Grazoprevir, ruzasvir, and uprifosbuvir for hepatitis C virus after NS5A treatment failure.
Identifieur interne : 000955 ( PubMed/Curation ); précédent : 000954; suivant : 000956Grazoprevir, 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.
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
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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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<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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<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
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<author><name sortKey="Robertson, Michael" sort="Robertson, Michael" uniqKey="Robertson M" first="Michael" last="Robertson">Michael Robertson</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>
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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="Barr, Eliav" sort="Barr, Eliav" uniqKey="Barr E" first="Eliav" last="Barr">Eliav Barr</name>
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<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
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<wicri:cityArea>Merck & Co., Inc., Kenilworth</wicri:cityArea>
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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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<author><name sortKey="Serfaty, Lawrence" sort="Serfaty, Lawrence" uniqKey="Serfaty L" first="Lawrence" last="Serfaty">Lawrence Serfaty</name>
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<country xml:lang="fr">France</country>
<wicri:regionArea>Service d'Hépatologie, Hôpital Saint-Antoine, Université Pierre & Marie Curie, Paris</wicri:regionArea>
</affiliation>
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<series><title level="j">Hepatology (Baltimore, Md.)</title>
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<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>
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<pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">28688129</PMID>
<DateCreated><Year>2017</Year>
<Month>07</Month>
<Day>08</Day>
</DateCreated>
<DateRevised><Year>2017</Year>
<Month>10</Month>
<Day>30</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1527-3350</ISSN>
<JournalIssue CitedMedium="Internet"><PubDate><Year>2017</Year>
<Month>Jul</Month>
<Day>07</Day>
</PubDate>
</JournalIssue>
<Title>Hepatology (Baltimore, Md.)</Title>
<ISOAbbreviation>Hepatology</ISOAbbreviation>
</Journal>
<ArticleTitle>Grazoprevir, ruzasvir, and uprifosbuvir for hepatitis C virus after NS5A treatment failure.</ArticleTitle>
<ELocationID EIdType="doi" ValidYN="Y">10.1002/hep.29358</ELocationID>
<Abstract><AbstractText>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.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Grazoprevir, ruzasvir, and uprifosbuvir, with or without ribavirin, for 16 or 24 weeks was safe and highly effective in participants with HCV infection who had previously failed NS5A inhibitor-containing therapy. (Hepatology 2017).</AbstractText>
<CopyrightInformation>© 2017 by the American Association for the Study of Liver Diseases.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Wyles</LastName>
<ForeName>David</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>University of Colorado School of Medicine, Denver, CO.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wedemeyer</LastName>
<ForeName>Heiner</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ben-Ari</LastName>
<ForeName>Ziv</ForeName>
<Initials>Z</Initials>
<AffiliationInfo><Affiliation>Sheba Medical Center, Tel Hashomer, Israel.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gane</LastName>
<ForeName>Edward J</ForeName>
<Initials>EJ</Initials>
<AffiliationInfo><Affiliation>Auckland Hospital, Auckland, New Zealand.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hansen</LastName>
<ForeName>Jesper Bach</ForeName>
<Initials>JB</Initials>
<AffiliationInfo><Affiliation>Aalborg University Hospital, Department of Gastroenterology, Aalborg, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Jacobson</LastName>
<ForeName>Ira M</ForeName>
<Initials>IM</Initials>
<AffiliationInfo><Affiliation>Mount Sinai Beth Israel and Icahn School of Medicine at Mount Sinai, New York, NY.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Laursen</LastName>
<ForeName>Alex L</ForeName>
<Initials>AL</Initials>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, Aarhus University Hospital, Skejby, Aarhus, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Luetkemeyer</LastName>
<ForeName>Annie</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Nahass</LastName>
<ForeName>Ronald</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>ID Care, Hillsborough, NJ.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pianko</LastName>
<ForeName>Stephen</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Monash Medical Centre, Clayton, Victoria, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Zeuzem</LastName>
<ForeName>Stefan</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Goethe University Hospital, Frankfurt, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Jumes</LastName>
<ForeName>Patricia</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Merck & Co., Inc., Kenilworth, NJ.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Huang</LastName>
<ForeName>Hsueh-Cheng</ForeName>
<Initials>HC</Initials>
<AffiliationInfo><Affiliation>Merck & Co., Inc., Kenilworth, NJ.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Butterton</LastName>
<ForeName>Joan</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Merck & Co., Inc., Kenilworth, NJ.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Robertson</LastName>
<ForeName>Michael</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Merck & Co., Inc., Kenilworth, NJ.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wahl</LastName>
<ForeName>Janice</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Merck & Co., Inc., Kenilworth, NJ.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Barr</LastName>
<ForeName>Eliav</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Merck & Co., Inc., Kenilworth, NJ.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Joeng</LastName>
<ForeName>Hee-Koung</ForeName>
<Initials>HK</Initials>
<AffiliationInfo><Affiliation>Merck & Co., Inc., Kenilworth, NJ.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Martin</LastName>
<ForeName>Elizabeth</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Merck & Co., Inc., Kenilworth, NJ.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Serfaty</LastName>
<ForeName>Lawrence</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Service d'Hépatologie, Hôpital Saint-Antoine, Université Pierre & Marie Curie, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><CollectiveName>C-CREST Part C and C-SURGE Investigators</CollectiveName>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2017</Year>
<Month>07</Month>
<Day>07</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>Hepatology</MedlineTA>
<NlmUniqueID>8302946</NlmUniqueID>
<ISSNLinking>0270-9139</ISSNLinking>
</MedlineJournalInfo>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year>
<Month>05</Month>
<Day>01</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised"><Year>2017</Year>
<Month>06</Month>
<Day>05</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2017</Year>
<Month>07</Month>
<Day>06</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2017</Year>
<Month>7</Month>
<Day>9</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2017</Year>
<Month>7</Month>
<Day>9</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2017</Year>
<Month>7</Month>
<Day>9</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>aheadofprint</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">28688129</ArticleId>
<ArticleId IdType="doi">10.1002/hep.29358</ArticleId>
</ArticleIdList>
</PubmedData>
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