Seraprevir and sofosbuvir for treatment of chronic hepatitis C virus infection: A single-arm, open-label, phase 3 trial.

Abstract

BACKGROUND AND AIM:

This single-arm, open-label, multicenter, phase 3 trial evaluated the efficacy and safety of seraprevir, an hepatitis C virus (HCV) nonstructural protein 3/4A (NS3/4A) inhibitor, combined with sofosbuvir for treating Chinese patients with chronic HCV infection without cirrhosis.

METHODS:

Treatment-naive or interferon-experienced adult patients without cirrhosis were treated with a universal, combinational regimen of seraprevir 100 mg, twice daily and sofosbuvir 400 mg, once daily, for 12 or 24 weeks. The primary efficacy endpoint was sustained virologic response at week 12 after treatment (SVR12).

RESULTS:

Overall, 205 patients with genotype 1 HCV infection without cirrhosis were enrolled from 23 sites, 202 of whom completed the full treatment and post-treatment course and 3 discontinued follow-up. In total, 27 patients (13.2%) were interferon experienced. SVR12 was achieved by 201 out of 205 (98.0% [95% CI, 95.1%, 99.5%]) patients, 100.0% of patients with genotype 1a, and 98.0% of genotype 1b. In the other exploratory study, SVR 12 was achieved by 100% patients with genotype 2 (n = 21), genotype 3 (n = 7), and genotype 6 (n = 8). The majority of adverse events were mild to moderate and transient and did not require a specific medical intervention.

CONCLUSIONS:

The all-oral, ribavirin-free regimen of seraprevir and sofosbuvir is an effective and well-tolerated treatment option for Chinese patients mono-infected with HCV, including those with a history of interferon treatment.

• Authors: Fei Kong, Xiaoyu Wen, Xiaofeng Wen, Xiaozhong Wang, Guicheng Wu, Shide Lin, Li Wang, Huichun Xing, Xuebing Yan, Sujun Zheng, Qin Ning, Zheng Wang, Liaoyun Zhang, Jianmei Lin, Zhaowei Tong, Chengyu Huang, Minghua Su, Lixin Tong, Jidong Jia, Yongning Xin, Qingjing Zhu, Jing Wang, Li Chen, Xiaowen Li, Xuegang Wu, Duan Niu, Quan Liu, Wei Wei, Yuexin Zhang, Guangming Li, Junqi Niu
• Journal: Journal of gastroenterology and hepatology (J Gastroenterol Hepatol) Vol. 36 Issue 9 Pg. 2375-2382 (Sep 2021) ISSN: 1440-1746 [Electronic] Australia
• PMID: 33491236 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study)
• Copyright: © 2021 The Authors. Journal of Gastroenterology and Hepatology published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Chemical References

• Antiviral Agents
• Viral Nonstructural Proteins
• Sofosbuvir

Topics

• Adult
• Antiviral Agents (adverse effects)
• China (epidemiology)
• Drug Therapy, Combination
• Genotype
• Hepacivirus (genetics)
• Hepatitis C, Chronic (drug therapy, genetics)
• Humans
• Liver Cirrhosis (epidemiology)
• Sofosbuvir (adverse effects)
• Treatment Outcome
• Viral Nonstructural Proteins (adverse effects, antagonists & inhibitors)