{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T17:49:09Z","timestamp":1788544149736,"version":"build-2803163510"},"reference-count":40,"publisher":"Korean Association of Internal Medicine","issue":"4","license":[{"start":{"date-parts":[[2023,6,30]],"date-time":"2023-06-30T00:00:00Z","timestamp":1688083200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences, Inc.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["kjim.org"],"crossmark-restriction":true},"short-container-title":["Korean J Intern Med"],"published-print":{"date-parts":[[2023,7,1]]},"abstract":"<jats:p>Background\/Aims: Despite the availability of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection in Korea, need remains for pangenotypic regimens that can be used in the presence of hepatic impairment, comorbidities, or prior treatment failure. We investigated the efficacy and safety of sofosbuvir\u2013velpatasvir and sofosbuvir\u2013velpatasvir\u2013voxilaprevir for 12 weeks in HCV-infected Korean adults. Methods: This Phase 3b, multicenter, open-label study included 2 cohorts. In Cohort 1, participants with HCV genotype 1 or 2 and who were treatment-naive or treatment-experienced with interferon-based treatments, received sofosbuvir\u2013velpatasvir 400\/100 mg\/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor-containing regimen \u2265 4 weeks received sofosbuvir\u2013velpatasvir\u2013voxilaprevir 400\/100\/100 mg\/day. Decompensated cirrhosis was an exclusion criterion. The primary endpoint was SVR12, defined as HCV RNA &lt; 15 IU\/mL 12 weeks following treatment. Results: Of 53 participants receiving sofosbuvir\u2013velpatasvir, 52 (98.1%) achieved SVR12. The single participant who did not achieve SVR12 experienced an asymptomatic Grade 3 ASL\/ALT elevation on day 15 and discontinued treatment. The event resolved without intervention. All 33 participants (100%) treated with sofosbuvir\u2013velpatasvir\u2013voxilaprevir achieved SVR 12. Overall, sofosbuvir\u2013velpatasvir and sofosbuvir\u2013velpatasvir\u2013voxilaprevir were safe and well tolerated. Three participants (5.6%) in Cohort 1 and 1 participant (3.0%) in Cohort 2 had serious adverse events, but none were considered treatment-related. No deaths or grade 4 laboratory abnormalities were reported. Conclusions: Treatment with sofosbuvir\u2013velpatasvir or sofosbuvir\u2013velpatasvir\u2013voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients.<\/jats:p>","DOI":"10.3904\/kjim.2022.252","type":"journal-article","created":{"date-parts":[[2023,6,30]],"date-time":"2023-06-30T08:28:52Z","timestamp":1688113732000},"page":"504-513","update-policy":"https:\/\/doi.org\/10.3904\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Efficacy and safety of sofosbuvir\u2013velpatasvir and sofosbuvir\u2013velpatasvir\u2013voxilaprevir for hepatitis C in Korea: a Phase 3b study"],"prefix":"10.3904","volume":"38","author":[{"given":"Jeong","family":"Heo","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoon Jun","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sung 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