{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,14]],"date-time":"2026-01-14T20:09:14Z","timestamp":1768421354884,"version":"3.49.0"},"reference-count":32,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2018,3,14]],"date-time":"2018-03-14T00:00:00Z","timestamp":1520985600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100001659","name":"Deutsche Forschungsgemeinschaft","doi-asserted-by":"publisher","award":["FE1746\/1\u20101"],"award-info":[{"award-number":["FE1746\/1\u20101"]}],"id":[{"id":"10.13039\/501100001659","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001659","name":"Deutsche Forschungsgemeinschaft","doi-asserted-by":"publisher","award":["SFB841 A6"],"award-info":[{"award-number":["SFB841 A6"]}],"id":[{"id":"10.13039\/501100001659","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009139","name":"Deutsches Zentrum f\u00fcr Infektionsforschung","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009139","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2018,5]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Twelve weeks of the pangenotypic direct\u2010acting antiviral (<jats:styled-content style=\"fixed-case\">DAA<\/jats:styled-content>) combination sofosbuvir\/velpatasvir (<jats:styled-content style=\"fixed-case\">SOF<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">VEL<\/jats:styled-content>) was highly efficient in patients with hepatitis C virus (<jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content>) genotype 3 (<jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>3) infection in the <jats:styled-content style=\"fixed-case\">ASTRAL<\/jats:styled-content>\u20103 approval study. However, presence of resistance\u2010associated substitutions (<jats:styled-content style=\"fixed-case\">RAS<\/jats:styled-content>s) in the <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> nonstructural protein 5A (<jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>5A) was associated with lower treatment response.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To assess the efficacy and safety of <jats:styled-content style=\"fixed-case\">SOF<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">VEL<\/jats:styled-content>\u00a0\u00b1\u00a0ribavirin (<jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content>) and the impact of <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>5A <jats:styled-content style=\"fixed-case\">RAS<\/jats:styled-content>s and <jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content> use on treatment outcome in <jats:styled-content style=\"fixed-case\">HCV GT<\/jats:styled-content>3 infection in a real\u2010world setting.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this multicentre cohort study, <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>3 patients from ten treatment centres across Germany were included. Sustained virological response was assessed 12\u00a0weeks after end\u2010of\u2010treatment (<jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12) in modified intention\u2010to\u2010treat (<jats:styled-content style=\"fixed-case\">mITT<\/jats:styled-content>) and per\u2010protocol analysis (<jats:styled-content style=\"fixed-case\">PP<\/jats:styled-content>). <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>5A <jats:styled-content style=\"fixed-case\">RAS<\/jats:styled-content>s were tested by population\u2010based sequencing.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 293 <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>3 patients were included. The median age was 48\u00a0years, 70% were male, 25.3% were cirrhotic, 9.2% were <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content> co\u2010infected and 21.8% were treatment\u2010experienced, including 4.1% with <jats:styled-content style=\"fixed-case\">DAA<\/jats:styled-content> experience. Baseline <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>5A <jats:styled-content style=\"fixed-case\">RAS<\/jats:styled-content>s (Y93H, A30K, L31M) were detected in 11.2%. <jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content> was added in 5% of noncirrhotic and 58.9% of cirrhotic patients, respectively. <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 rates for <jats:styled-content style=\"fixed-case\">SOF<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">VEL<\/jats:styled-content>\u00b1<jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content> were 95.9% (<jats:styled-content style=\"fixed-case\">mITT<\/jats:styled-content>) and 99.5% (<jats:styled-content style=\"fixed-case\">PP<\/jats:styled-content>), respectively. Only 1 virological relapse occurred in a cirrhotic patient previously treated with <jats:styled-content style=\"fixed-case\">SOF<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content>. No treatment\u2010related major adverse events occurred.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Twelve weeks of <jats:styled-content style=\"fixed-case\">SOL<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">VEL<\/jats:styled-content>\u00b1<jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content> was safe and highly efficient in <jats:styled-content style=\"fixed-case\">HCV GT<\/jats:styled-content>3 across a diverse patient population. Baseline <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>5A <jats:styled-content style=\"fixed-case\">RAS<\/jats:styled-content>s were rarely observed and presence did not seem to impact <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>, regardless of the use of <jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content>.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.14592","type":"journal-article","created":{"date-parts":[[2018,3,15]],"date-time":"2018-03-15T11:43:04Z","timestamp":1521114184000},"page":"1288-1295","source":"Crossref","is-referenced-by-count":47,"title":["High efficacy of sofosbuvir\/velpatasvir and impact of baseline resistance\u2010associated substitutions in hepatitis C genotype 3 infection"],"prefix":"10.1111","volume":"47","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2839-5174","authenticated-orcid":false,"given":"J.","family":"von Felden","sequence":"first","affiliation":[{"name":"Hamburg Germany"},{"name":"New York City NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3287-0815","authenticated-orcid":false,"given":"J.","family":"Vermehren","sequence":"additional","affiliation":[{"name":"Frankfurt Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P.","family":"Ingiliz","sequence":"additional","affiliation":[{"name":"Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Mauss","sequence":"additional","affiliation":[{"name":"Duesseldorf Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T.","family":"Lutz","sequence":"additional","affiliation":[{"name":"Frankfurt Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K. G.","family":"Simon","sequence":"additional","affiliation":[{"name":"Leverkusen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H. W.","family":"Busch","sequence":"additional","affiliation":[{"name":"Muenster Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Baumgarten","sequence":"additional","affiliation":[{"name":"Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K.","family":"Schewe","sequence":"additional","affiliation":[{"name":"Hamburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D.","family":"Hueppe","sequence":"additional","affiliation":[{"name":"Herne Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Boesecke","sequence":"additional","affiliation":[{"name":"Bonn Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. K.","family":"Rockstroh","sequence":"additional","affiliation":[{"name":"Bonn Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Daeumer","sequence":"additional","affiliation":[{"name":"Kaiserslautern Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"N.","family":"Luebke","sequence":"additional","affiliation":[{"name":"Duesseldorf Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Timm","sequence":"additional","affiliation":[{"name":"Duesseldorf Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Schulze zur Wiesch","sequence":"additional","affiliation":[{"name":"Hamburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Sarrazin","sequence":"additional","affiliation":[{"name":"Frankfurt Germany"},{"name":"Wiesbaden Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Christensen","sequence":"additional","affiliation":[{"name":"Muenster Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,3,14]]},"reference":[{"key":"e_1_2_7_2_1","volume-title":"Global Hepatitis Report 2017","year":"2017"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(16)30181-9"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.26905"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2012.144878"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2893.2011.01481.x"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2006.03.014"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2008.03763.x"},{"key":"e_1_2_7_9_1","first-page":"1405","article-title":"\u201cReal\u2010Life\u201d comparison of pegylated\u2010interferon 2a versus 2b combination therapy of chronic hepatitis C virus","volume":"53","author":"Schulze Zur Wiesch J","year":"2011","journal-title":"Hepatology"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2016.10.034"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2015.09.011"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1512612"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1512610"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2017.11.032"},{"key":"e_1_2_7_15_1","unstructured":"European Medicines Agency: Epclusa \u2010 EMEA\/H\/C\/004210 \u2010 II\/0012 \u2010 EPAR \u2010 Product Information 2016.http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/004210\/WC500211151.pdf. Nov 2017"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofx158"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciw567"},{"key":"e_1_2_7_18_1","doi-asserted-by":"crossref","first-page":"81","DOI":"10.3851\/IMP3094","article-title":"Effect of antiviral therapy for HCV on lipid levels","volume":"21","author":"Mauss S","year":"2017","journal-title":"Antivir Ther"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.24903"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0134395"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00763-16"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciw387"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13925"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1613512"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2016.09.001"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.29256"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1512614"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2012.12.020"},{"key":"e_1_2_7_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.27726"},{"key":"e_1_2_7_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.27950"},{"key":"e_1_2_7_31_1","article-title":"Patterns of resistance\u2010associated substitutions in patients with chronic hcv infection following treatment with direct\u2010acting antivirals","author":"Dietz J","year":"2017","journal-title":"Gastroenterology"},{"key":"e_1_2_7_32_1","doi-asserted-by":"publisher","DOI":"10.1080\/17425255.2017.1351942"},{"key":"e_1_2_7_33_1","first-page":"419a","article-title":"Pharmacokinetics of sofosbuvir\/velpatasvir and tenofovir in subjects with HCV\/HIV coinfection using boosted or unboosted antiretroviral regimens","volume":"64","author":"Mogalian E","year":"2016","journal-title":"Hepatology"}],"container-title":["Alimentary Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fapt.14592","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/apt.14592","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,18]],"date-time":"2023-09-18T03:42:47Z","timestamp":1695008567000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/apt.14592"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,3,14]]},"references-count":32,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2018,5]]}},"alternative-id":["10.1111\/apt.14592"],"URL":"https:\/\/doi.org\/10.1111\/apt.14592","archive":["Portico"],"relation":{},"ISSN":["0269-2813","1365-2036"],"issn-type":[{"value":"0269-2813","type":"print"},{"value":"1365-2036","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,3,14]]}}}