{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T22:18:59Z","timestamp":1782253139932,"version":"3.54.5"},"reference-count":52,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2017,9,5]],"date-time":"2017-09-05T00:00:00Z","timestamp":1504569600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"National Health Insurance Agency"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2018,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Direct antiviral agents (<jats:styled-content style=\"fixed-case\">DAA<\/jats:styled-content>) showed very good results in terms of efficacy and safety in clinical trials, but real\u2010life data are still needed in order to confirm this profile.<\/jats:p><\/jats:sec><jats:sec><jats:title>Material and methods<\/jats:title><jats:p>In Romania, through a nationwide government\u2010funded programme in 2015\u20102016, approx.5800 patients with virus C cirrhosis received fully reimbursed <jats:styled-content style=\"fixed-case\">DAA<\/jats:styled-content> therapy with <jats:styled-content style=\"fixed-case\">OBV<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">PTV<\/jats:styled-content>\/r+<jats:styled-content style=\"fixed-case\">DSV<\/jats:styled-content>+<jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content> for 12\u00a0weeks. We analysed a national prospective cohort enrolling the first 2070 patients, all with genotype 1b. The only key inclusion criteria was advanced fibrosis (Metavir stage F4) confirmed by Fibromax testing (or liver biopsy\/Fibroscan). Efficacy was assessed by the percentage of patients achieving <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content> 12\u00a0weeks post\u2010treatment (<jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Forty patients stopped the treatment because of hepatic decompensation (1.9%), 21 stopped because of other adverse events and one was lost to follow\u2010up. This cohort was 51% females, mean age 60\u00a0years (25\u00f782), 67% pretreated, 70% associated <jats:styled-content style=\"fixed-case\">NASH<\/jats:styled-content>, 67% with severe necro\u2010inflammation (severity score 3\u2010Fibromax), 37% with comorbidities, 10.4% with Child Pugh A6, 0.5% B7. The median <jats:styled-content style=\"fixed-case\">MELD<\/jats:styled-content> score was 8.09 (6 \u00f7 22). <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content> by intention\u2010to\u2010treat was reported in 1999\/2070(96.6%), 55\/2070 failed to respond. Liver decompensation was statistically associated in multivariate analysis with platelets&lt; 10<jats:sup>5<\/jats:sup>\/mm<jats:sup>3<\/jats:sup>(<jats:italic>P<\/jats:italic>\u00a0=\u00a0.03), increased total bilirubin (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a0.001), prolonged <jats:styled-content style=\"fixed-case\">INR<\/jats:styled-content> (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.02), and albumin&lt;3.5\u00a0g\/dL (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.03).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">OBV<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">PTV<\/jats:styled-content>\/r+<jats:styled-content style=\"fixed-case\">DSV<\/jats:styled-content>+<jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content> proved to be highly efficient in our population of cirrhotics with a 96.6% <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>. Serious adverse events related to therapy were reported in 61\/2070(2.9%), most of them liver decompensation (1.9%), related to hepatic dysfunction, and lower platelet count.<\/jats:p><\/jats:sec>","DOI":"10.1111\/liv.13550","type":"journal-article","created":{"date-parts":[[2017,8,17]],"date-time":"2017-08-17T08:40:47Z","timestamp":1502959247000},"page":"602-610","source":"Crossref","is-referenced-by-count":16,"title":["Real\u2010world efficacy and safety of ombitasvir, paritaprevir\/r+dasabuvir+ribavirin in genotype 1b patients with hepatitis C virus cirrhosis"],"prefix":"10.1111","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2675-7971","authenticated-orcid":false,"given":"Carmen M.","family":"Preda","sequence":"first","affiliation":[{"name":"UMF \u201cCarol Davila\u201d Gastroenterology &amp; Hepatology Department Clinic Fundeni Institute  Bucharest Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corneliu P.","family":"Popescu","sequence":"additional","affiliation":[{"name":"UMF \u201cCarol Davila\u201d Virology Department Victor Babes Hospital  Bucharest Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristian","family":"Baicus","sequence":"additional","affiliation":[{"name":"UMF \u201cCarol Davila\u201d Internal Medicine Department Colentina Hospital  Bucharest Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theodor A.","family":"Voiosu","sequence":"additional","affiliation":[{"name":"UMF \u201cCarol Davila\u201d Internal Medicine Department Colentina Hospital  Bucharest Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mircea","family":"Manuc","sequence":"additional","affiliation":[{"name":"UMF \u201cCarol Davila\u201d Gastroenterology &amp; 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