{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T23:37:59Z","timestamp":1787614679471,"version":"build-2736575974"},"reference-count":38,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2022,3,2]],"date-time":"2022-03-02T00:00:00Z","timestamp":1646179200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2022,5]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Sofosbuvir, a prodrug nucleoside inhibitor of hepatitis C virus, has a predominant circulating metabolite that is renally eliminated. Whether sofosbuvir is associated with chronic kidney disease (CKD) progression is not well understood.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We performed a retrospective analysis of patients with estimated glomerular filtration rate (eGFR) 30\u201389\u00a0mL\/min\/1.73\u00a0m<jats:sup>2<\/jats:sup> treated with sofosbuvir in 76 Phase 2\/3 registrational trials. We evaluated eGFR at each study visit. Separately, we performed a retrospective analysis of an administrative claims database (IQVIA PharMetrics Plus\u2122) to compare the risk of incident end\u2010stage renal disease (ESRD) associated with the use of sofosbuvir or non\u2010sofosbuvir regimens among patients with CKD using propensity score methods. Exposure, CKD status and outcomes were determined using diagnosis and medication claim codes. Cox proportional hazards methods were used to estimate ESRD risk.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 4642 trial participants with baseline stage 2 CKD (eGFR 60\u201389\u00a0ml\/min\/1.73\u00a0m<jats:sup>2<\/jats:sup>) and 682 trial participants with stage 3 CKD (eGFR 30\u201359\u00a0ml\/min\/1.73\u00a0m<jats:sup>2<\/jats:sup>) mean (SD) eGFR improved from baseline to 4\u00a0weeks post\u2010treatment (+0.7 [9.3] and +2.6 [8.8] ml\/min\/1.73\u00a0m<jats:sup>2<\/jats:sup>, respectively; <jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.001 each). In the second analysis, among 2042 patients with CKD receiving sofosbuvir\u2010based regimens compared to 431 receiving non\u2010sofosbuvir\u2010based regimens, after adjusting for baseline covariates and weighting based on treatment propensity scores, there was no significant difference in risk of ESRD (adjusted HR\u00a0=\u00a00.85, 95% CI: 0.51\u20131.42).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Clinical trial participants with CKD did not experience worsening eGFR during sofosbuvir\u2010based treatment, and sofosbuvir was not associated with an increased risk of ESRD in patients with CKD in a nationally\u2010representative administrative claims database.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.16830","type":"journal-article","created":{"date-parts":[[2022,3,2]],"date-time":"2022-03-02T14:03:30Z","timestamp":1646229810000},"page":"1169-1178","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Sofosbuvir and risk of estimated glomerular filtration rate decline or end\u2010stage renal disease in patients with renal impairment"],"prefix":"10.1111","volume":"55","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2145-6352","authenticated-orcid":false,"given":"Mark","family":"Sulkowski","sequence":"first","affiliation":[{"name":"Johns Hopkins University School of Medicine  Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura E.","family":"Telep","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Colombo","sequence":"additional","affiliation":[{"name":"M Colombo Liver Center San Raffaele Hospital  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francois","family":"Durand","sequence":"additional","affiliation":[{"name":"H\u00f4pital Beaujon University Paris Diderot  Clichy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K. Rajender","family":"Reddy","sequence":"additional","affiliation":[{"name":"Department of Medicine University of Pennsylvania  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Lawitz","sequence":"additional","affiliation":[{"name":"Texas Liver Institute University of Texas Health Science Center  San Antonio Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Bourli\u00e8re","sequence":"additional","affiliation":[{"name":"H\u00e9pato\u2010Gastro\u2010Ent\u00e9rologie H\u00f4pital Saint Joseph  Marseille France"},{"name":"INSERM 1252, IRD, Sciences Economiques &amp; Sociales de la Sant\u00e9 &amp; Traitement de l\u2019Information M\u00e9dicale Aix\u2010Marseille University  Marseille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nelson","family":"Cheinquer","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stacey","family":"Scherbakovsky","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liyun","family":"Ni","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lindsey","family":"Force","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heribert","family":"Ramroth","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anuj","family":"Gaggar","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  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