Efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for hepatitis C in Korea: a Phase 3b study

Autor: Jeong Heo, Yoon Jun Kim, Sung Wook Lee, Youn-Jae Lee, Ki Tae Yoon, Kwan Soo Byun, Yong Jin Jung, Won Young Tak, Sook-Hyang Jeong, Kyung Min Kwon, Vithika Suri, Peiwen Wu, Byoung Kuk Jang, Byung Seok Lee, Ju-Yeon Cho, Jeong Won Jang, Soo Hyun Yang, Seung Woon Paik, Hyung Joon Kim, Jung Hyun Kwon, Neung Hwa Park, Ju Hyun Kim, In Hee Kim, Sang Hoon Ahn, Young-Suk Lim
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: The Korean Journal of Internal Medicine, Vol 38, Iss 4, Pp 504-513 (2023)
Druh dokumentu: article
ISSN: 1226-3303
2005-6648
DOI: 10.3904/kjim.2022.252
Popis: 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–voxilaprevir 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–velpatasvir 400/100 mg/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor-containing 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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