兰州大学机构库
Efficacy and safety of alfosbuvir plus daclatasvir in Chinese patients with hepatitis C virus genotypes 1, 2, 3, and 6 infection: An open-label, phase 2 study
2022-04-01
Online publication date2022-04
Source PublicationJOURNAL OF VIRAL HEPATITIS   Impact Factor & Quartile Of Published Year  The Latest Impact Factor & Quartile
ISSN1352-0504
EISSN1365-2893
Volume29Issue:6Pages:455-464
page numbers10
AbstractAlfosbuvir is a novel potent HCV NS5B polymerase inhibitor in development for the treatment of chronic HCV infection. Our previous studies indicated that alfosbuvir monotherapy was well-tolerated and druggable in healthy subjects and HCV-infected patients. Here, we evaluate the efficacy and safety of alfosbuvir in combination with daclatasvir in Chinese patients with HCV genotype 1, 2, 3 or 6. In this open-label study, patients with chronic HCV infection were randomly assigned with a 1:1:1 ratio to receive 12 weeks of daclatasvir 60 mg plus alfosbuvir at a dose of 400, 600 or 800 mg (Cohort A, B or C) daily. Randomization was stratified by HCV genotype and the presence or absence of cirrhosis at screening. The primary endpoint was a sustained virologic response 12 weeks after the end of treatment (SVR12). A total of 124 patients were enrolled in the study, all of whom were available for post-treatment week 12 assessments. SVR12 was achieved in 92.7% (38/41), 95.2% (40/42) and 100% (41/41) of patients in Cohort A, B and C respectively. The most common adverse events were hepatic steatosis, upper respiratory tract infection, hypercholesterolaemia, hypertriglyceridaemia, blood bilirubin increased, and total bile acids increased. There were no discontinuations due to adverse events, and no treatment-related serious adverse events were reported. Once-daily oral administration of alfosbuvir plus daclatasvir were highly effective and safe in Chinese patients infected with HCV genotype 1, 2, 3 or 6, suggesting this regimen could be a promising drug candidate for HCV treatment irrespective of genotype. (ClinicalTrials.gov number, NCT04070235).
Keywordalfosbuvir China daclatasvir hepatitis C virus pan-genotypic
PublisherWILEY
DOI10.1111/jvh.13650
Indexed BySCIE
Language英语
WOS Research AreaGastroenterology & Hepatology ; Infectious Diseases ; Virology
WOS SubjectGastroenterology & Hepatology ; Infectious Diseases ; Virology
WOS IDWOS:000779241800001
Original Document TypeArticle ; Early Access
PMID 35080256
Citation statistics
Document Type期刊论文
Identifierhttps://ir.lzu.edu.cn/handle/262010/481045
Collection兰州大学
第二临床医学院
Corresponding AuthorNiu, Junqi
Affiliation
1.First Hosp Jilin Univ, Changchun, Peoples R China;
2.Liuzhou Peoples Hosp, Liuzhou, Peoples R China;
3.Second Hosp Nanjing, Nanjing, Peoples R China;
4.940th Hosp Joint Logist Support Force PLA, Lanzhou, Peoples R China;
5.Sixth Peoples Hosp Shenyang, Shenyang, Peoples R China;
6.Capital Med Univ, Beijing Friendship Hosp, Beijing, Peoples R China;
7.Third Peoples Hosp Zhenjiang, Zhenjiang, Jiangsu, Peoples R China;
8.Cent South Univ, Xiangya Hosp, Changsha, Peoples R China;
9.Cent South Univ, Xiangya Hosp 1, Changsha, Peoples R China;
10.Guangzhou Eighth Peoples Hosp, Guangzhou, Peoples R China;
11.Lanzhou Univ, Hosp 2, Lanzhou, Peoples R China;
12.Shanghai Publ Hlth Clin Ctr, Shanghai, Peoples R China;
13.Qingdao Municipal Hosp, Qingdao, Peoples R China;
14.Shulan Hangzhou Hosp, Hangzhou, Peoples R China;
15.Capital Med Univ, Beijing Youan Hosp, Beijing, Peoples R China;
16.Zhengzhou Sixth Peoples Hosp, Zhengzhou, Peoples R China;
17.Nanjing Sanhome Pharmaceut Co Ltd, Nanjing, Peoples R China;
18.Xinjiang Med Univ, Hosp 1, Urumqi, Peoples R China
Recommended Citation
GB/T 7714
Hua, Rui,Kong, Fei,Wen, Xiaofeng,et al. Efficacy and safety of alfosbuvir plus daclatasvir in Chinese patients with hepatitis C virus genotypes 1, 2, 3, and 6 infection: An open-label, phase 2 study[J]. JOURNAL OF VIRAL HEPATITIS,2022,29(6):455-464.
APA Hua, Rui.,Kong, Fei.,Wen, Xiaofeng.,Xiong, Qingfang.,Chen, Jiayu.,...&Niu, Junqi.(2022).Efficacy and safety of alfosbuvir plus daclatasvir in Chinese patients with hepatitis C virus genotypes 1, 2, 3, and 6 infection: An open-label, phase 2 study.JOURNAL OF VIRAL HEPATITIS,29(6),455-464.
MLA Hua, Rui,et al."Efficacy and safety of alfosbuvir plus daclatasvir in Chinese patients with hepatitis C virus genotypes 1, 2, 3, and 6 infection: An open-label, phase 2 study".JOURNAL OF VIRAL HEPATITIS 29.6(2022):455-464.
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