{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T11:10:51Z","timestamp":1784718651076,"version":"3.55.0"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,6,12]],"date-time":"2021-06-12T00:00:00Z","timestamp":1623456000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,6,12]],"date-time":"2021-06-12T00:00:00Z","timestamp":1623456000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Gastroenterol"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Introduction<\/jats:title>\n                <jats:p>Real-world data regarding the impact of hepatic fibrosis on the effectiveness of sofosbuvir\/velpatasvir (SOF\/VEL) treatment is limited in the Asian population.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>We analyzed data for all 823 patients with hepatitis C virus treated with SOF\/VEL from June 2019 to September 2020 at Chang Gung Memorial Hospital in Chiayi, Taiwan. The degree of fibrosis was determined using the fibrosis-4 (FIB-4) index, with advanced fibrosis or cirrhosis defined as a FIB-4 score of\u2009&gt;\u20093.25. The primary treatment outcome was the rate of sustained virologic response 12\u00a0weeks after treatment cessation (SVR). Adverse events (AEs) were also evaluated.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>SVR rates did not significantly differ (<jats:italic>p<\/jats:italic>\u2009&gt;\u20090.05) between patients with FIB-4 scores of\u2009\u2264\u20093.25 and those with scores of\u2009&gt;\u20093.25. In the per protocol analysis, 99.2% (593\/598) of the FIB-4\u2009\u2264\u20093.25 group and 100% (172\/172) of the FIB-4\u2009&gt;\u20093.25 group achieved SVR; in the evaluable population analysis, 93.4% (593\/635) of the FIB-4\u2009\u2264\u20093.25 group and 91.5% (172\/188) of the FIB-4\u2009&gt;\u20093.25 group achieved SVR. Five patients with FIB-4 scores of\u2009\u2264\u20093.25 did not attain SVR: two relapsed and three had no response. The most common AEs were comparable (<jats:italic>p<\/jats:italic>\u2009&gt;\u20090.05) for the FIB-4\u2009\u2264\u20093.25 group and the FIB-4\u2009&gt;\u20093.25 group and included abdominal discomfort (4.4% vs. 5.9%), fatigue (4.1% vs. 5.9%), and skin itching (3.6% vs. 3.2%). Laboratory abnormalities were more common in the FIB-4\u2009&gt;\u20093.25 group (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). Six patients with FIB-4 scores of\u2009&gt;\u20093.25 had total bilirubin elevation\u2009&gt;\u20093\u2009\u00d7\u2009the upper normal limit (UNL). Alanine transaminase elevation\u2009&gt;\u20095\u2009\u00d7\u2009the UNL was observed in two patients with FIB-4 scores of\u2009\u2264\u20093.25 and one patient with a FIB-4 score of\u2009&gt;\u20093.25. No AEs resulted in treatment discontinuation.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>SOF\/VEL treatment is well tolerated and achieves high SVR rates for patients of Taiwanese ethnicity with HCV, regardless of cirrhosis status.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12876-021-01837-y","type":"journal-article","created":{"date-parts":[[2021,6,12]],"date-time":"2021-06-12T13:02:53Z","timestamp":1623502973000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Sofosbuvir\/velpatasvir is an effective treatment for patients with hepatitis C and advanced fibrosis or cirrhosis in a real-world setting in Taiwan"],"prefix":"10.1186","volume":"21","author":[{"given":"Yu-Ting","family":"Huang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yung-Yu","family":"Hsieh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei-Ming","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shui-Yi","family":"Tung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kuo-Liang","family":"Wei","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chen-Heng","family":"Shen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kao-Chi","family":"Chang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chung-Kuang","family":"Lu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chih-Wei","family":"Yen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheng-Nan","family":"Lu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chao-Hung","family":"Hung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Te-Sheng","family":"Chang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,6,12]]},"reference":[{"key":"1837_CR1","doi-asserted-by":"publisher","first-page":"122","DOI":"10.1038\/nrgastro.2016.176","volume":"14","author":"AP Thrift","year":"2017","unstructured":"Thrift AP, El-Serag HB, Kanwal F. Global epidemiology and burden of HCV infection and HCV-related disease. Nat Rev Gastroenterol Hepatol. 2017;14:122\u201332.","journal-title":"Nat Rev Gastroenterol Hepatol"},{"key":"1837_CR2","doi-asserted-by":"publisher","first-page":"469","DOI":"10.1093\/infdis\/jis385","volume":"206","author":"MH Lee","year":"2012","unstructured":"Lee MH, Yang HI, Lu SN, Jen CL, You SL, Wang LY, et al. Chronic hepatitis C virus infection increases mortality from hepatic and extrahepatic diseases: a community-based long-term prospective study. J Inf Dis. 2012;206:469\u201377.","journal-title":"J Inf Dis"},{"key":"1837_CR3","unstructured":"World Health Organization. Global Hepatitis Report 2017. Geneva: World Health Organization. 2017. http:\/\/www.who.int\/hepatitis\/publications\/global-hepatitis-report2017\/en. Accessed 20 Feb 2021."},{"key":"1837_CR4","doi-asserted-by":"publisher","first-page":"161","DOI":"10.1016\/S2468-1253(16)30181-9","volume":"2","author":"S Blach","year":"2017","unstructured":"Blach S, Zeuzem S, Manns M, Altraif I, DuBerg AS, Muljono DH, et al. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol. 2017;2:161\u201376.","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"1837_CR5","doi-asserted-by":"publisher","first-page":"S95","DOI":"10.1016\/j.jhep.2016.07.039","volume":"65","author":"AJ Van der Meer","year":"2016","unstructured":"Van der Meer AJ, Berenguer M. Reversion of disease manifestations after HCV eradication. J Hepatol. 2016;65:S95\u2013108.","journal-title":"J Hepatol"},{"key":"1837_CR6","doi-asserted-by":"publisher","first-page":"637","DOI":"10.7326\/M16-2575","volume":"166","author":"O Falade-Nwulia","year":"2017","unstructured":"Falade-Nwulia O, Suarez-Cuervo C, Nelson DR, Fried MW, Segal JB, Sulkowski MS. Oral direct-acting agent therapy for hepatitis C virus infection: a systematic review. Ann Intern Med. 2017;166:637\u201348.","journal-title":"Ann Intern Med"},{"key":"1837_CR7","unstructured":"Global Hepatitis Report 2017. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO. http:\/\/www.who.int\/hepatitis\/publications\/global-hepatitis-report2017\/en\/. Accessed 20 Feb 2021."},{"key":"1837_CR8","doi-asserted-by":"publisher","first-page":"666","DOI":"10.1016\/j.jhep.2019.06.002","volume":"71","author":"E De Gasperi","year":"2019","unstructured":"De Gasperi E, Spinetti A, Lombardi A, Landonio S, Scotton PG, Pasulo L, et al. Effectiveness and safety of sofosbuvir\/velpatasvir\/voxiaprevir in patients with chronic hepatitis C previously treated with DAAs. J Hepatol. 2019;71:666\u201372.","journal-title":"J Hepatol"},{"issue":"7","key":"1837_CR9","doi-asserted-by":"publisher","first-page":"e0199941","DOI":"10.1371\/journal.pone.0199941","volume":"13","author":"N Miotto","year":"2018","unstructured":"Miotto N, Mendes LC, Zanaga LP, Lazarini MSK, Goncales ESL, Pedro MN, et al. All-oral direct antiviral treatment for hepatitis C chronic infection in a real-life cohort: the role of cirrhosis and comorbidities in treatment response. PLoSONE. 2018;13(7):e0199941. https:\/\/doi.org\/10.1371\/journal.pone.0199941.","journal-title":"PLoSONE"},{"key":"1837_CR10","doi-asserted-by":"publisher","first-page":"307","DOI":"10.3851\/IMP3061","volume":"22","author":"A Arias","year":"2017","unstructured":"Arias A, Aguilera A, Soriano V, Benitez-Gutierrez L, Liedo G, Navarro D, et al. Rate and predictors of treatment failure to all-oral HCV regimens outside clinical trials. Antivir Res. 2017;22:307\u201312.","journal-title":"Antivir Res"},{"key":"1837_CR11","doi-asserted-by":"publisher","first-page":"44","DOI":"10.1177\/1060028016668897","volume":"51","author":"EB Chahine","year":"2017","unstructured":"Chahine EB, Sucher AJ, Hemstreet BA. Sofosbuvir\/velpatasvir: the first pangenotypic direct-acting antiviral combination for hepatitis C. Ann Pharmacother. 2017;51:44\u201353.","journal-title":"Ann Pharmacother"},{"key":"1837_CR12","doi-asserted-by":"publisher","first-page":"1841","DOI":"10.1111\/liv.14537","volume":"40","author":"A Mangia","year":"2020","unstructured":"Mangia A, Milligan S, Khalili M, Fagiuoli S, Shafran SD, Carrat F, et al. Global real-world evidence of sofosbuvir\/velpatasvir as simple, effective HCV treatment: analysis of 5552 patients from 12 cohorts. Liver Int. 2020;40:1841\u201352.","journal-title":"Liver Int"},{"key":"1837_CR13","doi-asserted-by":"publisher","first-page":"127","DOI":"10.1016\/S2468-1253(18)30343-1","volume":"4","author":"L Wei","year":"2019","unstructured":"Wei L, Lim SG, Xie Q, Van KN, Piratvisuth T, Huang Y, et al. ofosbuvir\u2013velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial. Lancet Gastrenterol Hepatol. 2019;4:127\u201334.","journal-title":"Lancet Gastrenterol Hepatol"},{"issue":"3","key":"1837_CR14","doi-asserted-by":"publisher","first-page":"ofaa055","DOI":"10.1093\/ofid\/ofaa055","volume":"7","author":"J Wilton","year":"2020","unstructured":"Wilton J, Wong S, Yu A, Ramji A, Cook D, Butt ZA, et al. Real-world effectiveness of sofosbuvir\/velpatasvir for treatment of chronic hepatitis C in British Columbia, Canada: a population-based cohort study. Open Forum Infect Dis. 2020;7(3):ofaa055.","journal-title":"Open Forum Infect Dis"},{"key":"1837_CR15","doi-asserted-by":"publisher","first-page":"466","DOI":"10.1016\/S1473-3099(19)30170-7","volume":"19","author":"DS Chen","year":"2019","unstructured":"Chen DS. Taiwan commits to eliminating hepatitis C in 2025. Lancet Infect Dis. 2019;19:466\u20137.","journal-title":"Lancet Infect Dis"},{"key":"1837_CR16","doi-asserted-by":"publisher","first-page":"866","DOI":"10.1111\/jvh.13305","volume":"27","author":"WN Chiu","year":"2020","unstructured":"Chiu WN, Hung CH, Lu SN, Chen MY, Tung SY, Wei KL, et al. Real-world effectiveness of glecaprevir\/pibrentasvir and ledipasvir\/sofosbuvir for mixed genotype hepatitis C infection: a multicenter pooled analysis in Taiwan. J Viral Hepat. 2020;27:866\u201372.","journal-title":"J Viral Hepat"},{"key":"1837_CR17","doi-asserted-by":"publisher","first-page":"1477","DOI":"10.1093\/cid\/ciy585","volume":"67","author":"AASLD-IDSA HCV Guidance Panel","year":"2018","unstructured":"AASLD-IDSA HCV Guidance Panel. Hepatitis C guidance 2018 update: AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus infection. Clin Infect Dis. 2018;67:1477\u201392.","journal-title":"Clin Infect Dis"},{"key":"1837_CR18","doi-asserted-by":"publisher","first-page":"32","DOI":"10.1002\/hep.21669","volume":"46","author":"A Vallet-Pichard","year":"2007","unstructured":"Vallet-Pichard A, Mallet V, Nalpas B, Verkarre V, Nalpas A, Dhalluin-Venier V, et al. FIB-4: an inexpensive and accurate marker of fibrosis in HCV infection. Comparison with liver biopsy and FibroTest. Hepatology. 2007;46:32\u20136.","journal-title":"Hepatology"},{"key":"1837_CR19","doi-asserted-by":"publisher","first-page":"298","DOI":"10.1177\/1756283X15587481","volume":"8","author":"BP Lam","year":"2015","unstructured":"Lam BP, Jeffers T, Younoszai Z, Fazel Y, Younossi ZM. The changing landscape of hepatitis C virus therapy: focus on interferon-free treatment. Ther Adv Gastroenterol. 2015;8:298\u2013312.","journal-title":"Ther Adv Gastroenterol"},{"key":"1837_CR20","doi-asserted-by":"publisher","first-page":"100237","DOI":"10.1016\/j.eclinm.2019.12.007","volume":"18","author":"MJ Zoratti","year":"2020","unstructured":"Zoratti MJ, Siddiqua A, Morassut RE, Zeraatkar D, Chou R, van Holten J, et al. Pangenotypic direct acting antivirals for the treatment of chronic hepatitis C virus infection: a systematic literature review and meta-analysis. EClinicalMedicine. 2020;18:100237.","journal-title":"EClinicalMedicine"},{"key":"1837_CR21","doi-asserted-by":"publisher","first-page":"161","DOI":"10.1007\/s12072-016-9776-8","volume":"11","author":"R Lee","year":"2017","unstructured":"Lee R, Kottilil S, Wilson E. Sofosbuvir\/velpatasvir: a pangenotypic drug to simplify HCV therapy. Hepatol Int. 2017;11:161\u201370.","journal-title":"Hepatol Int"},{"key":"1837_CR22","doi-asserted-by":"publisher","first-page":"87","DOI":"10.1007\/s00535-018-1503-x","volume":"54","author":"T Takehara","year":"2019","unstructured":"Takehara T, Sakamoto N, Nishiguchi S, Ikeda F, Tatsumi T, Ueno Y, et al. Efficacy and safety of sofosbuvir\u2013velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: an open-label phase 3 trial. J Gastroenterol. 2019;54:87\u201395.","journal-title":"J Gastroenterol"},{"key":"1837_CR23","doi-asserted-by":"publisher","first-page":"660","DOI":"10.1016\/j.jhep.2019.05.028","volume":"71","author":"SM Borgia","year":"2019","unstructured":"Borgia SM, Dearden J, Yoshida EM, Shafran SD, Brown A, Ben-Ari Z, et al. Sofosbuvir\/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis. J Hepatol. 2019;71:660\u20135.","journal-title":"J Hepatol"},{"key":"1837_CR24","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1016\/j.jhep.2016.02.042","volume":"65","author":"ZM Younossi","year":"2016","unstructured":"Younossi ZM, Stepanova M, Feld J, Zeuzem S, Jacobson I, Agarwal K, et al. Sofosbuvir\/velpatasvir improves patient-reported outcomes in HCV patients: results from ASTRAL-1 placebo-controlled trial. J Hepatol. 2016;65:33\u20139.","journal-title":"J Hepatol"},{"issue":"8","key":"1837_CR25","doi-asserted-by":"publisher","first-page":"e0221769","DOI":"10.1371\/journal.pone.0221769","volume":"14","author":"Y Chugh","year":"2019","unstructured":"Chugh Y, Dhiman RK, Premkumar M, Prinja S, Grover GS, Bahuguna P. Real-world cost-effectiveness of pangenotypic sofosbuvir-velpatasvir combination versus genotype dependent directly acting anti-viral drugs for treatment of hepatitis C patients in the universal coverage scheme of Punjab state in India. PLoS ONE. 2019;14(8):e0221769.","journal-title":"PLoS ONE"},{"key":"1837_CR26","doi-asserted-by":"publisher","first-page":"443","DOI":"10.1111\/liv.13534","volume":"38","author":"T Asselah","year":"2018","unstructured":"Asselah T, Bourgeois S, Pianko S, Zeuzem S, Sulkowski M, Foster GR, et al. Sofosbuvir\/velpatasvir in patients with hepatitis C virus genotypes 1\u20136 and compensated cirrhosis or advanced fibrosis. Liver Int. 2018;38:443\u201350.","journal-title":"Liver Int"},{"key":"1837_CR27","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1007\/s12072-016-9760-3","volume":"11","author":"G Shiha","year":"2017","unstructured":"Shiha G, Ibrahim A, Helmy A, Sarin SK, Omata M, Kumar A, et al. Asian-Pacific Association for the Study of the Liver (APASL) consensus guidelines on invasive and non-invasive assessment of hepatic fibrosis: a 2016 update. Hepatol Int. 2017;11:1\u201330.","journal-title":"Hepatol Int"},{"key":"1837_CR28","doi-asserted-by":"publisher","first-page":"3259","DOI":"10.1038\/s41598-017-03589-w","volume":"7","author":"HW Wang","year":"2017","unstructured":"Wang HW, Peng CY, Lai HC, Su WP, Lin CH, Chuang PH, et al. New noninvasive index for predicting liver fibrosis in Asian patients with chronic viral hepatitis. Sci Rep. 2017;7:3259. https:\/\/doi.org\/10.1038\/s41598-017-03589-w.","journal-title":"Sci Rep"},{"key":"1837_CR29","doi-asserted-by":"publisher","first-page":"64","DOI":"10.1093\/cid\/cix224","volume":"65","author":"AA Butt","year":"2017","unstructured":"Butt AA, Ren Y, Lo Re V III, Taddei TH, Kaplan DE. Comparing Child\u2013Pugh, MELD, and FIB-4 to predict clinical outcomes in hepatitis C virus-infected persons: results from ERCHIVES. Clin Inf Dis. 2017;65:64\u201372.","journal-title":"Clin Inf Dis"}],"container-title":["BMC Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12876-021-01837-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12876-021-01837-y\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12876-021-01837-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,6,12]],"date-time":"2021-06-12T13:03:54Z","timestamp":1623503034000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcgastroenterol.biomedcentral.com\/articles\/10.1186\/s12876-021-01837-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,6,12]]},"references-count":29,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["1837"],"URL":"https:\/\/doi.org\/10.1186\/s12876-021-01837-y","relation":{},"ISSN":["1471-230X"],"issn-type":[{"value":"1471-230X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,6,12]]},"assertion":[{"value":"19 April 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"31 May 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 June 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was approved by the Institutional Review Board of Chang Gung Medical Foundation. All patients gave written informed consent prior to the initiation of sofosbuvir\/velpatasvir therapy. This study was conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization for Good Clinical Practice.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no conflicts of interest.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"259"}}