{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T20:46:46Z","timestamp":1791406006339,"version":"4.3.3"},"reference-count":34,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","license":[{"start":{"date-parts":[[2015,9,1]],"date-time":"2015-09-01T00:00:00Z","timestamp":1441065600000},"content-version":"tdm","delay-in-days":22,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"crossref","award":["None"],"award-info":[{"award-number":["None"]}],"id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2015,10]]},"abstract":"<jats:p>Alisporivir is a cyclophilin inhibitor with pan\u2010genotypic anti\u2013hepatitis C virus (HCV) activity and a high barrier to viral resistance. The VITAL\u20101 study assessed alisporivir as interferon (IFN)\u2010free therapy in treatment\u2010na\u00efve patients infected with HCV genotype 2 or 3. Three hundred forty patients without cirrhosis were randomized to: arm 1, alisporivir (ALV) 1,000 mg once\u2010daily (QD); arm 2, ALV 600 mg QD and ribavirin (RBV); arm 3, ALV 800 mg QD and RBV; arm 4, ALV 600 mg QD and pegylated IFN (Peg\u2010IFN); or arm 5, Peg\u2010IFN and RBV. Patients receiving IFN\u2010free ALV regimens who achieved rapid virological response (RVR) continued the same treatment throughout, whereas those with detectable HCV RNA at week 4 received ALV, RBV, and Peg\u2010IFN from weeks 6 to 24. Overall, 300 patients received ALV\u2010based regimens. In arm 1 to arm 4, the intent\u2010to\u2010treat rates of sustained virological response (SVR) 24 weeks after treatment (SVR24) were from 80% to 85%, compared with 58% (n\u2009=\u200923 of 40) with Peg\u2010IFN\/RBV. Per\u2010protocol analysis showed higher SVR24 rates in patients who received ALV\/RBV, IFN\u2010free after RVR (92%; n\u2009=\u200956 of 61) than with ALV alone after RVR (72%; n\u2009=\u200913 of 18) or with Peg\u2010IFN\/RBV (70%; n\u2009=\u200923 of 33). Both RVRs and SVRs to ALV IFN\u2010free regimens were numerically higher in genotype 3\u2013 than in genotype 2\u2013infected patients. Viral breakthrough was infrequent (3%; n\u2009=\u20097 of 258). IFN\u2010free ALV treatment showed markedly better safety\/tolerability than IFN\u2010containing regimens.<jats:italic toggle=\"yes\">Conclusions<\/jats:italic>: ALV plus RBV represents an effective IFN\u2010free option for a proportion of patients with HCV genotype 2 or 3 infections, with high SVR rates for patients with early viral clearance. Further investigations of ALV in IFN\u2010free combination regimens with direct\u2010acting antiviral drugs deserve exploration in future trials. (H<jats:sc>epatology<\/jats:sc>2015;62:1013\u20101023)<\/jats:p>","DOI":"10.1002\/hep.27960","type":"journal-article","created":{"date-parts":[[2015,6,27]],"date-time":"2015-06-27T17:04:24Z","timestamp":1435424664000},"page":"1013-1023","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":53,"title":["Alisporivir plus ribavirin, interferon free or in combination with pegylated interferon, for hepatitis C virus genotype 2 or 3 infection"],"prefix":"10.1097","volume":"62","author":[{"given":"Jean\u2010Michel","family":"Pawlotsky","sequence":"first","affiliation":[{"name":"National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology,H\u00f4pital Henri Mondor, Universit\u00e9 Paris\u2010Est,Cr\u00e9teil,France"},{"name":"INSERM U955,Cr\u00e9teil,France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Flisiak","sequence":"additional","affiliation":[{"name":"Medical University of Bialystok,Bialystok,Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shiv K.","family":"Sarin","sequence":"additional","affiliation":[{"name":"Institute of Liver and Biliary Sciences,New Delhi,India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jens","family":"Rasenack","sequence":"additional","affiliation":[{"name":"Klinikum der Albert\u2010Ludwigs\u2010Universit\u00e4t,Freiburg,Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teerha","family":"Piratvisuth","sequence":"additional","affiliation":[{"name":"Prince of Songkla University, Songklanagarind Hospital,Hat\u2010Yai,Songkhla,Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wan\u2010Long","family":"Chuang","sequence":"additional","affiliation":[{"name":"Kaohsiung Medical University, Chang\u2010Ho Memorial Hospital,Kaohsiung,Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheng\u2010Yuan","family":"Peng","sequence":"additional","affiliation":[{"name":"School of Medicine,China Medical University,Taichung,Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graham R.","family":"Foster","sequence":"additional","affiliation":[{"name":"Bart's and The London School of Medicine,Queen Mary's University of London,London,United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samir","family":"Shah","sequence":"additional","affiliation":[{"name":"Global Hospitals,Mumbai,India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heiner","family":"Wedemeyer","sequence":"additional","affiliation":[{"name":"Hannover Medical School,Hannover,Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christophe","family":"H\u00e9zode","sequence":"additional","affiliation":[{"name":"INSERM U955,Cr\u00e9teil,France"},{"name":"Department of Hepatology and Gastroenterology,H\u00f4pital Henri Mondor, Universit\u00e9 Paris\u2010Est,Cr\u00e9teil,France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Beijing Novartis Pharma Co Ltd,Shanghai,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelly A.","family":"Wong","sequence":"additional","affiliation":[{"name":"Novartis Institute of Biomedical Research,Emeryville,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bin","family":"Li","sequence":"additional","affiliation":[{"name":"Novartis Institute of Biomedical Research,Cambridge,MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudio","family":"Avila","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG,Basel,Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikolai V.","family":"Naoumov","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG,Basel,Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the VITAL\u20101 study team","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2015,8,10]]},"reference":[{"key":"hep27960-bib-0001-20241017","doi-asserted-by":"crossref","first-page":"1333","DOI":"10.1002\/hep.26141","article-title":"Global epidemiology of hepatitis C virus infection: new estimates of age\u2010specific antibody to HCV seroprevalence","volume":"57","year":"2013","journal-title":"Hepatology"},{"issue":"Suppl 2","key":"hep27960-bib-0002-20241017","first-page":"30","article-title":"A systematic review of hepatitis C virus epidemiology in Europe, Canada and Israel","volume":"31","year":"2011","journal-title":"Liver Int"},{"issue":"Suppl 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