miércoles, 20 de julio de 2016

EPCLUSA: New Drug Trials Snapshot Posted


EPCLUSA is a drug for the treatment of adults who have a specific type of Hepatitis C virus (HCV) infection, called chronic Hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection.
EPCLUSA is a combination of two anti-viral drugs: sofosbuvir (previously approved for HCV treatment) and velpatasvir (new drug for HCV). It is intended to be used as follows:
  • EPLCUSA alone in patients who do not have cirrhosis or who have an early stage cirrhosis
  • EPCLUSA in combination with another approved HCV drug called ribavirin in patients who have advanced cirrhosis
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to decreased liver function, cirrhosis, liver failure, liver cancer or death.
Drug Trials Snapshots provide information about who participated in clinical trials that supported the FDA approval of new drugs. The information provided in these Snapshots also highlights whether there were any differences in the benefits and side effects among sex, race and age groups.
See more Drug Trial Snapshots or contact us with questions at Snapshots@fda.hhs.gov.

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