Gilead Sciences GILD today announced that the company has submitted
a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)
for approval of sofosbuvir, a once-daily oral nucleotide analogue for the
treatment of chronic hepatitis C virus (HCV) infection. The data submitted in
this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral
therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir
in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve
patients with genotype 1, 4, 5 and 6 HCV infection.
Chronic HCV infection affects up to four million Americans, particularly
individuals born between 1946 and 1964. The disease is the leading cause of
liver cancer and liver transplantation in the United States. Treatment for HCV
currently includes 24-48 weeks of therapy with peg-IFN, which has to be
injected and is associated with significant side effects, leaving some
patients unable to complete therapy. If approved, sofosbuvir would shorten HCV
therapy to 12 to 16 weeks, and depending on the genotype, would either
eliminate or reduce the duration of peg-IFN injections.
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