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`FDA Approves 'Game Changer' Hepatitis C Drug Sofosbuvir
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`News > Medscape Medical News > FDA Approvals
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`FDA Approves 'Game Changer' Hepatitis C Drug
`Sofosbuvir
`
`Miriam E. Tucker
`DISCLOSURES | December 06, 2013
`
`https://www.medscape.com/viewarticle/817371
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`4/10
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`Gilead 2006
`I-MAK v. Gilead
`IPR2018-00125
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`1
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`11/2/2017
`FDA Approves 'Game Changer' Hepatitis C Drug Sofosbuvir
`The US Food and Drug Administration (FDA) has approved the first-in-kind nucleotide analog
`inhibitor sofosbuvir (Sovaldi, Gilead Sciences, Inc) for the treatment of adults with chronic
`hepatitis C virus (HCV) infection, a widely anticipated move that is expected to dramatically
`improve outcomes for many patients.
`
`Data presented earlier this year at an FDA advisory committee meeting support the use of
`sofosbuvir in combination with ribavirin (RBV) for all-oral dual therapy of infections with HCV
`genotypes 2 and 3, as well as in triple therapy along with injected pegylated interferon
`(pegIFN) and RBV for treatment-naive patients with HCV genotypes 1 and 4.
`
`The availability of the first all-oral, interferon-free regimen is a first and a major advance,
`experts say.
`
`"This is a very exciting time in liver diseases," Greg Fitz, MD, president of the American
`Association for the Study of Liver Diseases, said at a news conference held last month during
`The Liver Meeting 2013, at which sofosbuvir was discussed extensively and new data were
`presented.
`
`"I think the move away from interferon and toward a high probability of success is remarkably
`encouraging for all of us.... Suddenly, it's realistic to think we can cure most patients with
`hepatitis C," Dr. Fitz told reporters.
`
`"Sofosbuvir is a game-changer and will allow high cure rates with just 12-week regimens,"
`David R. Nelson, MD, assistant vice president for research, professor of medicine, and
`associate dean of clinical research at the College of Medicine, University of Florida,
`Gainesville, told Medscape Medical News.
`
`Indeed, liver expert Norah A. Terrault, MD, told Medscape Medical News that sofosbuvir holds
`numerous advantages over current therapy because of its efficacy profile, safety, and
`tolerability across many different patient populations and HCV genotypes, as well as its dosing
`simplicity.
`
`"And of course, the first all-oral option for patients with HCV is also a large step forward in
`terms of principal, to show that you can eradicate HCV without interferon being part of the
`treatment cocktail.... It's a huge and major advance," said Dr. Terrault, professor of medicine
`and surgery and director of the Viral Hepatitis Center at the University of California, San
`Francisco.
`
`Data supporting licensure for sofosbuvir came from 6 clinical trials consisting of 1947
`participants, some in trials of sofosbuvir plus RBV with HCV genotype 2 or 3 (including both
`treatment-naive patients and those who had failed or could not tolerate previous therapy) and
`others taking the triple combination of sofosbuvir, RBV, and pegIFN in 3 treatment-naive
`patients infected with HCV genotypes 1, 4, 5, or 6.
`
`At the advisory committee hearing, Gilead scientists reported sustained viral clearance at 12
`weeks (SVR12) ranging from 89% to 95% for genotype 2 and 61% to 63% for genotype 3. For
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`https://www.medscape.com/viewarticle/817371
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`FDA Approves 'Game Changer' Hepatitis C Drug Sofosbuvir
`11/2/2017
`HCV genotype 1, which accounts for about 70% of all HCV in the United States, sofosbuvir-
`based triple therapy including pegIFN produced an SVR12 of 89%.
`
`Dr. Terrault noted that although there has been a published trial showing efficacy of sofosbuvir
`and RBV without IFN for HCV genotype 1, the SVR12 was inferior to the triple therapy
`regimen.
`
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`Cite this article: FDA Approves 'Game Changer' Hepatitis C Drug Sofosbuvir - Medscape - Dec 06, 2013.
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`What to Read Next on Medscape
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