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Broad-spectrum Investigational Agent GS-5734 for the Treatment of Ebola, MERS Coronavirus and Other Pathogenic Viral Infections with High Outbreak Potential

Identifieur interne : 000640 ( Pmc/Checkpoint ); précédent : 000639; suivant : 000641

Broad-spectrum Investigational Agent GS-5734 for the Treatment of Ebola, MERS Coronavirus and Other Pathogenic Viral Infections with High Outbreak Potential

Auteurs : Robert Jordan ; Alison Hogg ; Travis Warren ; Emmie De Wit ; Timothy Sheahan ; Michael Lo ; Veronica Soloveva ; Jessica Weidner ; Laura Gomba ; Friederike Feldmann ; Jacqueline Cronin ; Amy Sims ; Adam Cockrell ; Joy Feng ; Iva Trantcheva ; Darius Babusis ; Danielle Porter-Poulin ; Roy Bannister ; Richard Mackman ; Dustin Siegel ; Adrian Ray ; Mark Denison [États-Unis] ; Christina Spiropoulou ; Stuart Nichol ; Tomas Cihlar ; Ralph Baric ; Heinrich Feldmann ; Sina Bavari

Source :

RBID : PMC:5630887

Abstract

AbstractBackground

Recent viral outbreaks with significant mortality such as Ebola virus (EBOV), SARS-coronavirus (CoV), and MERS-CoV reinforced the need for effective antiviral therapeutics to control future epidemics. GS-5734 is a novel nucleotide analog prodrug in the development for treatment of EBOV.

Method

Antiviral activity of GS-5734 has been established in vitro against a wide range of pathogenic RNA virus families, including filoviruses, coronaviruses, and paramyxoviruses (EC50 = 37 to 200 nM) (Warren et al., Nature 2016; Sheahan et al., Sci Transl Med 2017; Lo et al., Sci Rep 2017). Herein, we describe the in vivo translation of the broad-spectrum activity of GS-5734 in relevant animal disease models for Ebola, Marburg, MERS-CoV, and Nipah.

Result

Therapeutic efficacy against multiple filoviruses with 80–100% survival was observed in rhesus monkeys infected with lethal doses of EBOV (Kikwit/1995 or Makona/2014) or Marburg virus and treated with once daily intravenous (IV) administration of 5 to 10 mg/kg GS-5734 beginning 3 to 5 days post-infection (p.i.). In all rhesus monkey filovirus infection models, GS-5734 significantly reduced systemic viremia and ameliorated severe clinical disease signs and anatomic pathology. In mice infected with MERS-CoV, twice daily subcutaneous administration of 25 mg/kg GS-5734 beginning 1 day p.i. significantly reduced lung viral load and improved respiratory function. In rhesus monkeys, once-daily IV administration of 5 mg/kg GS-5734 initiated 1 day prior to MERS-CoV infection reduced lung viral load, improved clinical disease signs, and ameliorated severe lung pathology. Finally, in African green monkeys infected with a lethal dose of Nipah virus therapeutic once-daily IV administration of 10 mg/kg GS-5734, starting 1 day p.i. resulted in 100% survival to at least day 35 without any major respiratory or CNS symptoms.

Conclusion

GS-5734 is currently being tested in a phase 2 study in male Ebola survivors with persistent viral RNA in semen. Lyophilized drug formulation has been developed that can be administered to humans via a 30-minutes IV infusion and does not require cold chain storage. Together, these results support further development of GS-5734 as a broad-spectrum antiviral to treat viral infections with high mortality and significant outbreak potential.

Disclosures

R. Jordan, Gilead: Employee, Salary. J. Feng, Gilead: Employee, Salary

I. Trantcheva, Gilead: Employee, Salary. D. Babusis, Gilead: Employee, Salary. D. Porter-Poulin, Gilead: Employee, Salary. R. Bannister, Gilead: Employee, Salary

R. Mackman, Gilead: Employee, Salary. D. Siegel, Gilead: Employee, Salary

A. Ray, Gilead: Employee, Salary, T. Cihlar, Gilead: Employee, Salary.


Url:
DOI: 10.1093/ofid/ofx180.008
PubMed: NONE
PubMed Central: 5630887


Affiliations:

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PMC:5630887

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<name sortKey="Spiropoulou, Christina" sort="Spiropoulou, Christina" uniqKey="Spiropoulou C" first="Christina" last="Spiropoulou">Christina Spiropoulou</name>
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<title xml:lang="en" level="a" type="main">Broad-spectrum Investigational Agent GS-5734 for the Treatment of Ebola, MERS Coronavirus and Other Pathogenic Viral Infections with High Outbreak Potential</title>
<author>
<name sortKey="Jordan, Robert" sort="Jordan, Robert" uniqKey="Jordan R" first="Robert" last="Jordan">Robert Jordan</name>
<affiliation>
<nlm:aff id="AF0001">
<institution>Gilead Sciences, Inc.</institution>
,
<addr-line>Foster City, California</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Hogg, Alison" sort="Hogg, Alison" uniqKey="Hogg A" first="Alison" last="Hogg">Alison Hogg</name>
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<nlm:aff id="AF0001">
<institution>Gilead Sciences, Inc.</institution>
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<addr-line>Foster City, California</addr-line>
;</nlm:aff>
</affiliation>
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<name sortKey="Warren, Travis" sort="Warren, Travis" uniqKey="Warren T" first="Travis" last="Warren">Travis Warren</name>
<affiliation>
<nlm:aff id="AF0002">
<institution>United States Army Medical Research Institute of Infectious Diseases</institution>
,
<addr-line>Frederick, Maryland</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="De Wit, Emmie" sort="De Wit, Emmie" uniqKey="De Wit E" first="Emmie" last="De Wit">Emmie De Wit</name>
<affiliation>
<nlm:aff id="AF0003">
<institution>Laboratory of Virology, Division of Intramural Research, National Institute for Allergy and Infectious Diseases, National Institutes of Health, Rocky Mountain Laboratories</institution>
,
<addr-line>Hamilton, Montana</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Sheahan, Timothy" sort="Sheahan, Timothy" uniqKey="Sheahan T" first="Timothy" last="Sheahan">Timothy Sheahan</name>
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<nlm:aff id="AF0004">
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,
<addr-line>Chapel Hill, North Carolina</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Lo, Michael" sort="Lo, Michael" uniqKey="Lo M" first="Michael" last="Lo">Michael Lo</name>
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<nlm:aff id="AF0005">
<institution>Centers for Disease Control and Prevention</institution>
,
<addr-line>Atlanta, Georgia</addr-line>
;</nlm:aff>
</affiliation>
</author>
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<name sortKey="Soloveva, Veronica" sort="Soloveva, Veronica" uniqKey="Soloveva V" first="Veronica" last="Soloveva">Veronica Soloveva</name>
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,
<addr-line>Frederick, Maryland</addr-line>
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</affiliation>
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<name sortKey="Weidner, Jessica" sort="Weidner, Jessica" uniqKey="Weidner J" first="Jessica" last="Weidner">Jessica Weidner</name>
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<addr-line>Frederick, Maryland</addr-line>
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<name sortKey="Gomba, Laura" sort="Gomba, Laura" uniqKey="Gomba L" first="Laura" last="Gomba">Laura Gomba</name>
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,
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</affiliation>
</author>
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<name sortKey="Feldmann, Friederike" sort="Feldmann, Friederike" uniqKey="Feldmann F" first="Friederike" last="Feldmann">Friederike Feldmann</name>
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<nlm:aff id="AF0003">
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,
<addr-line>Hamilton, Montana</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Cronin, Jacqueline" sort="Cronin, Jacqueline" uniqKey="Cronin J" first="Jacqueline" last="Cronin">Jacqueline Cronin</name>
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<nlm:aff id="AF0003">
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,
<addr-line>Hamilton, Montana</addr-line>
;</nlm:aff>
</affiliation>
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<author>
<name sortKey="Sims, Amy" sort="Sims, Amy" uniqKey="Sims A" first="Amy" last="Sims">Amy Sims</name>
<affiliation>
<nlm:aff id="AF0004">
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,
<addr-line>Chapel Hill, North Carolina</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Cockrell, Adam" sort="Cockrell, Adam" uniqKey="Cockrell A" first="Adam" last="Cockrell">Adam Cockrell</name>
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<nlm:aff id="AF0004">
<institution>Department of Epidemiology, University of North Carolina at Chapel Hill</institution>
,
<addr-line>Chapel Hill, North Carolina</addr-line>
;</nlm:aff>
</affiliation>
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<author>
<name sortKey="Feng, Joy" sort="Feng, Joy" uniqKey="Feng J" first="Joy" last="Feng">Joy Feng</name>
<affiliation>
<nlm:aff id="AF0001">
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,
<addr-line>Foster City, California</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Trantcheva, Iva" sort="Trantcheva, Iva" uniqKey="Trantcheva I" first="Iva" last="Trantcheva">Iva Trantcheva</name>
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<nlm:aff id="AF0001">
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,
<addr-line>Foster City, California</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Babusis, Darius" sort="Babusis, Darius" uniqKey="Babusis D" first="Darius" last="Babusis">Darius Babusis</name>
<affiliation>
<nlm:aff id="AF0001">
<institution>Gilead Sciences, Inc.</institution>
,
<addr-line>Foster City, California</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Porter Poulin, Danielle" sort="Porter Poulin, Danielle" uniqKey="Porter Poulin D" first="Danielle" last="Porter-Poulin">Danielle Porter-Poulin</name>
<affiliation>
<nlm:aff id="AF0001">
<institution>Gilead Sciences, Inc.</institution>
,
<addr-line>Foster City, California</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Bannister, Roy" sort="Bannister, Roy" uniqKey="Bannister R" first="Roy" last="Bannister">Roy Bannister</name>
<affiliation>
<nlm:aff id="AF0001">
<institution>Gilead Sciences, Inc.</institution>
,
<addr-line>Foster City, California</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Mackman, Richard" sort="Mackman, Richard" uniqKey="Mackman R" first="Richard" last="Mackman">Richard Mackman</name>
<affiliation>
<nlm:aff id="AF0001">
<institution>Gilead Sciences, Inc.</institution>
,
<addr-line>Foster City, California</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Siegel, Dustin" sort="Siegel, Dustin" uniqKey="Siegel D" first="Dustin" last="Siegel">Dustin Siegel</name>
<affiliation>
<nlm:aff id="AF0001">
<institution>Gilead Sciences, Inc.</institution>
,
<addr-line>Foster City, California</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Ray, Adrian" sort="Ray, Adrian" uniqKey="Ray A" first="Adrian" last="Ray">Adrian Ray</name>
<affiliation>
<nlm:aff id="AF0001">
<institution>Gilead Sciences, Inc.</institution>
,
<addr-line>Foster City, California</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Denison, Mark" sort="Denison, Mark" uniqKey="Denison M" first="Mark" last="Denison">Mark Denison</name>
<affiliation wicri:level="2">
<nlm:aff id="AF0006">
<institution>Pediatrics, Vanderbilt University Medical Center</institution>
,
<addr-line>Nashville, Tennessee</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Tennessee</region>
</placeName>
<wicri:cityArea>Nashville</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Spiropoulou, Christina" sort="Spiropoulou, Christina" uniqKey="Spiropoulou C" first="Christina" last="Spiropoulou">Christina Spiropoulou</name>
<affiliation>
<nlm:aff id="AF0005">
<institution>Centers for Disease Control and Prevention</institution>
,
<addr-line>Atlanta, Georgia</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Nichol, Stuart" sort="Nichol, Stuart" uniqKey="Nichol S" first="Stuart" last="Nichol">Stuart Nichol</name>
<affiliation>
<nlm:aff id="AF0005">
<institution>Centers for Disease Control and Prevention</institution>
,
<addr-line>Atlanta, Georgia</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Cihlar, Tomas" sort="Cihlar, Tomas" uniqKey="Cihlar T" first="Tomas" last="Cihlar">Tomas Cihlar</name>
<affiliation>
<nlm:aff id="AF0001">
<institution>Gilead Sciences, Inc.</institution>
,
<addr-line>Foster City, California</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Baric, Ralph" sort="Baric, Ralph" uniqKey="Baric R" first="Ralph" last="Baric">Ralph Baric</name>
<affiliation>
<nlm:aff id="AF0004">
<institution>Department of Epidemiology, University of North Carolina at Chapel Hill</institution>
,
<addr-line>Chapel Hill, North Carolina</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Feldmann, Heinrich" sort="Feldmann, Heinrich" uniqKey="Feldmann H" first="Heinrich" last="Feldmann">Heinrich Feldmann</name>
<affiliation>
<nlm:aff id="AF0003">
<institution>Laboratory of Virology, Division of Intramural Research, National Institute for Allergy and Infectious Diseases, National Institutes of Health, Rocky Mountain Laboratories</institution>
,
<addr-line>Hamilton, Montana</addr-line>
;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Bavari, Sina" sort="Bavari, Sina" uniqKey="Bavari S" first="Sina" last="Bavari">Sina Bavari</name>
<affiliation>
<nlm:aff id="AF0002">
<institution>United States Army Medical Research Institute of Infectious Diseases</institution>
,
<addr-line>Frederick, Maryland</addr-line>
;</nlm:aff>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Open Forum Infectious Diseases</title>
<idno type="eISSN">2328-8957</idno>
<imprint>
<date when="2017">2017</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc>
<textClass></textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">
<title>Abstract</title>
<sec id="s1">
<title>Background</title>
<p>Recent viral outbreaks with significant mortality such as Ebola virus (EBOV), SARS-coronavirus (CoV), and MERS-CoV reinforced the need for effective antiviral therapeutics to control future epidemics. GS-5734 is a novel nucleotide analog prodrug in the development for treatment of EBOV.</p>
</sec>
<sec id="s2">
<title>Method</title>
<p>Antiviral activity of GS-5734 has been established in vitro against a wide range of pathogenic RNA virus families, including filoviruses, coronaviruses, and paramyxoviruses (EC
<sub>50</sub>
 = 37 to 200 nM) (
<italic>Warren et al., Nature 2016; Sheahan et al., Sci Transl Med 2017; Lo et al., Sci Rep 2017</italic>
). Herein, we describe the in vivo translation of the broad-spectrum activity of GS-5734 in relevant animal disease models for Ebola, Marburg, MERS-CoV, and Nipah.</p>
</sec>
<sec id="s3">
<title>Result</title>
<p>Therapeutic efficacy against multiple filoviruses with 80–100% survival was observed in rhesus monkeys infected with lethal doses of EBOV (Kikwit/1995 or Makona/2014) or Marburg virus and treated with once daily intravenous (IV) administration of 5 to 10 mg/kg GS-5734 beginning 3 to 5 days post-infection (p.i.). In all rhesus monkey filovirus infection models, GS-5734 significantly reduced systemic viremia and ameliorated severe clinical disease signs and anatomic pathology. In mice infected with MERS-CoV, twice daily subcutaneous administration of 25 mg/kg GS-5734 beginning 1 day p.i. significantly reduced lung viral load and improved respiratory function. In rhesus monkeys, once-daily IV administration of 5 mg/kg GS-5734 initiated 1 day prior to MERS-CoV infection reduced lung viral load, improved clinical disease signs, and ameliorated severe lung pathology. Finally, in African green monkeys infected with a lethal dose of Nipah virus therapeutic once-daily IV administration of 10 mg/kg GS-5734, starting 1 day p.i. resulted in 100% survival to at least day 35 without any major respiratory or CNS symptoms.</p>
</sec>
<sec id="s4">
<title>Conclusion</title>
<p>GS-5734 is currently being tested in a phase 2 study in male Ebola survivors with persistent viral RNA in semen. Lyophilized drug formulation has been developed that can be administered to humans via a 30-minutes IV infusion and does not require cold chain storage. Together, these results support further development of GS-5734 as a broad-spectrum antiviral to treat viral infections with high mortality and significant outbreak potential.</p>
</sec>
<sec id="s5">
<title>Disclosures</title>
<p>
<bold>R. Jordan</bold>
, Gilead: Employee, Salary.
<bold>J. Feng</bold>
, Gilead: Employee, Salary</p>
<p>
<bold>I. Trantcheva</bold>
, Gilead: Employee, Salary.
<bold>D. Babusis</bold>
, Gilead: Employee, Salary.
<bold>D. Porter-Poulin</bold>
, Gilead: Employee, Salary.
<bold>R. Bannister</bold>
, Gilead: Employee, Salary</p>
<p>
<bold>R. Mackman</bold>
, Gilead: Employee, Salary.
<bold>D. Siegel</bold>
, Gilead: Employee, Salary</p>
<p>
<bold>A. Ray</bold>
, Gilead: Employee, Salary,
<bold>T. Cihlar</bold>
, Gilead: Employee, Salary.</p>
</sec>
</div>
</front>
</TEI>
<pmc article-type="abstract">
<pmc-dir>properties open_access</pmc-dir>
<front>
<journal-meta>
<journal-id journal-id-type="nlm-ta">Open Forum Infect Dis</journal-id>
<journal-id journal-id-type="iso-abbrev">Open Forum Infect Dis</journal-id>
<journal-id journal-id-type="publisher-id">ofid</journal-id>
<journal-title-group>
<journal-title>Open Forum Infectious Diseases</journal-title>
</journal-title-group>
<issn pub-type="epub">2328-8957</issn>
<publisher>
<publisher-name>Oxford University Press</publisher-name>
<publisher-loc>US</publisher-loc>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="pmc">5630887</article-id>
<article-id pub-id-type="doi">10.1093/ofid/ofx180.008</article-id>
<article-id pub-id-type="publisher-id">ofx180.008</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Abstracts</subject>
<subj-group subj-group-type="category-toc-heading">
<subject>Late Breaker Abstract</subject>
</subj-group>
</subj-group>
</article-categories>
<title-group>
<article-title>Broad-spectrum Investigational Agent GS-5734 for the Treatment of Ebola, MERS Coronavirus and Other Pathogenic Viral Infections with High Outbreak Potential</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname>Jordan</surname>
<given-names>Robert</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0001">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Hogg</surname>
<given-names>Alison</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0001">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Warren</surname>
<given-names>Travis</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0002">2</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>De Wit</surname>
<given-names>Emmie</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0003">3</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Sheahan</surname>
<given-names>Timothy</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0004">4</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Lo</surname>
<given-names>Michael</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0005">5</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Soloveva</surname>
<given-names>Veronica</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0002">2</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Weidner</surname>
<given-names>Jessica</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0002">2</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Gomba</surname>
<given-names>Laura</given-names>
</name>
<degrees>MBA</degrees>
<xref ref-type="aff" rid="AF0002">2</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Feldmann</surname>
<given-names>Friederike</given-names>
</name>
<degrees>BS</degrees>
<xref ref-type="aff" rid="AF0003">3</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Cronin</surname>
<given-names>Jacqueline</given-names>
</name>
<degrees>BS</degrees>
<xref ref-type="aff" rid="AF0003">3</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Sims</surname>
<given-names>Amy</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0004">4</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Cockrell</surname>
<given-names>Adam</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0004">4</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Feng</surname>
<given-names>Joy</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0001">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Trantcheva</surname>
<given-names>Iva</given-names>
</name>
<degrees>FPD</degrees>
<xref ref-type="aff" rid="AF0001">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Babusis</surname>
<given-names>Darius</given-names>
</name>
<degrees>MS</degrees>
<xref ref-type="aff" rid="AF0001">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Porter-Poulin</surname>
<given-names>Danielle</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0001">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Bannister</surname>
<given-names>Roy</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0001">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Mackman</surname>
<given-names>Richard</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0001">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Siegel</surname>
<given-names>Dustin</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0001">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Ray</surname>
<given-names>Adrian</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0001">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Denison</surname>
<given-names>Mark</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="AF0006">6</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Spiropoulou</surname>
<given-names>Christina</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0005">5</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Nichol</surname>
<given-names>Stuart</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0005">5</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Cihlar</surname>
<given-names>Tomas</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0001">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Baric</surname>
<given-names>Ralph</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0004">4</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Feldmann</surname>
<given-names>Heinrich</given-names>
</name>
<degrees>MD, PhD</degrees>
<xref ref-type="aff" rid="AF0003">3</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Bavari</surname>
<given-names>Sina</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="AF0002">2</xref>
</contrib>
</contrib-group>
<aff id="AF0001">
<label>1</label>
<institution>Gilead Sciences, Inc.</institution>
,
<addr-line>Foster City, California</addr-line>
;</aff>
<aff id="AF0002">
<label>2</label>
<institution>United States Army Medical Research Institute of Infectious Diseases</institution>
,
<addr-line>Frederick, Maryland</addr-line>
;</aff>
<aff id="AF0003">
<label>3</label>
<institution>Laboratory of Virology, Division of Intramural Research, National Institute for Allergy and Infectious Diseases, National Institutes of Health, Rocky Mountain Laboratories</institution>
,
<addr-line>Hamilton, Montana</addr-line>
;</aff>
<aff id="AF0004">
<label>4</label>
<institution>Department of Epidemiology, University of North Carolina at Chapel Hill</institution>
,
<addr-line>Chapel Hill, North Carolina</addr-line>
;</aff>
<aff id="AF0005">
<label>5</label>
<institution>Centers for Disease Control and Prevention</institution>
,
<addr-line>Atlanta, Georgia</addr-line>
;</aff>
<aff id="AF0006">
<label>6</label>
<institution>Pediatrics, Vanderbilt University Medical Center</institution>
,
<addr-line>Nashville, Tennessee</addr-line>
</aff>
<author-notes>
<fn id="fn-0001">
<p>
<bold>Session:</bold>
228. Late Breaker Oral Abstracts</p>
<p>
<italic>Saturday, October 7, 2017: 10:30 AM</italic>
</p>
</fn>
</author-notes>
<pub-date pub-type="collection">
<season>Fall</season>
<year>2017</year>
</pub-date>
<pub-date pub-type="epub" iso-8601-date="2017-10-04">
<day>04</day>
<month>10</month>
<year>2017</year>
</pub-date>
<pub-date pub-type="pmc-release">
<day>04</day>
<month>10</month>
<year>2017</year>
</pub-date>
<pmc-comment> PMC Release delay is 0 months and 0 days and was based on the . </pmc-comment>
<volume>4</volume>
<issue>Suppl 1</issue>
<issue-title>ID Week 2017 Abstracts</issue-title>
<fpage>S737</fpage>
<lpage>S737</lpage>
<permissions>
<copyright-statement>© The Author 2017. Published by Oxford University Press on behalf of Infectious Diseases Society of America.</copyright-statement>
<copyright-year>2017</copyright-year>
<license license-type="cc-by-nc-nd" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0">
<license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (
<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0/">http://creativecommons.org/licenses/by-nc-nd/4.0/</ext-link>
), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com</license-p>
</license>
</permissions>
<self-uri xlink:href="ofx180.008.pdf"></self-uri>
<abstract>
<title>Abstract</title>
<sec id="s1">
<title>Background</title>
<p>Recent viral outbreaks with significant mortality such as Ebola virus (EBOV), SARS-coronavirus (CoV), and MERS-CoV reinforced the need for effective antiviral therapeutics to control future epidemics. GS-5734 is a novel nucleotide analog prodrug in the development for treatment of EBOV.</p>
</sec>
<sec id="s2">
<title>Method</title>
<p>Antiviral activity of GS-5734 has been established in vitro against a wide range of pathogenic RNA virus families, including filoviruses, coronaviruses, and paramyxoviruses (EC
<sub>50</sub>
 = 37 to 200 nM) (
<italic>Warren et al., Nature 2016; Sheahan et al., Sci Transl Med 2017; Lo et al., Sci Rep 2017</italic>
). Herein, we describe the in vivo translation of the broad-spectrum activity of GS-5734 in relevant animal disease models for Ebola, Marburg, MERS-CoV, and Nipah.</p>
</sec>
<sec id="s3">
<title>Result</title>
<p>Therapeutic efficacy against multiple filoviruses with 80–100% survival was observed in rhesus monkeys infected with lethal doses of EBOV (Kikwit/1995 or Makona/2014) or Marburg virus and treated with once daily intravenous (IV) administration of 5 to 10 mg/kg GS-5734 beginning 3 to 5 days post-infection (p.i.). In all rhesus monkey filovirus infection models, GS-5734 significantly reduced systemic viremia and ameliorated severe clinical disease signs and anatomic pathology. In mice infected with MERS-CoV, twice daily subcutaneous administration of 25 mg/kg GS-5734 beginning 1 day p.i. significantly reduced lung viral load and improved respiratory function. In rhesus monkeys, once-daily IV administration of 5 mg/kg GS-5734 initiated 1 day prior to MERS-CoV infection reduced lung viral load, improved clinical disease signs, and ameliorated severe lung pathology. Finally, in African green monkeys infected with a lethal dose of Nipah virus therapeutic once-daily IV administration of 10 mg/kg GS-5734, starting 1 day p.i. resulted in 100% survival to at least day 35 without any major respiratory or CNS symptoms.</p>
</sec>
<sec id="s4">
<title>Conclusion</title>
<p>GS-5734 is currently being tested in a phase 2 study in male Ebola survivors with persistent viral RNA in semen. Lyophilized drug formulation has been developed that can be administered to humans via a 30-minutes IV infusion and does not require cold chain storage. Together, these results support further development of GS-5734 as a broad-spectrum antiviral to treat viral infections with high mortality and significant outbreak potential.</p>
</sec>
<sec id="s5">
<title>Disclosures</title>
<p>
<bold>R. Jordan</bold>
, Gilead: Employee, Salary.
<bold>J. Feng</bold>
, Gilead: Employee, Salary</p>
<p>
<bold>I. Trantcheva</bold>
, Gilead: Employee, Salary.
<bold>D. Babusis</bold>
, Gilead: Employee, Salary.
<bold>D. Porter-Poulin</bold>
, Gilead: Employee, Salary.
<bold>R. Bannister</bold>
, Gilead: Employee, Salary</p>
<p>
<bold>R. Mackman</bold>
, Gilead: Employee, Salary.
<bold>D. Siegel</bold>
, Gilead: Employee, Salary</p>
<p>
<bold>A. Ray</bold>
, Gilead: Employee, Salary,
<bold>T. Cihlar</bold>
, Gilead: Employee, Salary.</p>
</sec>
</abstract>
<counts>
<page-count count="1"></page-count>
</counts>
</article-meta>
</front>
</pmc>
<affiliations>
<list>
<country>
<li>États-Unis</li>
</country>
<region>
<li>Tennessee</li>
</region>
</list>
<tree>
<noCountry>
<name sortKey="Babusis, Darius" sort="Babusis, Darius" uniqKey="Babusis D" first="Darius" last="Babusis">Darius Babusis</name>
<name sortKey="Bannister, Roy" sort="Bannister, Roy" uniqKey="Bannister R" first="Roy" last="Bannister">Roy Bannister</name>
<name sortKey="Baric, Ralph" sort="Baric, Ralph" uniqKey="Baric R" first="Ralph" last="Baric">Ralph Baric</name>
<name sortKey="Bavari, Sina" sort="Bavari, Sina" uniqKey="Bavari S" first="Sina" last="Bavari">Sina Bavari</name>
<name sortKey="Cihlar, Tomas" sort="Cihlar, Tomas" uniqKey="Cihlar T" first="Tomas" last="Cihlar">Tomas Cihlar</name>
<name sortKey="Cockrell, Adam" sort="Cockrell, Adam" uniqKey="Cockrell A" first="Adam" last="Cockrell">Adam Cockrell</name>
<name sortKey="Cronin, Jacqueline" sort="Cronin, Jacqueline" uniqKey="Cronin J" first="Jacqueline" last="Cronin">Jacqueline Cronin</name>
<name sortKey="De Wit, Emmie" sort="De Wit, Emmie" uniqKey="De Wit E" first="Emmie" last="De Wit">Emmie De Wit</name>
<name sortKey="Feldmann, Friederike" sort="Feldmann, Friederike" uniqKey="Feldmann F" first="Friederike" last="Feldmann">Friederike Feldmann</name>
<name sortKey="Feldmann, Heinrich" sort="Feldmann, Heinrich" uniqKey="Feldmann H" first="Heinrich" last="Feldmann">Heinrich Feldmann</name>
<name sortKey="Feng, Joy" sort="Feng, Joy" uniqKey="Feng J" first="Joy" last="Feng">Joy Feng</name>
<name sortKey="Gomba, Laura" sort="Gomba, Laura" uniqKey="Gomba L" first="Laura" last="Gomba">Laura Gomba</name>
<name sortKey="Hogg, Alison" sort="Hogg, Alison" uniqKey="Hogg A" first="Alison" last="Hogg">Alison Hogg</name>
<name sortKey="Jordan, Robert" sort="Jordan, Robert" uniqKey="Jordan R" first="Robert" last="Jordan">Robert Jordan</name>
<name sortKey="Lo, Michael" sort="Lo, Michael" uniqKey="Lo M" first="Michael" last="Lo">Michael Lo</name>
<name sortKey="Mackman, Richard" sort="Mackman, Richard" uniqKey="Mackman R" first="Richard" last="Mackman">Richard Mackman</name>
<name sortKey="Nichol, Stuart" sort="Nichol, Stuart" uniqKey="Nichol S" first="Stuart" last="Nichol">Stuart Nichol</name>
<name sortKey="Porter Poulin, Danielle" sort="Porter Poulin, Danielle" uniqKey="Porter Poulin D" first="Danielle" last="Porter-Poulin">Danielle Porter-Poulin</name>
<name sortKey="Ray, Adrian" sort="Ray, Adrian" uniqKey="Ray A" first="Adrian" last="Ray">Adrian Ray</name>
<name sortKey="Sheahan, Timothy" sort="Sheahan, Timothy" uniqKey="Sheahan T" first="Timothy" last="Sheahan">Timothy Sheahan</name>
<name sortKey="Siegel, Dustin" sort="Siegel, Dustin" uniqKey="Siegel D" first="Dustin" last="Siegel">Dustin Siegel</name>
<name sortKey="Sims, Amy" sort="Sims, Amy" uniqKey="Sims A" first="Amy" last="Sims">Amy Sims</name>
<name sortKey="Soloveva, Veronica" sort="Soloveva, Veronica" uniqKey="Soloveva V" first="Veronica" last="Soloveva">Veronica Soloveva</name>
<name sortKey="Spiropoulou, Christina" sort="Spiropoulou, Christina" uniqKey="Spiropoulou C" first="Christina" last="Spiropoulou">Christina Spiropoulou</name>
<name sortKey="Trantcheva, Iva" sort="Trantcheva, Iva" uniqKey="Trantcheva I" first="Iva" last="Trantcheva">Iva Trantcheva</name>
<name sortKey="Warren, Travis" sort="Warren, Travis" uniqKey="Warren T" first="Travis" last="Warren">Travis Warren</name>
<name sortKey="Weidner, Jessica" sort="Weidner, Jessica" uniqKey="Weidner J" first="Jessica" last="Weidner">Jessica Weidner</name>
</noCountry>
<country name="États-Unis">
<region name="Tennessee">
<name sortKey="Denison, Mark" sort="Denison, Mark" uniqKey="Denison M" first="Mark" last="Denison">Mark Denison</name>
</region>
</country>
</tree>
</affiliations>
</record>

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{{Explor lien
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Pour générer des pages wiki

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Data generation: Tue Apr 28 14:49:16 2020. Site generation: Sat Mar 27 22:06:49 2021