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HCV Protease Inhibitor Simeprevir Granted FDA Priority Review Status
On May 13, Janssen announced that its application for approval of the next-generation hepatitis C virus NS3/4A protease inhibitor simeprevir (formerly TMC435) has received priority review status from the U.S. Food and Drug Administration (FDA), giving it an estimated timeline of 6 months.
EASL 2013: Anemia Is a Common Side Effect of First-generation HCV Protease Inhibitors
About half of patients taking boceprevir (Victrelis) or telaprevir (Incivek or Incivo) developed anemia and approximately one-third experienced skin rash, but sustained response rates were high in an analysis of a population representative of people with chronic hepatitis C in North America, researchers reported at the EASL International Liver Congress (EASL 2013) last month in Amsterdam.
EASL 2013: Triple Therapy for Hepatitis C Is Effective after Liver Transplantation but Comes with Side Effects
Adding the approved HCV protease inhibitor telaprevir (Incivek or Incivo) to pegylated interferon and ribavirin can increase sustained response rates even for difficult-to-treat liver transplant recipients, but adverse events are common, researchers reported at the EASL International Liver Congress (EASL 2013) last month in Amsterdam.
EASL 2013: Compassionate Access to New Hepatitis C Drugs Is an 'Emergency' for European Patients
European governments must move quickly to ensure that compassionate use arrangements are put into place to allow access to new hepatitis C drugs for people with cirrhosis, advocates and doctors said at the EASL International Liver Congress (EASL 2013) in Amsterdam last week. However, clear differences in opinion emerged between patients and doctors regarding who should make decisions about acceptable levels of risk to patients during a symposium on compassionate use organized by the European Liver Patients Association.
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