Sofosbuvir: Difference between revisions

Sofosbuvir was discovered in 2007 by [[Michael J. Sofia]], a scientist at [[Pharmasset]], and the drug was first tested in people in 2010. In 2011, [[Gilead Sciences]] bought Pharmasset for about $11 billion.<ref name=NewYorker/> Gilead submitted the [[New Drug Application]] for sofosbuvir in combination with [[ribavirin]] in April 2013, and in October 2013 it received the FDA's [[Breakthrough therapy|Breakthrough Therapy Designation]].<ref name=FDAreview>{{cite web|title=Application Number: 204671Orig1s000: Medical Reviews|url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000MedR.pdf|publisher=FDA|date=November 20, 2013|url-status=live|archive-url=https://web.archive.org/web/20161110175252/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000MedR.pdf|archive-date=November 10, 2016 }}</ref> In December 2013, the [[FDA]] approved sofosbuvir in combination with ribavirin for oral dual therapy of [[Hepatitis C virus#Genotypes|HCV genotypes]] 2 and 3, and for triple therapy with injected [[pegylated interferon]] (pegIFN) and RBV for treatment-naive people with HCV genotypes 1 and 4.<ref name=FDA2013>{{cite web | url = https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm377888.htm | title = FDA approves Sovaldi for chronic hepatitis C | date = 2013-12-06 | work = FDA New Release | publisher = U.S. Food and Drug Administration | url-status = live | archive-url = https://web.archive.org/web/20131209000157/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377888.htm | archive-date = 2013-12-09 }}</ref><ref name="medscape">{{cite web| url = http://www.medscape.com/viewarticle/817371| title = FDA Approves 'Game Changer' Hepatitis C Drug Sofosbuvir| author = Tucker M| date = December 6, 2013| website = Medscape| url-status = live| archive-url = https://web.archive.org/web/20150517012529/http://www.medscape.com/viewarticle/817371| archive-date = May 17, 2015}}</ref> Two months before, the FDA had approved another drug, [[simeprevir]], as a hepatitis C treatment.<ref name=FDA2013/>