Ontology type: schema:ScholarlyArticle
2019-03-13
AUTHORSAtsushi Naganuma, Kazuaki Chayama, Kazuo Notsumata, Edward Gane, Graham R. Foster, David Wyles, Paul Kwo, Eric Crown, Abhi Bhagat, Federico J. Mensa, Tetsuya Otani, Lois Larsen, Margaret Burroughs, Hiromitsu Kumada
ABSTRACTBACKGROUND: Chronic hepatitis C virus (HCV) infection with genotypes (GT) 1 and 2 accounts for over 50% of HCV infections globally, including over 97% of all HCV infections in Japan. Here, we report an integrated analysis of efficacy and safety of 8-week treatment with the all-oral, fixed-dose combination of the direct acting antivirals (DAA), glecaprevir and pibrentasvir (G/P), in DAA-naïve Japanese and overseas patients without cirrhosis and with HCV GT1 or GT2 infection. METHODS: Data from 899 DAA-naïve patients without cirrhosis and with HCV GT1 or GT2 infection treated with G/P (300/120 mg) for 8 weeks in the six Phase 2 or 3 overseas or Japan-only clinical trials were included. All patients who received ≥ 1 dose of G/P were included in an intent-to-treat (ITT) analysis. The objectives were to evaluate rate of sustained virologic response 12 weeks post-treatment (SVR12) and safety of the 8-week regimen in the ITT population. RESULTS: Overall, SVR12 was achieved by 98.9% (889/899) of DAA-naïve patients without cirrhosis, including 99.2% (597/602) of GT1-infected and 98.3% (292/297) of GT2-infected patients. Less than 1% (2/899) of patients overall and no Japanese patients experienced virologic failure. SVR12 rate was > 97% for patients regardless of baseline characteristics, and common comorbidities or co-medications. Overall, < 1% (2/899) discontinued G/P due to an adverse event (AE) and 1.6% (14/899) of patients experienced a serious AE. CONCLUSIONS: 8-week G/P treatment is safe and efficacious in DAA-naive patients without cirrhosis and with HCV GT1 or GT2 infection, demonstrating high SVR12 rates regardless of baseline patient and disease characteristics. CLINICALTRIALS. GOV IDENTIFIERS: The trials discussed in this paper were registered with ClinicalTrials.gov as follows: NCT02707952 (CERTAIN-1), NCT02723084 (CERTAIN-2), NCT02243280 (SURVEYOR-I), NCT02243293 (SURVEYOR-II), NCT02604017 (ENDURANCE-1), NCT02738138 (EXPEDITION-2). More... »
PAGES1-10
http://scigraph.springernature.com/pub.10.1007/s00535-019-01569-7
DOIhttp://dx.doi.org/10.1007/s00535-019-01569-7
DIMENSIONShttps://app.dimensions.ai/details/publication/pub.1112731619
PUBMEDhttps://www.ncbi.nlm.nih.gov/pubmed/30868245
JSON-LD is the canonical representation for SciGraph data.
TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT
[
{
"@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json",
"about": [
{
"id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1103",
"inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/",
"name": "Clinical Sciences",
"type": "DefinedTerm"
},
{
"id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11",
"inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/",
"name": "Medical and Health Sciences",
"type": "DefinedTerm"
}
],
"author": [
{
"affiliation": {
"name": [
"Department of Gastroenterology, Takasaki General Medical Center, National Hospital Organization, 36 Takamatsu-cho, 370-0829, Takasaki-shi, Gunma, Japan"
],
"type": "Organization"
},
"familyName": "Naganuma",
"givenName": "Atsushi",
"type": "Person"
},
{
"affiliation": {
"alternateName": "Hiroshima University Hospital",
"id": "https://www.grid.ac/institutes/grid.470097.d",
"name": [
"Hiroshima University Hospital, Hiroshima, Japan"
],
"type": "Organization"
},
"familyName": "Chayama",
"givenName": "Kazuaki",
"type": "Person"
},
{
"affiliation": {
"alternateName": "Fukui-ken Saiseikai Hospital",
"id": "https://www.grid.ac/institutes/grid.415130.2",
"name": [
"Fukuiken Saiseikai Hospital, Fukui, Japan"
],
"type": "Organization"
},
"familyName": "Notsumata",
"givenName": "Kazuo",
"type": "Person"
},
{
"affiliation": {
"alternateName": "Auckland City Hospital",
"id": "https://www.grid.ac/institutes/grid.414055.1",
"name": [
"Liver Unit, Auckland City Hospital, Auckland, New Zealand"
],
"type": "Organization"
},
"familyName": "Gane",
"givenName": "Edward",
"type": "Person"
},
{
"affiliation": {
"alternateName": "Queen Mary University of London",
"id": "https://www.grid.ac/institutes/grid.4868.2",
"name": [
"Queen Mary University of London, Barts Health, London, UK"
],
"type": "Organization"
},
"familyName": "Foster",
"givenName": "Graham R.",
"type": "Person"
},
{
"affiliation": {
"alternateName": "University of Colorado Denver",
"id": "https://www.grid.ac/institutes/grid.241116.1",
"name": [
"Denver Health Division of Infectious Diseases, University of Colorado, Denver, CO, USA"
],
"type": "Organization"
},
"familyName": "Wyles",
"givenName": "David",
"type": "Person"
},
{
"affiliation": {
"alternateName": "Lucile Packard Children's Hospital",
"id": "https://www.grid.ac/institutes/grid.414123.1",
"name": [
"Division of Gastroenterology and Hepatology, Stanford University, Palo Alto, CA, USA"
],
"type": "Organization"
},
"familyName": "Kwo",
"givenName": "Paul",
"type": "Person"
},
{
"affiliation": {
"alternateName": "AbbVie (United States)",
"id": "https://www.grid.ac/institutes/grid.431072.3",
"name": [
"AbbVie Inc., North Chicago, IL, USA"
],
"type": "Organization"
},
"familyName": "Crown",
"givenName": "Eric",
"type": "Person"
},
{
"affiliation": {
"alternateName": "AbbVie (United States)",
"id": "https://www.grid.ac/institutes/grid.431072.3",
"name": [
"AbbVie Inc., North Chicago, IL, USA"
],
"type": "Organization"
},
"familyName": "Bhagat",
"givenName": "Abhi",
"type": "Person"
},
{
"affiliation": {
"alternateName": "AbbVie (United States)",
"id": "https://www.grid.ac/institutes/grid.431072.3",
"name": [
"AbbVie Inc., North Chicago, IL, USA"
],
"type": "Organization"
},
"familyName": "Mensa",
"givenName": "Federico J.",
"type": "Person"
},
{
"affiliation": {
"alternateName": "AbbVie (United States)",
"id": "https://www.grid.ac/institutes/grid.431072.3",
"name": [
"AbbVie Inc., North Chicago, IL, USA"
],
"type": "Organization"
},
"familyName": "Otani",
"givenName": "Tetsuya",
"type": "Person"
},
{
"affiliation": {
"alternateName": "AbbVie (United States)",
"id": "https://www.grid.ac/institutes/grid.431072.3",
"name": [
"AbbVie Inc., North Chicago, IL, USA"
],
"type": "Organization"
},
"familyName": "Larsen",
"givenName": "Lois",
"type": "Person"
},
{
"affiliation": {
"alternateName": "AbbVie (United States)",
"id": "https://www.grid.ac/institutes/grid.431072.3",
"name": [
"AbbVie Inc., North Chicago, IL, USA"
],
"type": "Organization"
},
"familyName": "Burroughs",
"givenName": "Margaret",
"type": "Person"
},
{
"affiliation": {
"alternateName": "Toranomon Hospital",
"id": "https://www.grid.ac/institutes/grid.410813.f",
"name": [
"Toranomon Hospital, Tokyo, Japan"
],
"type": "Organization"
},
"familyName": "Kumada",
"givenName": "Hiromitsu",
"type": "Person"
}
],
"citation": [
{
"id": "https://doi.org/10.1002/hep.21669",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1019271564"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1002/hep.27259",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1020969255"
],
"type": "CreativeWork"
},
{
"id": "sg:pub.10.1007/s10620-015-3717-6",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1022721966",
"https://doi.org/10.1007/s10620-015-3717-6"
],
"type": "CreativeWork"
},
{
"id": "sg:pub.10.1007/s12072-015-9629-x",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1022897071",
"https://doi.org/10.1007/s12072-015-9629-x"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1002/hep.20984",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1023750268"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1002/hep.20984",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1023750268"
],
"type": "CreativeWork"
},
{
"id": "sg:pub.10.1038/nrneph.2015.5",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1028735473",
"https://doi.org/10.1038/nrneph.2015.5"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1097/qad.0000000000000903",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1029299810"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1097/qad.0000000000000903",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1029299810"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1002/hep.21178",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1029848202"
],
"type": "CreativeWork"
},
{
"id": "sg:pub.10.1007/s40261-015-0338-y",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1030282174",
"https://doi.org/10.1007/s40261-015-0338-y"
],
"type": "CreativeWork"
},
{
"id": "sg:pub.10.1007/s00535-016-1285-y",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1036780607",
"https://doi.org/10.1007/s00535-016-1285-y"
],
"type": "CreativeWork"
},
{
"id": "sg:pub.10.1007/s00535-016-1285-y",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1036780607",
"https://doi.org/10.1007/s00535-016-1285-y"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1111/j.1365-2036.2010.04370.x",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1037875787"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1111/j.1365-2036.2010.04370.x",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1037875787"
],
"type": "CreativeWork"
},
{
"id": "sg:pub.10.1038/nrgastro.2015.53",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1038441761",
"https://doi.org/10.1038/nrgastro.2015.53"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1111/jgh.13500",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1040593730"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1016/j.jhep.2016.09.001",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1047029346"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1016/j.jhep.2016.09.001",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1047029346"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1093/cid/civ860",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1048646621"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1111/j.1440-1746.2009.05789.x",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1050770315"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1111/j.1440-1746.2009.05789.x",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1050770315"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1111/apt.13514",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1052558497"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1111/hepr.12645",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1053735640"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1111/hepr.12645",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1053735640"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1128/aac.02558-16",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1083811304"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1016/j.jhep.2017.03.039",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1084815514"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1016/s0168-8278(17)31432-0",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1085393072"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1080/14656566.2017.1346609",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1086151721"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1002/hep.29510",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1091423354"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1016/j.cgh.2017.09.027",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1091896916"
],
"type": "CreativeWork"
},
{
"id": "sg:pub.10.1007/s00535-017-1391-5",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1091916481",
"https://doi.org/10.1007/s00535-017-1391-5"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1056/nejmoa1704053",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1092170809"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1128/aac.01620-17",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1092448553"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1128/aac.02217-17",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1093036262"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1111/liv.13685",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1100166789"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1111/liv.13685",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1100166789"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1056/nejmoa1702417",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1100623663"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1016/j.jhep.2018.03.007",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1101548772"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1093/cid/ciy220",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1101608911"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1093/cid/ciy220",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1101608911"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1016/j.jhep.2018.03.026",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1103190880"
],
"type": "CreativeWork"
},
{
"id": "https://doi.org/10.1016/s0168-8278(18)30803-1",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1103592138"
],
"type": "CreativeWork"
},
{
"id": "sg:pub.10.1186/s12879-018-3148-z",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1104168486",
"https://doi.org/10.1186/s12879-018-3148-z"
],
"type": "CreativeWork"
},
{
"id": "sg:pub.10.1186/s12879-018-3148-z",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1104168486",
"https://doi.org/10.1186/s12879-018-3148-z"
],
"type": "CreativeWork"
},
{
"id": "sg:pub.10.1007/s12072-018-9878-6",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1105731963",
"https://doi.org/10.1007/s12072-018-9878-6"
],
"type": "CreativeWork"
}
],
"datePublished": "2019-03-13",
"datePublishedReg": "2019-03-13",
"description": "BACKGROUND: Chronic hepatitis C virus (HCV) infection with genotypes (GT) 1 and 2 accounts for over 50% of HCV infections globally, including over 97% of all HCV infections in Japan. Here, we report an integrated analysis of efficacy and safety of 8-week treatment with the all-oral, fixed-dose combination of the direct acting antivirals (DAA), glecaprevir and pibrentasvir (G/P), in DAA-na\u00efve Japanese and overseas patients without cirrhosis and with HCV GT1 or GT2 infection.\nMETHODS: Data from 899 DAA-na\u00efve patients without cirrhosis and with HCV GT1 or GT2 infection treated with G/P (300/120\u00a0mg) for 8\u00a0weeks in the six Phase 2 or 3 overseas or Japan-only clinical trials were included. All patients who received \u2265\u20091 dose of G/P were included in an intent-to-treat (ITT) analysis. The objectives were to evaluate rate of sustained virologic response 12\u00a0weeks post-treatment (SVR12) and safety of the 8-week regimen in the ITT population.\nRESULTS: Overall, SVR12 was achieved by 98.9% (889/899) of DAA-na\u00efve patients without cirrhosis, including 99.2% (597/602) of GT1-infected and 98.3% (292/297) of GT2-infected patients.\u2009Less than\u00a01% (2/899) of patients overall and no Japanese patients experienced virologic failure. SVR12 rate was >\u200997% for patients regardless of baseline characteristics, and common comorbidities or co-medications. Overall, <\u20091% (2/899) discontinued G/P due to an adverse event (AE) and 1.6% (14/899) of patients experienced a serious AE.\nCONCLUSIONS: 8-week G/P treatment is safe and efficacious in DAA-naive patients without cirrhosis and with HCV GT1 or GT2 infection, demonstrating high SVR12 rates regardless of baseline patient and disease characteristics. CLINICALTRIALS.\nGOV IDENTIFIERS: The trials discussed in this paper were registered with ClinicalTrials.gov as follows: NCT02707952 (CERTAIN-1), NCT02723084 (CERTAIN-2), NCT02243280 (SURVEYOR-I), NCT02243293 (SURVEYOR-II), NCT02604017 (ENDURANCE-1), NCT02738138 (EXPEDITION-2).",
"genre": "research_article",
"id": "sg:pub.10.1007/s00535-019-01569-7",
"inLanguage": [
"en"
],
"isAccessibleForFree": false,
"isPartOf": [
{
"id": "sg:journal.1009747",
"issn": [
"0944-1174",
"1435-5922"
],
"name": "Journal of Gastroenterology",
"type": "Periodical"
}
],
"name": "Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection",
"pagination": "1-10",
"productId": [
{
"name": "readcube_id",
"type": "PropertyValue",
"value": [
"d9b3895a2715f83059a597085c9fe71a0dd8de5be1d8929953066dc25ac0818a"
]
},
{
"name": "pubmed_id",
"type": "PropertyValue",
"value": [
"30868245"
]
},
{
"name": "nlm_unique_id",
"type": "PropertyValue",
"value": [
"9430794"
]
},
{
"name": "doi",
"type": "PropertyValue",
"value": [
"10.1007/s00535-019-01569-7"
]
},
{
"name": "dimensions_id",
"type": "PropertyValue",
"value": [
"pub.1112731619"
]
}
],
"sameAs": [
"https://doi.org/10.1007/s00535-019-01569-7",
"https://app.dimensions.ai/details/publication/pub.1112731619"
],
"sdDataset": "articles",
"sdDatePublished": "2019-04-11T11:36",
"sdLicense": "https://scigraph.springernature.com/explorer/license/",
"sdPublisher": {
"name": "Springer Nature - SN SciGraph project",
"type": "Organization"
},
"sdSource": "s3://com-uberresearch-data-dimensions-target-20181106-alternative/cleanup/v134/2549eaecd7973599484d7c17b260dba0a4ecb94b/merge/v9/a6c9fde33151104705d4d7ff012ea9563521a3ce/jats-lookup/v90/0000000358_0000000358/records_127426_00000011.jsonl",
"type": "ScholarlyArticle",
"url": "https://link.springer.com/10.1007%2Fs00535-019-01569-7"
}
]Download the RDF metadata as: json-ld nt turtle xml License info
JSON-LD is a popular format for linked data which is fully compatible with JSON.
curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1007/s00535-019-01569-7'
N-Triples is a line-based linked data format ideal for batch operations.
curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1007/s00535-019-01569-7'
Turtle is a human-readable linked data format.
curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s00535-019-01569-7'
RDF/XML is a standard XML format for linked data.
curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s00535-019-01569-7'
This table displays all metadata directly associated to this object as RDF triples.
280 TRIPLES
21 PREDICATES
62 URIs
18 LITERALS
7 BLANK NODES