Stock D" first="David A" last="Stock">David A. Stock</name>
<affiliation><nlm:affiliation>Bristol-Myers Squibb, Wallingford, CT, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Joshi, Samit R" sort="Joshi, Samit R" uniqKey="Joshi S" first="Samit R" last="Joshi">Samit R. Joshi</name>
<affiliation><nlm:affiliation>Bristol-Myers Squibb, Wallingford, CT, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Hanna, George J" sort="Hanna, George J" uniqKey="Hanna G" first="George J" last="Hanna">George J. Hanna</name>
<affiliation><nlm:affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Lataillade, Max" sort="Lataillade, Max" uniqKey="Lataillade M" first="Max" last="Lataillade">Max Lataillade</name>
<affiliation><nlm:affiliation>Bristol-Myers Squibb, Wallingford, CT, USA.</nlm:affiliation>
</affiliation>
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<series><title level="j">Antiviral therapy</title>
<idno type="eISSN">2040-2058</idno>
<imprint><date when="2017" type="published">2017</date>
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<front><div type="abstract" xml:lang="en">Fostemsavir is a prodrug of temsavir, an attachment inhibitor that binds directly to HIV-1 gp120, blocking initial viral attachment and entry into host CD4(+) T-cells. Efficacy, safety and dose-response data of fostemsavir in treatment-experienced, HIV-1-infected subjects, through week 48, are reported.</div>
</front>
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<pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">27922453</PMID>
<DateCreated><Year>2016</Year>
<Month>12</Month>
<Day>06</Day>
</DateCreated>
<DateRevised><Year>2017</Year>
<Month>06</Month>
<Day>27</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2040-2058</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>22</Volume>
<Issue>3</Issue>
<PubDate><Year>2017</Year>
</PubDate>
</JournalIssue>
<Title>Antiviral therapy</Title>
<ISOAbbreviation>Antivir. Ther. (Lond.)</ISOAbbreviation>
</Journal>
<ArticleTitle>Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial.</ArticleTitle>
<Pagination><MedlinePgn>215-223</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.3851/IMP3112</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Fostemsavir is a prodrug of temsavir, an attachment inhibitor that binds directly to HIV-1 gp120, blocking initial viral attachment and entry into host CD4(+) T-cells. Efficacy, safety and dose-response data of fostemsavir in treatment-experienced, HIV-1-infected subjects, through week 48, are reported.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">AI438011 is an ongoing Phase IIb, randomized, active-controlled trial (NCT01384734). Subjects were randomized 1:1:1:1:1 into five arms: fostemsavir (400 mg twice daily, 800 mg twice daily, 600 mg once daily or 1,200 mg once daily) and a reference arm (ritonavir-boosted atazanavir [ATV/r] 300/100 mg once daily), each with a backbone of raltegravir 400 mg twice daily plus tenofovir disoproxil fumarate 300 mg once daily.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">In total, 251 subjects were treated. Through week 48, the proportion of fostemsavir subjects with HIV-1 RNA <50 copies/ml was 61-82% and 77-95% (modified intent-to-treat [mITT] and observed analysis, respectively); 71% and 88% for ATV/r subjects (mITT and observed). Observed virological response rates were 74-100% versus 96% (fostemsavir versus ATV/r) in subjects with baseline viral load <100,000 copies/ml and 60-91% versus 71% when baseline viral load was ≥100,000 copies/ml. Across fostemsavir arms, median CD4(+) T-cell count increases from baseline were 145-186 cells/µl and 142 cells/µl for the ATV/r arm. Fostemsavir doses were generally well tolerated and no fostemsavir-related adverse events led to discontinuation.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Through week 48, fostemsavir continued to be well tolerated and showed similar efficacy to ATV/r. These results support the ongoing Phase III trial in heavily treatment-experienced adults with limited therapeutic options (≤2 classes of active antiretrovirals remaining). ClinicalTrials.gov identifier: NCT01384734.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Thompson</LastName>
<ForeName>Melanie</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>AIDS Research Consortium of Atlanta, Atlanta, GA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lalezari</LastName>
<ForeName>Jacob P</ForeName>
<Initials>JP</Initials>
<AffiliationInfo><Affiliation>Quest Clinical Research, San Francisco, CA, USA.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Kaplan</LastName>
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</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Pinedo</LastName>
<ForeName>Yvett</ForeName>
<Initials>Y</Initials>
<AffiliationInfo><Affiliation>Asociacion Civil Via Libre, Lima, Peru.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Pena</LastName>
<ForeName>Otto A Sussmann</ForeName>
<Initials>OAS</Initials>
<AffiliationInfo><Affiliation>Asistencia Cientifica de Alta Complejidad SAS, Bogotá, Columbia.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Cahn</LastName>
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</AffiliationInfo>
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<Initials>DA</Initials>
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</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Joshi</LastName>
<ForeName>Samit R</ForeName>
<Initials>SR</Initials>
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</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hanna</LastName>
<ForeName>George J</ForeName>
<Initials>GJ</Initials>
<AffiliationInfo><Affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lataillade</LastName>
<ForeName>Max</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Bristol-Myers Squibb, Wallingford, CT, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><CollectiveName>AI438011 study team</CollectiveName>
</Author>
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<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
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<ArticleDate DateType="Electronic"><Year>2016</Year>
<Month>12</Month>
<Day>06</Day>
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<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Antivir Ther</MedlineTA>
<NlmUniqueID>9815705</NlmUniqueID>
<ISSNLinking>1359-6535</ISSNLinking>
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Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial.

Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial.

Source :

Abstract

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Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

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