{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,28]],"date-time":"2025-10-28T15:03:34Z","timestamp":1761663814087,"version":"3.40.5"},"reference-count":23,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2019,1,3]],"date-time":"2019-01-03T00:00:00Z","timestamp":1546473600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100009947","name":"Merck Sharp and Dohme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009947","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2019,3]]},"abstract":"Summary<\/jats:title>European treatment guidelines for hepatitis C virus (HCV<\/jats:styled-content>) infection recommend that people with genotype (GT<\/jats:styled-content>) 1a infection and baseline viral load \u2264800\u00a0000 IU<\/jats:styled-content>\/mL<\/jats:styled-content> receive elbasvir\/grazoprevir (EBR<\/jats:styled-content>\/GZR<\/jats:styled-content>) for 12\u00a0weeks, and those with baseline viral load >800\u00a0000 IU<\/jats:styled-content>\/mL<\/jats:styled-content> receive EBR<\/jats:styled-content>\/GZR<\/jats:styled-content> plus ribavirin for 16\u00a0weeks. This analysis was conducted to clarify whether baseline viral load can serve as an accurate, sensitive or specific stratification factor for defining EBR<\/jats:styled-content>\/GZR<\/jats:styled-content> regimens. In this post hoc, integrated analysis, participants with GT<\/jats:styled-content>1a infection who received EBR<\/jats:styled-content> 50\u00a0mg\/GZR<\/jats:styled-content> 100\u00a0mg for 12\u00a0weeks were stratified according to baseline viral load. Sustained virologic response at 12\u00a0weeks post\u2010treatment was achieved by 95.2% (911\/957) of participants and was higher among participants with baseline viral load \u2264800\u00a0000\u00a0IU<\/jats:styled-content>\/mL<\/jats:styled-content> vs >800\u00a0000\u00a0IU<\/jats:styled-content>\/mL<\/jats:styled-content> (98.5% vs 93.9%). The 800\u00a0000\u00a0IU<\/jats:styled-content>\/mL<\/jats:styled-content> threshold had a positive predictive value of 98.5%, a negative predictive value of 6.1%, a specificity of 91.3%, a sensitivity of 28.4% and an overall accuracy of 31.5%. A baseline viral load cutpoint of 800\u00a0000\u00a0IU<\/jats:styled-content>\/mL<\/jats:styled-content> had high positive predictive value and specificity but poor negative predictive value, sensitivity and accuracy in predicting treatment outcomes in this population. Baseline NS<\/jats:styled-content>5A resistance\u2010associated substitutions (RAS<\/jats:styled-content>s) were detected in 25% (1\/4) of virologic failures with baseline viral load \u2264800\u00a0000\u00a0IU<\/jats:styled-content>\/mL<\/jats:styled-content> and 59.5% (25\/42) of those with baseline viral load >800\u00a0000\u00a0IU<\/jats:styled-content>\/mL<\/jats:styled-content>. Overall, these data suggest that, compared with the use of a baseline viral load cutpoint, baseline testing for NS<\/jats:styled-content>5A RAS<\/jats:styled-content>s enables more individuals to receive the 12\u2010week EBR<\/jats:styled-content>\/GZR<\/jats:styled-content> regimen without compromising the opportunity for SVR.<\/jats:p>","DOI":"10.1111\/jvh.13037","type":"journal-article","created":{"date-parts":[[2018,11,9]],"date-time":"2018-11-09T16:13:49Z","timestamp":1541780029000},"page":"329-336","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["The accuracy of baseline viral load for predicting the efficacy of elbasvir\/grazoprevir in participants with hepatitis C virus genotype 1a infection: An integrated analysis"],"prefix":"10.1111","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3055-5579","authenticated-orcid":false,"given":"Lawrence","family":"Serfaty","sequence":"first","affiliation":[{"name":"Service d\u2019H\u00e9patogastroent\u00e9rologie H\u00f4pital Hautepierre Strasbourg France"},{"name":"INSERM UMR_S938 Sorbonne Universit\u00e9 Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ira","family":"Jacobson","sequence":"additional","affiliation":[{"name":"New York University School of Medicine New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J\u00fcrgen","family":"Rockstroh","sequence":"additional","affiliation":[{"name":"Bonn University Hospital Bonn Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frederick L.","family":"Altice","sequence":"additional","affiliation":[{"name":"Yale University New Haven Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peggy","family":"Hwang","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. Kenilworth New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eliav","family":"Barr","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. Kenilworth New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Robertson","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. Kenilworth New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara","family":"Haber","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. Kenilworth New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,1,3]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"2018 Merck & Co. Inc. Kenilworth NJ"},{"key":"e_1_2_8_3_1","unstructured":"European Medicines Agency.Zepatier (elbasvir\/grazoprevir): EPAR summary for the public.http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Summary_for_the_public\/human\/004126\/WC500211238.pdf. Accessed March 27 2017."},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00324-12"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1021\/ml300017p"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/cmdc.201300343"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.7326\/M15-0785"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.09.045"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)00349-9"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2017.01.050"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(15)00114-9"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-017-0492-5"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.10.017"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2016.09.001"},{"key":"e_1_2_8_15_1","first-page":"151","volume-title":"Zepatier EMA CHMP Assessment Report","author":"European Medicines Agency","year":"2016"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)61793-1"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)61795-5"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.7326\/M16-0816"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2016.07.050"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-016-1285-y"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.29139"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep4.1177"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0168-8278(17)31460-5"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0168-8278(15)30015-5"}],"container-title":["Journal of Viral Hepatitis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fjvh.13037","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jvh.13037","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,14]],"date-time":"2023-09-14T04:15:30Z","timestamp":1694664930000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jvh.13037"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,1,3]]},"references-count":23,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2019,3]]}},"alternative-id":["10.1111\/jvh.13037"],"URL":"https:\/\/doi.org\/10.1111\/jvh.13037","archive":["Portico"],"relation":{},"ISSN":["1352-0504","1365-2893"],"issn-type":[{"type":"print","value":"1352-0504"},{"type":"electronic","value":"1365-2893"}],"subject":[],"published":{"date-parts":[[2019,1,3]]},"assertion":[{"value":"2018-07-19","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-10-19","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-01-03","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}