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Efficacy and safety of sofosbuvir-velpatasvir and sofosbuvir-velpatasvir-voxilaprevir for hepatitis C in Korea: a Phase 3b studyopen access

Authors
Heo, JeongKim, Yoon JunLee, Sung WookLee, Youn-JaeYoon, Ki TaeByun, Kwan SooJung, Yong JinTak, Won YoungJeong, Sook-HyangKwon, Kyung MinSuri, VithikaWu, PeiwenJang, Byoung KukLee, Byung SeokCho, Ju-YeonJang, Jeong WonYang, Soo HyunPaik, Seung WoonKim, Hyung JoonKwon, Jung HyunPark, Neung HwaKim, Ju HyunKim, In HeeAhn, Sang HoonLim, Young-Suk
Issue Date
Jul-2023
Publisher
대한내과학회
Keywords
Direct -acting antiviral; Decompensated cirrhosis; NS5A inhibitor; Polymerase inhibitor; Protease inhibitor
Citation
The Korean Journal of Internal Medicine, v.38, no.4, pp 504 - +
Indexed
SCIE
SCOPUS
KCI
Journal Title
The Korean Journal of Internal Medicine
Volume
38
Number
4
Start Page
504
End Page
+
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/65089
DOI
10.3904/kjim.2022.252
ISSN
1226-3303
2005-6648
Abstract
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-velpatasvir and sofosbuvir-velpatasvir-voxila-previr 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-velpat-asvir 400/100 mg/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor -contain-ing regimen >= 4 weeks received sofosbuvir-velpatasvir-voxilaprevir 400/100/100 mg/day. Decompensated cirrhosis was an exclusion criterion. The primary endpoint was SVR12, defined as HCV RNA < 15 IU/mL 12 weeks following treatment.Results: Of 53 participants receiving sofosbuvir-velpatasvir, 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-velpatasvir-voxilaprevir achieved SVR 12. Overall, sofosbuvir-velpatasvir and sofosbuvir-velpatasvir-voxilaprevir 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-velpatasvir or sofosbuvir-velpatasvir-voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients.
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Byun, Kwan Soo
Guro Hospital (Department of Gastroenterology and Hepatology, Guro Hospital)
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