兰州大学机构库
Alfosbuvir plus Daclatasvir for Treatment of Chronic Hepatitis C Virus Infection in China
2023-10-19
Online publication date2023-10
Source PublicationInfectious Diseases and Therapy   Impact Factor & Quartile
ISSN2193-8229 ; 2193-6382
EISSN2193-6382
page numbers15
AbstractIntroduction: A pan-genotypic and effective treatment regimen for patients with chronic hepatitis C virus (HCV) infection remains an unmet medical need in China. Alfosbuvir is a novel potent HCV NS5B polymerase inhibitor in development for the treatment of chronic HCV infection. We conducted a phase 3 study to evaluate the efficacy and safety of alfosbuvir in combination with daclatasvir in Chinese patients with HCV infection.Methods: All patients received 600 mg alfosbuvir tablets plus 60 mg daclatasvir tablets once daily for 12 weeks. The primary endpoint was sustained virological response 12 weeks after the end of treatment (SVR12). A follow-up visit was done at week 4 and 12, and those who achieved SVR12 were followed up at post-treatment week 24.Results: Of the 326 patients who received at least one dose of the study drug, 320 (98.2% [95% confidence interval (CI): 96.5%-99.5%]) achieved sustained virological response at post-treatment week 12 (SVR12), which was superior to the historical SVR12 rate of 88% (p < 0.0001). The SVR12 rates were similar regardless of most baseline characteristics. The most common adverse event (AE) (>= 10%) was hypercholesterolemia. Serious adverse events (SAEs) were reported in 25 (7.7%) patients, none of which was judged to be related to the study drug. The majority of AEs were mild to moderate in severity.Conclusions: Alfosbuvir plus daclatasvir for 12 weeks was highly effective and safe in Chinese patients infected with HCV genotype 1, 2, 3, or 6, suggesting that this regimen could be a promising option for HCV treatment in China irrespective of genotype.
KeywordAlfosbuvir Daclatasvir Hepatitis C virus China
PublisherSPRINGER LONDON LTD
DOI10.1007/s40121-023-00872-4
Indexed BySCIE
Language英语
WOS Research AreaInfectious Diseases
WOS SubjectInfectious Diseases
WOS IDWOS:001087762500001
Original Document TypeArticle ; Early Access
PMID 37856013
Citation statistics
Document Type期刊论文
Identifierhttps://ir.lzu.edu.cn/handle/262010/568231
Collection兰州大学
Corresponding AuthorWei, Lai; Niu, Junqi
Affiliation
1.First Hosp Jilin Univ, Ctr Infect Dis & Pathogen Biol, State Key Lab Zoonot Dis, Key Lab Organ Regenerat & Transplantat,Minist Educ, Changchun, Peoples R China;
2.Beijing Tsinghua Changgung Hosp, Beijing, Peoples R China;
3.Sixth Peoples Hosp Zhengzhou, Zhengzhou, Peoples R China;
4.Liuzhou Peoples Hosp, Liuzhou, Peoples R China;
5.Xinjiang Med Univ, Affiliated Hosp 1, Urumqi, Peoples R China;
6.Sichuan Prov Peoples Hosp, Chengdu, Sichuan, Peoples R China;
7.Sixth Peoples Hosp Shenyang, Shenyang 110005, Liaoning, Peoples R China;
8.Capital Med Univ, Beijing Ditan Hosp, Beijing, Peoples R China;
9.Cent South Univ, Xiangya Hosp 2, Changsha, Peoples R China;
10.Xinjiang Uygur Autonomous Reg Hosp Tradit Chinese, Urumqi, Peoples R China;
11.Yanbian Univ, Affiliated Hosp, Yanbian, Peoples R China;
12.Cent South Univ, Xiangya Hosp, Changsha, Peoples R China;
13.Army Mil Med Univ, Affiliated Hosp 1, Chongqing, Peoples R China;
14.Shanghai Publ Hlth Clin Ctr, Shanghai, Peoples R China;
15.Guangzhou Eighth Peoples Hosp, Guangzhou, Peoples R China;
16.Joint Serv Logist Support Force PLA, Hosp 940, Lanzhou, Peoples R China;
17.Zhengzhou Peoples Hosp, Zhengzhou, Peoples R China;
18.Second Hosp Nanjing, Nanjing, Peoples R China;
19.Capital Med Univ, Beijing Friendship Hosp, Beijing, Peoples R China;
20.Xuzhou Med Univ, Affiliated Hosp, Xuzhou, Peoples R China;
21.Peking Univ, Peoples Hosp, Beijing, Peoples R China;
22.Xi An Jiao Tong Univ, Affiliated Hosp 1, Xian, Peoples R China;
23.Fifthth Peoples Hosp Wuxi, Wuxi, Peoples R China;
24.Harbin Med Univ, Affiliated Hosp 4, Harbin, Peoples R China;
25.Lanzhou Univ, Hosp 1, Lanzhou, Peoples R China;
26.Fourth Mil Med Univ PLA, Tangdu Hosp, Xian, Peoples R China;
27.Jiangyin Peoples Hosp, Jiangyin, Peoples R China;
28.Qingdao Municipal Hosp, Qingdao, Peoples R China;
29.Tonghua Cent Hosp, Tonghua, Peoples R China;
30.Foshan First Peoples Hosp, Foshan, Peoples R China;
31.Capital Med Univ, Beijing Youan Hosp, Beijing, Peoples R China;
32.Shulan Hangzhou Hosp, Hangzhou, Peoples R China;
33.Third Peoples Hosp Zhenjiang, Zhenjiang, Peoples R China;
34.Joint Logist Support Force PLA, Hosp 900, Fuzhou, Peoples R China;
35.Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Wuhan, Peoples R China;
36.Guangxi Med Univ, Affiliated Hosp 1, Nanning, Peoples R China;
37.Nanjing Sanhome Pharmaceut Co Ltd, Nanjing, Peoples R China
Recommended Citation
GB/T 7714
Hua, Rui,Kong, Fei,Li, Guangming,et al. Alfosbuvir plus Daclatasvir for Treatment of Chronic Hepatitis C Virus Infection in China[J]. Infectious Diseases and Therapy,2023.
APA Hua, Rui.,Kong, Fei.,Li, Guangming.,Wen, Xiaofeng.,Zhang, Yuexin.,...&Niu, Junqi.(2023).Alfosbuvir plus Daclatasvir for Treatment of Chronic Hepatitis C Virus Infection in China.Infectious Diseases and Therapy.
MLA Hua, Rui,et al."Alfosbuvir plus Daclatasvir for Treatment of Chronic Hepatitis C Virus Infection in China".Infectious Diseases and Therapy (2023).
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