{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T02:39:55Z","timestamp":1772159995116,"version":"3.50.1"},"reference-count":24,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2018,3,23]],"date-time":"2018-03-23T00:00:00Z","timestamp":1521763200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2018,5]]},"abstract":"Summary<\/jats:title>\n \n Background<\/jats:title>\n \n Combination therapy of simeprevir (\n SIM<\/jats:styled-content>\n )\/sofosbuvir (\n SOF<\/jats:styled-content>\n ) is an approved treatment for hepatitis C genotype (gen) 1 with overall\n SVR<\/jats:styled-content>\n 12 rate of 85%\u201095%. The single tablet fixed\u2010dose combination of ledipasvir (\n LDV<\/jats:styled-content>\n )\/\n SOF<\/jats:styled-content>\n is also approved for gen 1 with\n sustained virologic response at 12 weeks (SVR<\/jats:styled-content>\n 12) rates \u226595%. No data are available on the efficacy\u00a0of\u00a0retreatment with\n LDV<\/jats:styled-content>\n \/\n SOF<\/jats:styled-content>\n in patients who failed initial treatment with\n SIM<\/jats:styled-content>\n \/\n SOF<\/jats:styled-content>\n .\n <\/jats:p>\n <\/jats:sec>\n \n Aim<\/jats:title>\n \n To evaluate the efficacy of retreatment with\n LDV<\/jats:styled-content>\n \/\n SOF<\/jats:styled-content>\n \u00a0\u00b1\u00a0ribavirin (\n RBV<\/jats:styled-content>\n ) in gen 1 patients who had previously failed treatment with\n SIM<\/jats:styled-content>\n \/\n SOF<\/jats:styled-content>\n .\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Data from a combined treatment cohort of 2 hepatology centres, which included patients previously treated with\n SIM<\/jats:styled-content>\n \/\n SOF<\/jats:styled-content>\n \u00a0\u00b1\u00a0\n RBV<\/jats:styled-content>\n for 12\u00a0weeks but failed to achieve\n SVR<\/jats:styled-content>\n and then underwent retreatment with\n LDV<\/jats:styled-content>\n \/\n SOF<\/jats:styled-content>\n \u00a0\u00b1\u00a0\n RBV<\/jats:styled-content>\n , were analysed (n\u00a0=\u00a030).\n LDV<\/jats:styled-content>\n \/\n SOF<\/jats:styled-content>\n \u00a0\u00b1\u00a0\n RBV<\/jats:styled-content>\n was administered for 12\u201024\u00a0weeks based on the discretion of the treating hepatologist.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of the 30 patients, 23 (77%) were male, 77% were Caucasian and 26 (87%) were gen 1a. 26 (86%) had cirrhosis, of which 16 (62%) had decompensated, Child's class B or C cirrhosis. Three patients were liver transplant recipients with recurrent hepatitis C. Overall, 27\/30 (90%) achieved\n SVR<\/jats:styled-content>\n . Treatment was well tolerated with 37% reporting no adverse events. The most common adverse events were fatigue, headache, insomnia and nausea. Two patients with Child's B cirrhosis required hospitalization during treatment for variceal haemorrhage and abdominal pain respectively. However, no treatment discontinuations or deaths occurred.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n Single tablet fixed\u2010dose combination\n LDV<\/jats:styled-content>\n \/\n SOF<\/jats:styled-content>\n \u00a0\u00b1\u00a0\n RBV<\/jats:styled-content>\n is efficacious and well tolerated in patients who previously failed treatment with\n SIM<\/jats:styled-content>\n \/\n SOF<\/jats:styled-content>\n , including those with decompensated cirrhosis and recurrent hepatitis C following liver transplantation.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/apt.14604","type":"journal-article","created":{"date-parts":[[2018,3,23]],"date-time":"2018-03-23T05:49:58Z","timestamp":1521784198000},"page":"1409-1415","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Safety and efficacy of ledipasvir\/sofosbuvir with or without ribavirin in hepatitis C genotype 1 patients including those with decompensated cirrhosis who failed prior treatment with simeprevir\/sofosbuvir"],"prefix":"10.1111","volume":"47","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7336-8787","authenticated-orcid":false,"given":"A. A.","family":"Modi","sequence":"first","affiliation":[{"name":"Liver Consultants of Texas Baylor All Saints Medical Center Fort Worth TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H. E.","family":"Nazario","sequence":"additional","affiliation":[{"name":"The Liver Institute at Methodist Dallas Medical Center Dallas TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G. R.","family":"Gonzales","sequence":"additional","affiliation":[{"name":"University of North Texas Health Science Center Fort Worth TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. A.","family":"Gonzalez","sequence":"additional","affiliation":[{"name":"Liver Consultants of Texas Baylor All Saints Medical Center Fort Worth TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,3,23]]},"reference":[{"key":"e_1_2_7_2_1","volume-title":"Third National Health and Nutrition Examination Survey, 1988\u20101994, NHANES III Hepatitis C Virus Genotype data file (Series 11, No. 10A)","author":"U.S. Department of Health and Human Services (DHHS). National Center for Health Statistics","year":"2001"},{"key":"e_1_2_7_3_1","unstructured":"Simeprevir (package insert) 2013 Janssen Therapeutics Titusville NJ"},{"key":"e_1_2_7_4_1","unstructured":"Sofosbuvir (package insert) 2013 Gilead Sciences Foster City CA"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1214853"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)60494-3"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)60538-9"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2014.02.051"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2013.10.058"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)61036-9"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.28467"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.28422"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13300"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13761"},{"key":"e_1_2_7_15_1","unstructured":"Ledipasvir (package insert) 2014 Gilead Sciences Foster City CA"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.27724"},{"key":"e_1_2_7_17_1","first-page":"8","volume-title":"Hepatitis C Viruses: Genomes and Molecular Biology","author":"He Y","year":"2006"},{"key":"e_1_2_7_18_1","unstructured":"American Association for the Study of Liver Diseases and Infectious Diseases Society of America.HCV Guidance: Recommendations for testing managing and treating hepatitis C.www.hcvguidelines.orgAccessed January 2 2018."},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2015.05.010"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(16)00052-9"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1512614"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.08.004"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1613512"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.29081"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/jvh.12645"}],"container-title":["Alimentary Pharmacology & Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fapt.14604","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/apt.14604","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,17]],"date-time":"2023-09-17T05:24:59Z","timestamp":1694928299000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/apt.14604"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,3,23]]},"references-count":24,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2018,5]]}},"alternative-id":["10.1111\/apt.14604"],"URL":"https:\/\/doi.org\/10.1111\/apt.14604","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.3410\/f.732892410.793544218","asserted-by":"object"}]},"ISSN":["0269-2813","1365-2036"],"issn-type":[{"value":"0269-2813","type":"print"},{"value":"1365-2036","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,3,23]]},"assertion":[{"value":"2017-03-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-02-16","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-03-23","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}