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The FDA Antiviral
Drugs Advisory Committee will review Gilead's
Sofosbuvir on October 25th and Johnson & Johnson's
Simeprevir on October 24th.
Download background information for Sofosbuvir and Simeprevir prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee.
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Updated
FDA Updates For Sofosbuvir
FDA
Updates For Simeprevir
The FDA is scheduled to decide whether to approve sofosbuvir by December 8th, and simeprevir by November 27th.
FDA Issues Positive Review for Gilead's Sofosbuvir Hepatitis C Drug
FDA: J&J Hepatitis C Drug Cures 80% of Patients
HCV drugs simeprevir, sofosbuvir earn positive FDA reviews before advisory board votes
October 23, 2013
Two hepatitis C drugs, simeprevir and sofosbuvir, received promising internal FDA reviews on the eve of advisory board meetings at which government experts will decide whether to recommend approval for both medications.
A background report submitted to the FDA Antiviral Drugs Advisory Committee concluded that simeprevir (Johnson & Johnson), in combination with pegylated interferon-alpha and ribavirin (PR), was superior to placebo in achieving a sustained virologic response in treatment-naive patients with HCV and those who relapsed after prior PR therapy.
Full Story »
This blog is all about current FDA approved drugs to treat the hepatitis C virus (HCV) with a focus on treating HCV according to genotype, using information extracted from peer-reviewed journals, liver meetings/conferences, and interactive learning activities.
Risk Of Developing Liver Cancer After HCV Treatment
- Home
- Newly Diagnosed With Hep C? Or Considering Treatment?
- All FDA Approved Drugs To Treat Hepatitis C
- Hepatitis C Genotypes and Treatment
- Mavyret (glecaprevir/pibrentasvir)
- Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir)
- Epclusa® (Sofosbuvir/Velpatasvir)
- Harvoni® (Ledipasvir/Sofosbuvir)
- VIEKIRA XR/VIEKIRA Pak
- Zepatier(Elbasvir/Grazoprevir)
- Cure - Achieving sustained virologic response (SVR) in hepatitis C
- HCV Liver Fibrosis
- FibroScan® Understanding The Results
- HCV Cirrhosis
- Staging Cirrhosis
- HCV Liver Cancer
- Risk Of Developing Liver Cancer After HCV Treatment
- Treating Elderly HCV Patients
- Fatty Liver Disease: NAFLD/NASH
- Current research articles on ailments that may be related to HCV
- Is There A Natural Way To Improve Liver Fibrosis?
- Can Food Or Herbs Interact With Conventional Medical Treatments?
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