Sofosbuvir: First Global Approval

被引:91
作者
Keating, Gillian M. [1 ]
Vaidya, Asha [2 ]
机构
[1] Adis Int Ltd, Auckland 10, New Zealand
[2] Adis R&D Insight, Auckland 0754, New Zealand
关键词
TREATMENT-NAIVE PATIENTS; HEPATITIS-C INFECTION; DRUG-DRUG INTERACTION; HIGH SVR RATES; HCV GENOTYPE 1; PLUS RIBAVIRIN; IN-VITRO; GS-7977; HEALTHY; RESISTANCE;
D O I
10.1007/s40265-014-0179-7
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Sofosbuvir (Solvadi (TM)), a nucleotide analogue hepatitis C virus NS5B polymerase inhibitor, is under development with Gilead Sciences for the once-daily, oral treatment of chronic hepatitis C. Oral sofosbuvir has been approved in the US for the treatment of chronic hepatitis C as a component of a combination antiviral regimen. In addition, the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of sofosbuvir for the treatment of chronic hepatitis C. This article summarizes the milestones in the development of sofosbuvir leading to this first approval for chronic hepatitis C.
引用
收藏
页码:273 / 282
页数:10
相关论文
共 37 条
[1]   Sofosbuvir-based interferon-free therapy for patients with HCV infection [J].
Asselah, Tarik .
JOURNAL OF HEPATOLOGY, 2013, 59 (06) :1342-1345
[2]  
Charlton MR, 2013, HEPATOLOGY, V58, p1378A
[3]  
Curry MP, 2013, HEPATOLOGY, V58, p314A
[4]   Nucleotide Polymerase Inhibitor Sofosbuvir plus Ribavirin for Hepatitis C [J].
Gane, Edward J. ;
Stedman, Catherine A. ;
Hyland, Robert H. ;
Ding, Xiao ;
Svarovskaia, Evguenia ;
Symonds, William T. ;
Hindes, Robert G. ;
Berrey, M. Michelle .
NEW ENGLAND JOURNAL OF MEDICINE, 2013, 368 (01) :34-44
[5]  
German P, 2013, HEPATOLOGY, V58, p433A
[6]  
German P, 2012, HEPATOLOGY, V56, p1072A
[7]  
Gilead Sciences Inc, 2013, EUR CHMP AD POS OP G
[8]  
Gilead Sciences Inc, 2013, US FOOD DRUG ADM APP
[9]  
Gilead Sciences Inc, 2013, SOLV SOF TABL OR US
[10]   ANALYSIS OF THE KINETICS OF VIRAL DECLINE DURING 14 DAYS OF ADMINISTRATION OF SOFOSBUVIR AND GS-0938 [J].
Guedj, J. ;
Pang, P. S. ;
Lawitz, E. ;
Rodriguez-Torres, M. ;
Symonds, B. ;
Perelson, A. S. .
JOURNAL OF HEPATOLOGY, 2013, 58 :S486-S487