{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T14:18:36Z","timestamp":1761920316786,"version":"3.37.3"},"reference-count":27,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2017,6,29]],"date-time":"2017-06-29T00:00:00Z","timestamp":1498694400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2017,8]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Patients with thalassaemia major depend on blood transfusions. In Italy, up to 80% of thalassaemia patients bear <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> antibodies due to <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> contaminated transfusions before 1990. Thalassaemia patients with <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> infection have high risk of developing <jats:styled-content style=\"fixed-case\">HCC<\/jats:styled-content>. Treatment based on Pegylated\u2010<jats:styled-content style=\"fixed-case\">IFN<\/jats:styled-content> (Peg\u2010<jats:styled-content style=\"fixed-case\">IFN<\/jats:styled-content>) and Ribavirin (<jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content>) was limited by relevant side effects.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To evaluate the impact of Sofosbuvir\/Ledipasvir (<jats:styled-content style=\"fixed-case\">SOF<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">LDV<\/jats:styled-content>) fixed dose combination for 12\u00a0weeks without <jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content>, in patients with thalassaemia major and <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> Genotype 1 or 4 (<jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>1\/4).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Open label, historically\u2010controlled, nationwide multicentre study in thalassaemia patients including na\u00efve with cirrhosis and prior treatment failure without cirrhosis. <jats:styled-content style=\"fixed-case\">SOF<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">LDV<\/jats:styled-content> single pill was administered for 12\u00a0weeks to 100 patients of whom 16% had cirrhosis. The control group included 96 patients with comparable baseline characteristics treated with Peg\u2010<jats:styled-content style=\"fixed-case\">IFN<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content>. The primary end point was sustained virologic response at follow\u2010up week 12 or 24 after <jats:styled-content style=\"fixed-case\">IFN<\/jats:styled-content>\u2010free or Peg\u2010<jats:styled-content style=\"fixed-case\">IFN<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content>, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the study group, sustained virological response (SVR) was reported in 98% of patients (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 95.3%\u2010100%). Cirrhotic as well as prior treatment failure achieved 100% <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>. In the control group, <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content> was 47.9% (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 37.9%\u201057.9%). Adverse events including fatigue, headache, nausea, decrease in haemoglobin or increase in ferritin levels were rare and significantly less common in the study than in the historical control group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In conclusion, <jats:styled-content style=\"fixed-case\">SOF<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">LDV<\/jats:styled-content> for 12\u00a0weeks provides simple, highly effective and safe Peg\u2010IFN\/RBV\u2010free treatment for <jats:styled-content style=\"fixed-case\">HCV GT<\/jats:styled-content>1\/4 thalassaemia patients. <jats:styled-content style=\"fixed-case\">EUDRACT<\/jats:styled-content> number 2015\u2010002401\u20101.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.14197","type":"journal-article","created":{"date-parts":[[2017,6,29]],"date-time":"2017-06-29T06:22:41Z","timestamp":1498717361000},"page":"424-431","source":"Crossref","is-referenced-by-count":38,"title":["Randomised clinical trial: sofosbuvir and ledipasvir in patients with transfusion\u2010dependent thalassaemia and <scp>HCV<\/scp> genotype 1 or 4 infection"],"prefix":"10.1111","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9633-8019","authenticated-orcid":false,"given":"A.","family":"Mangia","sequence":"first","affiliation":[{"name":"Liver Unit IRCCS San Giovanni Rotondo Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R.","family":"Sarli","sequence":"additional","affiliation":[{"name":"Transfusional Medicine Hospital G. 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