{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T18:16:42Z","timestamp":1791829002157,"version":"4.3.4"},"reference-count":31,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,7,14]],"date-time":"2024-07-14T00:00:00Z","timestamp":1720915200000},"content-version":"vor","delay-in-days":13,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Sofosbuvir\/Velpatasvir (SOF\/VEL) is a combination drug used for chronic hepatitis C (HCV) infection. However, limited information exists regarding the pharmacokinetics of SOF\/VEL and its metabolites in hemodialysis patients. We conducted a prospective investigation of the pharmacokinetic parameters of SOF\/VEL after a single dose of SOF\/VEL (400\/100\u2009mg) on days with and without dialysis in 12 Thai hemodialysis patients with chronic HCV infection, who had been undergoing hemodialysis for a duration of 0.5\u201320\u2009years. Blood samples were collected before dose (0) and 0.5, 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, and 12.0\u2009h after dose. Dialysate samples were also collected before dose (0) and 1.0, 2.0, 3.0, and 4.0\u2009h after dose. Plasma and dialysate samples were quantified for SOF and its metabolite, GS\u2010331007, and VEL concentrations using a fully validated LCMS technique. In addition, a preliminary efficacy study was conducted using the proposed SOF\/VEL dose reduction regimen in all patients. No differences in SOF\/VEL PK parameters between on\u2010 and off\u2010dialysis studies. On the contrary, GS\u2010331007 exhibited a 30% reduction in the area under the plasma concentration\u2013time curve from time 0 to 24\u2009h (AUC<jats:sub>0\u201024h<\/jats:sub>) on dialysis days compared with non\u2010dialysis days (AUC<jats:sub>0\u201024h<\/jats:sub> ratio 0.68 vs. 1.04, respectively). The dialysis clearance of SOF and GS\u2010331007 was 9.35 (8.72\u201315.11) and 8.89 (8.52\u201314.07) mL\/min, respectively. Subsequently, an alternate\u2010day regimen of SOF\/VEL (400\/100\u2009mg) was administered for 12\u2009weeks, resulting in an undetectable plasma HCV viral load without side effects. Further clinical studies are warranted to validate the efficacy and safety of our proposed dose reduction regimen.<\/jats:p>","DOI":"10.1111\/cts.13884","type":"journal-article","created":{"date-parts":[[2024,7,15]],"date-time":"2024-07-15T04:13:45Z","timestamp":1721016825000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Pharmacokinetics of Sofosbuvir\/Velpatasvir and efficacy of an alternate\u2010day treatment in hemodialysis patients with chronic hepatitis C infection"],"prefix":"10.1111","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1096-6020","authenticated-orcid":false,"given":"Pajaree","family":"Chariyavilaskul","sequence":"first","affiliation":[{"name":"Center of Excellence in Clinical Pharmacokinetics and Pharmacogenomics, Faculty of Medicine Chulalongkorn University  Bangkok Thailand"},{"name":"Department of Pharmacology, Faculty of Medicine Chulalongkorn University  Bangkok 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Faculty of Medicine Chulalongkorn University  Bangkok Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sookruethai","family":"Lekhyananda","sequence":"additional","affiliation":[{"name":"The Kidney Foundation of Thailand  Bangkok Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2992-4050","authenticated-orcid":false,"given":"Wisit","family":"Prasithsirikul","sequence":"additional","affiliation":[{"name":"Department of Disease Control, Bamrasnaradura Infectious Institute Ministry of Public Health  Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4374-251X","authenticated-orcid":false,"given":"Thananda","family":"Trakarnvanich","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Vajira Hospital Navamindradhiraj University  Bangkok 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