Efficacy and safety of sofosbuvir-velpatasvir and sofosbuvir-velpatasvir-voxilaprevir for hepatitis C in Korea: a Phase 3b studyopen access
- Authors
- Heo, Jeong; Kim, Yoon Jun; Lee, Sung Wook; Lee, Youn-Jae; Yoon, Ki Tae; Byun, Kwan Soo; Jung, Yong Jin; Tak, Won Young; Jeong, Sook-Hyang; Kwon, Kyung Min; Suri, Vithika; Wu, Peiwen; Jang, Byoung Kuk; Lee, Byung Seok; Cho, Ju-Yeon; Jang, Jeong Won; Yang, Soo Hyun; Paik, Seung Woon; Kim, Hyung Joon; Kwon, Jung Hyun; Park, Neung Hwa; Kim, Ju Hyun; Kim, In Hee; Ahn, Sang Hoon; Lim, 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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