{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,16]],"date-time":"2026-01-16T00:46:46Z","timestamp":1768524406871,"version":"3.49.0"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2020,9,5]],"date-time":"2020-09-05T00:00:00Z","timestamp":1599264000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"National Health and Medical Research Council of Australia","award":["1142976"],"award-info":[{"award-number":["1142976"]}]},{"name":"National Health and Medical Research Council of Australia","award":["1112297"],"award-info":[{"award-number":["1112297"]}]},{"DOI":"10.13039\/501100000925","name":"NHMRC","doi-asserted-by":"publisher","award":["1053206"],"award-info":[{"award-number":["1053206"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"NHMRC","doi-asserted-by":"publisher","award":["1132902"],"award-info":[{"award-number":["1132902"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"NHMRC","doi-asserted-by":"publisher","award":["1116161"],"award-info":[{"award-number":["1116161"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,11,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>In clinical trials, hepatitis C virus (HCV) salvage treatment with sofosbuvir\/velpatasvir\/voxilaprevir (SOF\/VEL\/VOX) achieved an SVR12 rate of &amp;gt;95% in NS5A-experienced participants. Lower SVR12 rates have been reported in real-world studies, particularly for genotype (GT)3 infection and cirrhosis. We determined the efficacy and safety of SOF\/VEL\/VOX in a large real-world cohort.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We assessed the efficacy of salvage SOF\/VEL\/VOX for HCV infection in NS5A-inhibitor experienced participants with cirrhosis and portal hypertension, prior liver transplantation (LT) or severe extra-hepatic manifestations. SOF\/VEL\/VOX was available via an early access program. The primary outcome was SVR12. Secondary outcome was frequency of adverse events (AE).<\/jats:p><\/jats:sec><jats:sec><jats:title>Findings<\/jats:title><jats:p>Ninety-seven participants were included. Median age was 58, 82% were male, 78% had cirrhosis, most with portal hypertension (61%, n\u2005=\u200546\/76), and 18% had prior-LT. Of the cirrhotic participants, 96% were Child-Turcotte-Pugh class A, and 4% were class B. Of the 72% with GT3, 76% were also cirrhotic. By intention-to-treat analysis, SVR12 rate was 85% (n\u2005=\u200582\/97). Per protocol, the SVR12 rate was 90%, including 91% in GT1 (GT1a n\u2005=\u200518\/18, GT1b n\u2005=\u20052\/4), 89% in GT3 (n\u2005=\u200559\/66) and 100% in GT6 (n\u2005=\u20053\/3). SVR12 in participants with GT3 and cirrhosis was 90%. No predictors of non-SVR12 were identified. There were 4 serious AEs including 1 death and 3 hepatic decompensation events. NS5A resistance-associated substitutions detected at baseline did not affect SVR12.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This real-world study confirms high efficacy of SOF\/VEL\/VOX for the treatment of difficult-to-cure NS5A-inhibitor experienced patients, including those with GT3 and cirrhosis. Treatment was well tolerated in most; however, serious AEs can occur in those with advanced liver disease.<\/jats:p><\/jats:sec>","DOI":"10.1093\/cid\/ciaa1318","type":"journal-article","created":{"date-parts":[[2020,9,2]],"date-time":"2020-09-02T11:25:12Z","timestamp":1599045912000},"page":"e3288-e3295","source":"Crossref","is-referenced-by-count":27,"title":["Efficacy and Safety of Sofosbuvir\/Velpatasvir\/Voxilaprevir for Hepatitis C Virus (HCV) NS5A-Inhibitor Experienced Patients With Difficult to Cure Characteristics"],"prefix":"10.1093","volume":"73","author":[{"given":"Timothy","family":"Papaluca","sequence":"first","affiliation":[{"name":"St Vincent\u2019s Hospital Melbourne, Victoria, Australia"},{"name":"University of Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stuart K","family":"Roberts","sequence":"additional","affiliation":[{"name":"Alfred Hospital Melbourne, Victoria, Australia"},{"name":"Monash University, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simone I","family":"Strasser","sequence":"additional","affiliation":[{"name":"Royal Prince Alfred Hospital, New South Wales, Australia"},{"name":"University of Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katherine A","family":"Stuart","sequence":"additional","affiliation":[{"name":"Princess Alexandra Hospital, Queensland, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Geoffrey","family":"Farrell","sequence":"additional","affiliation":[{"name":"Canberra Hospital, Australian Capital Territory, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerry","family":"MacQuillan","sequence":"additional","affiliation":[{"name":"Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia"},{"name":"Medical School, University of Western Australia, Nedlands, Western Australia, 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Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4621-3485","authenticated-orcid":false,"given":"Mark","family":"Douglas","sequence":"additional","affiliation":[{"name":"Westmead Hospital, New South Wales, Australia"},{"name":"Westmead Institute for Medical Research, University of Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kate","family":"New","sequence":"additional","affiliation":[{"name":"St Vincent\u2019s Hospital Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacinta","family":"O\u2019Keefe","sequence":"additional","affiliation":[{"name":"Victorian Infectious Diseases Reference Laboratory, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margaret","family":"Hellard","sequence":"additional","affiliation":[{"name":"Alfred Hospital Melbourne, Victoria, Australia"},{"name":"Monash 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