{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T15:10:47Z","timestamp":1772118647253,"version":"3.50.1"},"reference-count":12,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"2","license":[{"start":{"date-parts":[[2015,12,18]],"date-time":"2015-12-18T00:00:00Z","timestamp":1450396800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2016,2]]},"abstract":"<jats:p>\n                    Black patients chronically infected with genotype 1 hepatitis C virus (HCV) have historically had lower rates of response to interferon\u2010based treatment than patients of other races. In the phase 3 ION program, the single\u2010tablet regimen of the NS5A inhibitor ledipasvir and NS5B nucleotide polymerase inhibitor sofosbuvir was shown to be safe and highly effective in the general population. The aim of this study was to evaluate the safety and efficacy of ledipasvir\/sofosbuvir in black patients using data from the three open\u2010label ION clinical trials, which evaluated the safety and efficacy of 8, 12, and 24 weeks of ledipasvir\/sofosbuvir with or without ribavirin for the treatment of treatment\u2010na\u00efve and treatment\u2010experienced patients with genotype 1 HCV, including those with compensated cirrhosis. The primary endpoint was sustained virologic response at 12 weeks after the end of therapy (SVR12). For our analysis, rates of SVR12, treatment\u2010emergent adverse events, and graded laboratory abnormalities were analyzed in black versus non\u2010black patients. Of the 1949 patients evaluated, 308 (16%) were black. On average, black patients were older, had higher body mass index, were more likely to be\n                    <jats:italic toggle=\"yes\">IL28B<\/jats:italic>\n                    non\u2010CC, and had a lower serum alanine aminotransferase at baseline than non\u2010black patients. Overall, 95% of black and 97% of non\u2010black patients achieved SVR12. The rate of relapse was 3% in black patients as compared with 2% in non\u2010black patients. The most common adverse events included fatigue, headache, nausea, and insomnia. The majority of adverse events occurred more frequently in the ribavirin\u2010containing arms of the studies. No differences were observed in overall safety by race.\n                    <jats:italic toggle=\"yes\">Conclusion<\/jats:italic>\n                    : A once\u2010daily dosage of ledipasvir\/sofosbuvir was similarly effective in black and non\u2010black patients with genotype 1 HCV infection. The addition of ribavirin did not appear to increase SVR12 but was associated with higher rates of adverse events. (H\n                    <jats:sc>epatology<\/jats:sc>\n                    2016;63:437\u2013444)\n                  <\/jats:p>","DOI":"10.1002\/hep.28334","type":"journal-article","created":{"date-parts":[[2015,11,8]],"date-time":"2015-11-08T13:54:12Z","timestamp":1446990852000},"page":"437-444","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":51,"title":["Safety and efficacy of ledipasvir\u2010sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data"],"prefix":"10.1097","volume":"63","author":[{"given":"Julius M.","family":"Wilder","sequence":"first","affiliation":[{"name":"Duke Clinical Research Institute,Durham,NC"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lennox J.","family":"Jeffers","sequence":"additional","affiliation":[{"name":"Miami VA Medical Center,Miami,FL"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natarajan","family":"Ravendhran","sequence":"additional","affiliation":[{"name":"Digestive Disease Associates,Baltimore,MD"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mitchell L.","family":"Shiffman","sequence":"additional","affiliation":[{"name":"Liver Institute of Virginia, Bon Secours Health System, Richmond and Newport News,VA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Poulos","sequence":"additional","affiliation":[{"name":"Fayetteville Gastroenterology Associates, Cumberland Research Associates,Fayetteville,NC"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark S.","family":"Sulkowski","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine,Baltimore,MD"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Norman","family":"Gitlin","sequence":"additional","affiliation":[{"name":"Atlanta Gastroenterology Associates,Atlanta,GA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kimberly","family":"Workowski","sequence":"additional","affiliation":[{"name":"Emory University,Atlanta,GA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yanni","family":"Zhu","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jenny C.","family":"Yang","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Phillip S.","family":"Pang","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John G.","family":"McHutchison","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew J.","family":"Muir","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute,Durham,NC"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles","family":"Howell","sequence":"additional","affiliation":[{"name":"Howard University,Washington,DC"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kris","family":"Kowdley","sequence":"additional","affiliation":[{"name":"Swedish Medical Center,Seattle,WA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nezam","family":"Afdhal","sequence":"additional","affiliation":[{"name":"Beth Israel Deaconess Medical Center,Boston,MA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K. Rajender","family":"Reddy","sequence":"additional","affiliation":[{"name":"University of Pennsylvania School of Medicine,Philadelphia,PA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","published-online":{"date-parts":[[2015,12,18]]},"reference":[{"key":"hep28334-bib-0001-20241017","doi-asserted-by":"crossref","first-page":"558","DOI":"10.1016\/S1473-3099(05)70216-4","article-title":"Global epidemiology of hepatitis C virus infection","volume":"5","year":"2005","journal-title":"The Lancet Infect Dis"},{"issue":"Suppl. 1","key":"hep28334-bib-0002-20241017","first-page":"74","article-title":"The global burden of hepatitis C","volume":"29","year":"2009","journal-title":"Liver Int."},{"key":"hep28334-bib-0004-20241017","doi-asserted-by":"crossref","first-page":"705","DOI":"10.7326\/0003-4819-144-10-200605160-00004","article-title":"The prevalence of hepatitis C virus infection in the United States, 1999 through 2002","volume":"144","year":"2006","journal-title":"Ann Intern Med"},{"key":"hep28334-bib-0006-20241017","doi-asserted-by":"crossref","first-page":"556","DOI":"10.1056\/NEJM199908193410802","article-title":"The prevalence of hepatitis C virus infection in the United States, 1988 through 1994","volume":"341","year":"1999","journal-title":"N Engl J Med"},{"key":"hep28334-bib-0007-20241017","doi-asserted-by":"crossref","first-page":"1317","DOI":"10.1053\/gast.2000.19289","article-title":"The impact of interferon plus ribavirin on response to therapy in black patients with chronic hepatitis C. The International Hepatitis Interventional Therapy Group","volume":"119","year":"2000","journal-title":"Gastroenterology"},{"key":"hep28334-bib-0008-20241017","doi-asserted-by":"crossref","first-page":"2265","DOI":"10.1056\/NEJMoa032502","article-title":"Peginterferon alfa\u20102b and ribavirin for the treatment of chronic hepatitis C in blacks and non\u2010Hispanic whites","volume":"350","year":"2004","journal-title":"N Engl J Med"},{"key":"hep28334-bib-0009-20241017","doi-asserted-by":"crossref","first-page":"470","DOI":"10.1053\/j.gastro.2006.06.008","article-title":"Peginterferon and ribavirin treatment in African American and Caucasian American patients with hepatitis C genotype 1","volume":"131","year":"2006","journal-title":"Gastroenterology"},{"key":"hep28334-bib-0010-20241017","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1016\/j.jhep.2011.12.029","article-title":"A phase 1, randomized, placebo\u2010controlled, 3\u2010day, dose\u2010ranging study of GS\u20105885, an NS5A inhibitor, in patients with genotype 1 hepatitis C","volume":"57","year":"2012","journal-title":"J Hepatol"},{"key":"hep28334-bib-0012-20241017","doi-asserted-by":"crossref","first-page":"1889","DOI":"10.1056\/NEJMoa1402454","article-title":"Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection","volume":"370","year":"2014","journal-title":"N Engl J Med"},{"key":"hep28334-bib-0013-20241017","doi-asserted-by":"crossref","first-page":"1483","DOI":"10.1056\/NEJMoa1316366","article-title":"Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection","volume":"370","year":"2014","journal-title":"N Engl J Med"},{"key":"hep28334-bib-0014-20241017","doi-asserted-by":"crossref","first-page":"1879","DOI":"10.1056\/NEJMoa1402355","article-title":"Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis","volume":"370","year":"2014","journal-title":"N Engl J Med"},{"key":"hep28334-bib-0015-20241017","doi-asserted-by":"crossref","first-page":"705","DOI":"10.1056\/NEJMoa1501315","article-title":"Ledipasvir and sofosbuvir for HCV in patients coinfected with HIV\u20101","volume":"373","year":"2015","journal-title":"N Engl J Med"}],"container-title":["Hepatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fhep.28334","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fhep.28334","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/hep.28334","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/hep.28334","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.lww.com\/01515467-201602000-00016","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,10,17]],"date-time":"2024-10-17T19:33:10Z","timestamp":1729193590000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.lww.com\/01515467-201602000-00016"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,12,18]]},"references-count":12,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2016]]}},"URL":"https:\/\/doi.org\/10.1002\/hep.28334","relation":{"has-review":[{"id-type":"doi","id":"10.3410\/f.725921477.793511189","asserted-by":"object"}]},"ISSN":["0270-9139","1527-3350"],"issn-type":[{"value":"0270-9139","type":"print"},{"value":"1527-3350","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,12,18]]},"assertion":[{"value":"2015-08-08","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2015-11-05","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}