{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T11:58:58Z","timestamp":1790251138428,"version":"4.1.0"},"reference-count":37,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2021,9,8]],"date-time":"2021-09-08T00:00:00Z","timestamp":1631059200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","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":[[2021,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Sustained virologic response at posttreatment Week 12 (SVR12) is the widely accepted efficacy endpoint for direct\u2010acting antiviral agents. Those with hepatitis C virus (HCV) are presenting younger with milder liver disease, potentially reducing need for long\u2010term liver posttreatment monitoring. This analysis aimed to determine the positive predictive value (PPV) of SVR at posttreatment Week 4 (SVR4) for achieving SVR12 in patients with HCV, without cirrhosis or with compensated cirrhosis, receiving glecaprevir\/pibrentasvir (G\/P) in clinical trials. An integrated dataset from 20 Phase 2 and 3\u00a0clinical trials of G\/P was evaluated in patients with 8\u2010, 12\u2010 or 16\u2010week treatment duration consistent with the current label (label\u2010consistent group), and in all patients regardless of treatment duration consistency with the current label (overall group). Sensitivity analyses handled missing data either by backward imputation or were excluded. SVR4 PPV, negative predictive value (NPV), sensitivity and specificity were calculated for achieving SVR12 in both groups, and by treatment duration in the label\u2010consistent group. SVR was defined as HCV ribonucleic acid &lt;lower limit of quantification. The label\u2010consistent group and overall group included 2890 and 4390 patients, respectively. PPV of SVR4 for SVR12 was &gt;99% in both groups regardless of treatment duration. Not achieving SVR4\u00a0had 100% NPV and sensitivity for all groups. SVR4\u00a0measure had 79.5% specificity for identifying patients who did not achieve SVR12. Across 20 Phase 2\/3\u00a0clinical trials of G\/P, SVR4 was highly predictive of SVR12. Long\u2010term follow\u2010up to confirm SVR may not be necessary for certain populations of patients with HCV.<\/jats:p>","DOI":"10.1111\/jvh.13600","type":"journal-article","created":{"date-parts":[[2021,8,27]],"date-time":"2021-08-27T03:14:35Z","timestamp":1630034075000},"page":"1635-1642","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":31,"title":["Positive predictive value of sustained virologic response 4\u00a0weeks posttreatment for achieving sustained virologic response 12\u00a0weeks posttreatment in patients receiving glecaprevir\/pibrentasvir in Phase 2 and 3 clinical trials"],"prefix":"10.1111","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4086-7955","authenticated-orcid":false,"given":"Edward","family":"Gane","sequence":"first","affiliation":[{"name":"Faculty of Medicine University of Auckland Auckland New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6414-1951","authenticated-orcid":false,"given":"Victor","family":"de Ledinghen","sequence":"additional","affiliation":[{"name":"Centre d\u2019Investigation de la Fibrose H\u00e9patique Bordeaux University Hospital Pessac France"},{"name":"INSERM U1053 Bordeaux University Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas E.","family":"Dylla","sequence":"additional","affiliation":[{"name":"AbbVie Inc North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuliano","family":"Rizzardini","sequence":"additional","affiliation":[{"name":"1st Division of Infectious Diseases ASST Fatebenefratelli\u2010Sacco Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitchell L.","family":"Shiffman","sequence":"additional","affiliation":[{"name":"Liver Institute of Virginia Bon Secours Mercy Health Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen T.","family":"Barclay","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Glasgow Royal Infirmary Glasgow UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2265-6591","authenticated-orcid":false,"given":"Jose Luis","family":"Calleja","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Hospital Universitario Puerta de Hierro Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhenyi","family":"Xue","sequence":"additional","affiliation":[{"name":"AbbVie Inc North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaret","family":"Burroughs","sequence":"additional","affiliation":[{"name":"AbbVie Inc North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julio A.","family":"Gutierrez","sequence":"additional","affiliation":[{"name":"Scripps Center for Organ and Cell Transplantation La Jolla California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,9,8]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"World Health Organization (WHO).Global Hepatitis Report 2017. Accessed 24th February 2021.http:\/\/apps.who.int\/iris\/bitstream\/10665\/255016\/1\/9789241565455\u2010eng.pdf"},{"key":"e_1_2_12_3_1","unstructured":"World Health Organization (WHO).Global Health Sector Strategy on Viral Hepatitis. 2016\u20132021.2016. Accessed 24th February 2021.https:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/246177\/WHO\u2010HIV\u20102016.06\u2010eng.pdf;jsessionid=B789DC827B02AF7A18F792AB221CF0D5?sequence=1"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/joim.12972"},{"key":"e_1_2_12_5_1","unstructured":"World Health Organization (WHO).Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infection.2018. Accessed 24th February 2021.https:\/\/www.who.int\/hepatitis\/publications\/hepatitis\u2010c\u2010guidelines\u20102018\/en\/"},{"key":"e_1_2_12_6_1","unstructured":"AbbVie Inc.Maviret prescribing information. 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