AustralieFrV1, Main, Exploration, bibRecord, 000B26

Grazoprevir, ruzasvir, and uprifosbuvir for hepatitis C virus after NS5A treatment failure.

Identifieur interne : 000B26 ( Main/Exploration ); précédent : 000B25; suivant : 000B27

Grazoprevir, ruzasvir, and uprifosbuvir for hepatitis C virus after NS5A treatment failure.

Auteurs : David Wyles [États-Unis] ; Heiner Wedemeyer [Allemagne] ; Ziv Ben-Ari [Israël] ; Edward J. Gane [Nouvelle-Zélande] ; Jesper Bach Hansen [Danemark] ; Ira M. Jacobson [États-Unis] ; Alex L. Laursen [Danemark] ; Annie Luetkemeyer [États-Unis] ; Ronald Nahass [États-Unis] ; Stephen Pianko [Australie] ; Stefan Zeuzem [Allemagne] ; Patricia Jumes [États-Unis] ; Hsueh-Cheng Huang [États-Unis] ; Joan Butterton [États-Unis] ; Michael Robertson [États-Unis] ; Janice Wahl [États-Unis] ; Eliav Barr [États-Unis] ; Hee-Koung Joeng [États-Unis] ; Elizabeth Martin [États-Unis] ; Lawrence Serfaty [France]

Source :

Hepatology (Baltimore, Md.) [ 1527-3350 ] ; 2017.

RBID : pubmed:28688129

Abstract

People with hepatitis C virus (HCV) infection who have failed treatment with an all-oral regimen represent a challenging treatment population. The present studies evaluated the safety and efficacy of grazoprevir, ruzasvir, and uprifosbuvir, with or without ribavirin, in participants who had failed an NS5A inhibitor-containing regimen. C-SURGE (PN-3682-021) and C-CREST Part C (PN-3682-011 and -012) were open-label, multicenter studies. Participants who had previously relapsed following an NS5A inhibitor-containing all-oral regimen were retreated with grazoprevir 100 mg, ruzasvir 60 mg, and uprifosbuvir 450 mg alone for 24 weeks or with ribavirin for 16 weeks. The primary efficacy endpoint was sustained virologic response (HCV RNA below the limit of quantitation [<15 IU/mL]) 12 weeks after treatment completion (SVR12). In C-SURGE, SVR12 was achieved by 49/49 (100%) and 43/44 (98%) genotype (GT)1 participants in the 24-week no ribavirin arm and the 16-week plus ribavirin arm (lost to follow-up, n = 1), respectively. In C-CREST Part C, SVR12 was achieved by 23/24 (96%) participants treated for 16 weeks with ribavirin (GT1, 2/2 [100%]; GT2, 13/14 [93%]; GT3, 8/8 [100%]). One participant with GT2 infection discontinued study medication after a single dose of grazoprevir, ruzasvir, and uprifosbuvir plus ribavirin due to serious adverse events of vomiting and tachycardia. The presence of baseline resistance-associated substitutions had no impact on SVR12. No participant who completed treatment in either study experienced virologic failure.

DOI: 10.1002/hep.29358
PubMed: 28688129

Affiliations:

Le document en format XML

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<author><name sortKey="Nahass, Ronald" sort="Nahass, Ronald" uniqKey="Nahass R" first="Ronald" last="Nahass">Ronald Nahass</name>
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<author><name sortKey="Pianko, Stephen" sort="Pianko, Stephen" uniqKey="Pianko S" first="Stephen" last="Pianko">Stephen Pianko</name>
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<author><name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name>
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<author><name sortKey="Huang, Hsueh Cheng" sort="Huang, Hsueh Cheng" uniqKey="Huang H" first="Hsueh-Cheng" last="Huang">Hsueh-Cheng Huang</name>
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<author><name sortKey="Butterton, Joan" sort="Butterton, Joan" uniqKey="Butterton J" first="Joan" last="Butterton">Joan Butterton</name>
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<author><name sortKey="Robertson, Michael" sort="Robertson, Michael" uniqKey="Robertson M" first="Michael" last="Robertson">Michael Robertson</name>
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<author><name sortKey="Wahl, Janice" sort="Wahl, Janice" uniqKey="Wahl J" first="Janice" last="Wahl">Janice Wahl</name>
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<author><name sortKey="Joeng, Hee Koung" sort="Joeng, Hee Koung" uniqKey="Joeng H" first="Hee-Koung" last="Joeng">Hee-Koung Joeng</name>
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<author><name sortKey="Martin, Elizabeth" sort="Martin, Elizabeth" uniqKey="Martin E" first="Elizabeth" last="Martin">Elizabeth Martin</name>
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<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
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<author><name sortKey="Serfaty, Lawrence" sort="Serfaty, Lawrence" uniqKey="Serfaty L" first="Lawrence" last="Serfaty">Lawrence Serfaty</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Grazoprevir, ruzasvir, and uprifosbuvir for hepatitis C virus after NS5A treatment failure.</title>
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<author><name sortKey="Wedemeyer, Heiner" sort="Wedemeyer, Heiner" uniqKey="Wedemeyer H" first="Heiner" last="Wedemeyer">Heiner Wedemeyer</name>
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<country xml:lang="fr">Allemagne</country>
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<author><name sortKey="Gane, Edward J" sort="Gane, Edward J" uniqKey="Gane E" first="Edward J" last="Gane">Edward J. Gane</name>
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<country xml:lang="fr">Nouvelle-Zélande</country>
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<author><name sortKey="Hansen, Jesper Bach" sort="Hansen, Jesper Bach" uniqKey="Hansen J" first="Jesper Bach" last="Hansen">Jesper Bach Hansen</name>
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<country xml:lang="fr">Danemark</country>
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<author><name sortKey="Jacobson, Ira M" sort="Jacobson, Ira M" uniqKey="Jacobson I" first="Ira M" last="Jacobson">Ira M. Jacobson</name>
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<author><name sortKey="Laursen, Alex L" sort="Laursen, Alex L" uniqKey="Laursen A" first="Alex L" last="Laursen">Alex L. Laursen</name>
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<author><name sortKey="Luetkemeyer, Annie" sort="Luetkemeyer, Annie" uniqKey="Luetkemeyer A" first="Annie" last="Luetkemeyer">Annie Luetkemeyer</name>
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<author><name sortKey="Nahass, Ronald" sort="Nahass, Ronald" uniqKey="Nahass R" first="Ronald" last="Nahass">Ronald Nahass</name>
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<author><name sortKey="Pianko, Stephen" sort="Pianko, Stephen" uniqKey="Pianko S" first="Stephen" last="Pianko">Stephen Pianko</name>
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<author><name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name>
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<wicri:regionArea>Goethe University Hospital, Frankfurt</wicri:regionArea>
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<author><name sortKey="Jumes, Patricia" sort="Jumes, Patricia" uniqKey="Jumes P" first="Patricia" last="Jumes">Patricia Jumes</name>
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<author><name sortKey="Huang, Hsueh Cheng" sort="Huang, Hsueh Cheng" uniqKey="Huang H" first="Hsueh-Cheng" last="Huang">Hsueh-Cheng Huang</name>
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<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
</placeName>
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<author><name sortKey="Butterton, Joan" sort="Butterton, Joan" uniqKey="Butterton J" first="Joan" last="Butterton">Joan Butterton</name>
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<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Merck & Co., Inc., Kenilworth</wicri:cityArea>
</affiliation>
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<author><name sortKey="Robertson, Michael" sort="Robertson, Michael" uniqKey="Robertson M" first="Michael" last="Robertson">Michael Robertson</name>
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<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Merck & Co., Inc., Kenilworth</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Wahl, Janice" sort="Wahl, Janice" uniqKey="Wahl J" first="Janice" last="Wahl">Janice Wahl</name>
<affiliation wicri:level="2"><nlm:affiliation>Merck & Co., Inc., Kenilworth, NJ.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Merck & Co., Inc., Kenilworth</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Barr, Eliav" sort="Barr, Eliav" uniqKey="Barr E" first="Eliav" last="Barr">Eliav Barr</name>
<affiliation wicri:level="2"><nlm:affiliation>Merck & Co., Inc., Kenilworth, NJ.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Merck & Co., Inc., Kenilworth</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Joeng, Hee Koung" sort="Joeng, Hee Koung" uniqKey="Joeng H" first="Hee-Koung" last="Joeng">Hee-Koung Joeng</name>
<affiliation wicri:level="2"><nlm:affiliation>Merck & Co., Inc., Kenilworth, NJ.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Merck & Co., Inc., Kenilworth</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Martin, Elizabeth" sort="Martin, Elizabeth" uniqKey="Martin E" first="Elizabeth" last="Martin">Elizabeth Martin</name>
<affiliation wicri:level="2"><nlm:affiliation>Merck & Co., Inc., Kenilworth, NJ.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Merck & Co., Inc., Kenilworth</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Serfaty, Lawrence" sort="Serfaty, Lawrence" uniqKey="Serfaty L" first="Lawrence" last="Serfaty">Lawrence Serfaty</name>
<affiliation wicri:level="3"><nlm:affiliation>Service d'Hépatologie, Hôpital Saint-Antoine, Université Pierre & Marie Curie, Paris, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Service d'Hépatologie, Hôpital Saint-Antoine, Université Pierre & Marie Curie, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">Hepatology (Baltimore, Md.)</title>
<idno type="eISSN">1527-3350</idno>
<imprint><date when="2017" type="published">2017</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">People with hepatitis C virus (HCV) infection who have failed treatment with an all-oral regimen represent a challenging treatment population. The present studies evaluated the safety and efficacy of grazoprevir, ruzasvir, and uprifosbuvir, with or without ribavirin, in participants who had failed an NS5A inhibitor-containing regimen. C-SURGE (PN-3682-021) and C-CREST Part C (PN-3682-011 and -012) were open-label, multicenter studies. Participants who had previously relapsed following an NS5A inhibitor-containing all-oral regimen were retreated with grazoprevir 100 mg, ruzasvir 60 mg, and uprifosbuvir 450 mg alone for 24 weeks or with ribavirin for 16 weeks. The primary efficacy endpoint was sustained virologic response (HCV RNA below the limit of quantitation [<15 IU/mL]) 12 weeks after treatment completion (SVR12). In C-SURGE, SVR12 was achieved by 49/49 (100%) and 43/44 (98%) genotype (GT)1 participants in the 24-week no ribavirin arm and the 16-week plus ribavirin arm (lost to follow-up, n = 1), respectively. In C-CREST Part C, SVR12 was achieved by 23/24 (96%) participants treated for 16 weeks with ribavirin (GT1, 2/2 [100%]; GT2, 13/14 [93%]; GT3, 8/8 [100%]). One participant with GT2 infection discontinued study medication after a single dose of grazoprevir, ruzasvir, and uprifosbuvir plus ribavirin due to serious adverse events of vomiting and tachycardia. The presence of baseline resistance-associated substitutions had no impact on SVR12. No participant who completed treatment in either study experienced virologic failure.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Danemark</li>
<li>France</li>
<li>Israël</li>
<li>Nouvelle-Zélande</li>
<li>États-Unis</li>
</country>
<region><li>Basse-Saxe</li>
<li>Californie</li>
<li>Colorado</li>
<li>District de Darmstadt</li>
<li>Hesse (Land)</li>
<li>New Jersey</li>
<li>État de New York</li>
<li>Île-de-France</li>
</region>
<settlement><li>Francfort-sur-le-Main</li>
<li>Hanovre</li>
<li>Paris</li>
</settlement>
</list>
<tree><country name="États-Unis"><region name="Colorado"><name sortKey="Wyles, David" sort="Wyles, David" uniqKey="Wyles D" first="David" last="Wyles">David Wyles</name>
</region>
<name sortKey="Barr, Eliav" sort="Barr, Eliav" uniqKey="Barr E" first="Eliav" last="Barr">Eliav Barr</name>
<name sortKey="Butterton, Joan" sort="Butterton, Joan" uniqKey="Butterton J" first="Joan" last="Butterton">Joan Butterton</name>
<name sortKey="Huang, Hsueh Cheng" sort="Huang, Hsueh Cheng" uniqKey="Huang H" first="Hsueh-Cheng" last="Huang">Hsueh-Cheng Huang</name>
<name sortKey="Jacobson, Ira M" sort="Jacobson, Ira M" uniqKey="Jacobson I" first="Ira M" last="Jacobson">Ira M. Jacobson</name>
<name sortKey="Joeng, Hee Koung" sort="Joeng, Hee Koung" uniqKey="Joeng H" first="Hee-Koung" last="Joeng">Hee-Koung Joeng</name>
<name sortKey="Jumes, Patricia" sort="Jumes, Patricia" uniqKey="Jumes P" first="Patricia" last="Jumes">Patricia Jumes</name>
<name sortKey="Luetkemeyer, Annie" sort="Luetkemeyer, Annie" uniqKey="Luetkemeyer A" first="Annie" last="Luetkemeyer">Annie Luetkemeyer</name>
<name sortKey="Martin, Elizabeth" sort="Martin, Elizabeth" uniqKey="Martin E" first="Elizabeth" last="Martin">Elizabeth Martin</name>
<name sortKey="Nahass, Ronald" sort="Nahass, Ronald" uniqKey="Nahass R" first="Ronald" last="Nahass">Ronald Nahass</name>
<name sortKey="Robertson, Michael" sort="Robertson, Michael" uniqKey="Robertson M" first="Michael" last="Robertson">Michael Robertson</name>
<name sortKey="Wahl, Janice" sort="Wahl, Janice" uniqKey="Wahl J" first="Janice" last="Wahl">Janice Wahl</name>
</country>
<country name="Allemagne"><region name="Basse-Saxe"><name sortKey="Wedemeyer, Heiner" sort="Wedemeyer, Heiner" uniqKey="Wedemeyer H" first="Heiner" last="Wedemeyer">Heiner Wedemeyer</name>
</region>
<name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name>
</country>
<country name="Israël"><noRegion><name sortKey="Ben Ari, Ziv" sort="Ben Ari, Ziv" uniqKey="Ben Ari Z" first="Ziv" last="Ben-Ari">Ziv Ben-Ari</name>
</noRegion>
</country>
<country name="Nouvelle-Zélande"><noRegion><name sortKey="Gane, Edward J" sort="Gane, Edward J" uniqKey="Gane E" first="Edward J" last="Gane">Edward J. Gane</name>
</noRegion>
</country>
<country name="Danemark"><noRegion><name sortKey="Hansen, Jesper Bach" sort="Hansen, Jesper Bach" uniqKey="Hansen J" first="Jesper Bach" last="Hansen">Jesper Bach Hansen</name>
</noRegion>
<name sortKey="Laursen, Alex L" sort="Laursen, Alex L" uniqKey="Laursen A" first="Alex L" last="Laursen">Alex L. Laursen</name>
</country>
<country name="Australie"><noRegion><name sortKey="Pianko, Stephen" sort="Pianko, Stephen" uniqKey="Pianko S" first="Stephen" last="Pianko">Stephen Pianko</name>
</noRegion>
</country>
<country name="France"><region name="Île-de-France"><name sortKey="Serfaty, Lawrence" sort="Serfaty, Lawrence" uniqKey="Serfaty L" first="Lawrence" last="Serfaty">Lawrence Serfaty</name>
</region>
</country>
</tree>
</affiliations>
</record>

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Grazoprevir, ruzasvir, and uprifosbuvir for hepatitis C virus after NS5A treatment failure.

Grazoprevir, ruzasvir, and uprifosbuvir for hepatitis C virus after NS5A treatment failure.

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