{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T13:23:43Z","timestamp":1762867423315,"version":"3.37.3"},"reference-count":32,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2018,5,14]],"date-time":"2018-05-14T00:00:00Z","timestamp":1526256000000},"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":["Liver International"],"published-print":{"date-parts":[[2018,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background &amp; Aims<\/jats:title><jats:p>There is scant data on use of sofosbuvir containing directly acting antiviral (<jats:styled-content style=\"fixed-case\">DAA<\/jats:styled-content>) regimens in chronic kidney disease (<jats:styled-content style=\"fixed-case\">CKD<\/jats:styled-content>) patients. Recently generic versions of <jats:styled-content style=\"fixed-case\">DAA<\/jats:styled-content>s have become available in low\u2010income countries including India. The aim of this study was to study the efficacy and safety of generic sofosbuvir in combination with generic ribavirin, ledipasvir or daclatasvir in <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content>\u2010infected patients with <jats:styled-content style=\"fixed-case\">CKD<\/jats:styled-content> including patients with advanced <jats:styled-content style=\"fixed-case\">CKD<\/jats:styled-content> (<jats:styled-content style=\"fixed-case\">CKD<\/jats:styled-content> stage 4 or 5 with an estimated glomerular filtration rate (<jats:styled-content style=\"fixed-case\">GFR<\/jats:styled-content>) &lt;30 <jats:styled-content style=\"fixed-case\">mL<\/jats:styled-content>\/min or those on dialysis).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Seventy\u2010one <jats:styled-content style=\"fixed-case\">CKD<\/jats:styled-content> patients (76% male, 84.5% on maintenance haemodialysis, 23.9% cirrhosis) with <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> infection were included in the study. Full\u2010dose sofosbuvir was used in combination with ribavirin (n\u00a0=\u00a026, for 24 weeks, 69.2% genotype 1, 30.8% genotype 3), ledipasvir (n\u00a0=\u00a026, for 12\u00a0weeks, all genotype 1) and daclatasvir (n\u00a0=\u00a019, for 12\u00a0weeks, all genotype 3).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Sustained virological response (<jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>) (<jats:styled-content style=\"fixed-case\">HCV RNA <\/jats:styled-content><jats:bold>&lt;<\/jats:bold>12 <jats:styled-content style=\"fixed-case\">IU<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">mL<\/jats:styled-content>) at 12 weeks after stopping treatment was seen in 100% of the patients in all the 3 groups. At 24\u2010week follow\u2010up after end of therapy, 1 patient in sofosbuvir plus ledipasvir group relapsed. At 48\u2010week follow\u2010up after end of therapy, 1 more patient in sofosbuvir plus ribavirin group relapsed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Full\u2010dose sofosbuvir\u2010based <jats:styled-content style=\"fixed-case\">DAA<\/jats:styled-content> therapy using generics is highly effective for individuals with <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> infection and <jats:styled-content style=\"fixed-case\">CKD<\/jats:styled-content> including advanced <jats:styled-content style=\"fixed-case\">CKD<\/jats:styled-content> (<jats:styled-content style=\"fixed-case\">CKD<\/jats:styled-content> stage 4 or 5 with an e\u2010<jats:styled-content style=\"fixed-case\">GFR<\/jats:styled-content> &lt;30 <jats:styled-content style=\"fixed-case\">mL<\/jats:styled-content>\/min or those on dialysis).<\/jats:p><\/jats:sec>","DOI":"10.1111\/liv.13863","type":"journal-article","created":{"date-parts":[[2018,4,20]],"date-time":"2018-04-20T14:19:43Z","timestamp":1524233983000},"page":"2137-2148","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Generic sofosbuvir\u2010based direct\u2010acting antivirals in hepatitis C virus\u2010infected patients with chronic kidney disease"],"prefix":"10.1111","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3448-8334","authenticated-orcid":false,"family":"Manoj Kumar","sequence":"first","affiliation":[{"name":"Department of Hepatology and Liver Transplatation Institute of Liver and Biliary Sciences  New Delhi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suman L.","family":"Nayak","sequence":"additional","affiliation":[{"name":"Department of Nephrology Institute of Liver and Biliary Sciences  New Delhi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ekta","family":"Gupta","sequence":"additional","affiliation":[{"name":"Department of Virology Institute of Liver and Biliary Sciences  New Delhi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ashish","family":"Kataria","sequence":"additional","affiliation":[{"name":"Department of Nephrology Institute of Liver and Biliary Sciences  New Delhi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0544-5610","authenticated-orcid":false,"given":"Shiv K.","family":"Sarin","sequence":"additional","affiliation":[{"name":"Department of Hepatology and Liver Transplatation Institute of Liver and Biliary Sciences  New Delhi India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,5,14]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2008.06.003"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2893.2007.00868.x"},{"key":"e_1_2_9_4_1","unstructured":"Gilead Sciences Inc.Sovaldi 400\u00a0mg tablets (sofosbuvir) product monograph 2014.http:\/\/www.gilead.ca\/pdf\/ca\/sovaldi_pm_english.pdf. 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