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US Approves Breakthrough Hepatitis C Drug, Sofosbuvir

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Sovaldi_Sofosbuvir_Hepatatis C-Gilead_400 mg tablets in 28-count bottle

 

WASHINGTON, Dec. 6, 2013 (AP) — Federal health officials have approved a highly anticipated hepatitis C drug from Gilead Sciences Inc. that is expected to offer a faster, more palatable cure to millions of people infected with the liver-destroying virus.

The Food and Drug Administration said Friday it approved the pill Sovaldi in combination with older drugs to treat the main forms of hepatitis C that affect U.S. patients.

Current treatments for hepatitis C can take up to a year of therapy and involve weekly injections of a drug that causes flu-like side effects. That approach only cures about three out of four patients. Sovaldi is a daily pill that in clinical trials cured roughly 90 percent of patients in just 12 weeks, when combined with the older drug cocktail.http://www.pharmalive.com/us-approves-breakthrough-hepatitis-c-drug

 

Product name: Sovaldi 
Common name: Sofosbuvir 
Alias: GS-7977, PSI-7977 
Chinese name: Sophia Bouvet (Suofabuwei, cable release Wei) 
CAS Registry Number :1190307 -88-0 

The chemical structure 

Chemical Structure of Sovaldi_Sofosbuvir_Hepatatis C-Gilead
Indications: Chronic hepatitis C (HCV GT1, GT2, GT3, GT4) 
Mechanism: nucleoside NS5B polymerase inhibitor 
approved Time: December 6, 2013 
, U.S. Patent Number: 7964580,8415322,8334270,7429572;, patent validity: March 26, 2029 (U.S. Patent No.: 7,964,580 and 8,334,270), April 3, 2025 (U.S. Patent No.: 7,429,572 and 8,415,322) Sales value (estimated): $ 1.9 billion (2014), 6600000000 USD (2016) Drug Companies: Gilead Sciences, Inc. (Gilead Sciences)

GS-7977, (S)-isopropyl 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4- dihydropyrimidin^l(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2- yl)methoxy)(phenoxy)phosphoryl)amino)propanoate, available from Gilead Sciences, Inc., is described and claimed in U.S. Patent No. 7,964,580. (See also US 2010/0016251, US 2010/0298257, US 201 1/0251 152 and US 2012/0107278.) GS-7977 has the structure:

 

Figure imgf000013_0001

GS-7977 can be crystalline or amorphous. Examples of preparing crystalline and amorphous forms of GS-7977 are disclosed in US 2010/0298257 (US 12/783,680) and US 201 1/0251 152 (US 13/076,552), both of which are incorporated by reference.

 

 

Gilead hepatitis C drug Sophia Bouvet (Sovaldi, Sofosbuvir) preparation methods Synthesis of Sovaldi_Sofosbuvir_GS-7977_PSI-7977_Hepatitis C_Gilead

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