The U.S. Food and Drug Administration today approved Harvoni
(ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV)
genotype 1 infection.
Harvoni is the first combination pill approved to treat chronic HCV
genotype 1 infection. It is also the first approved regimen that does
not require administration with interferon or ribavirin, two
FDA-approved drugs also used to treat HCV infection.
Both drugs in Harvoni interfere with the enzymes needed by HCV to
multiply. Sofosbuvir is a previously approved HCV drug marketed under
the brand name Sovaldi. Harvoni also contains a new drug called
ledipasvir.
“With the development and approval of new treatments for hepatitis C
virus, we are changing the treatment paradigm for Americans living with
the disease,” said Edward Cox, M.D., M.P.H., director of the Office of
Antimicrobial Products in the FDA’s Center for Drug Evaluation and
Research. “Until last year, the only available treatments for hepatitis C
virus required administration with interferon and ribavirin. Now,
patients and health care professionals have multiple treatment options,
including a combination pill to help simplify treatment regimens.”
Harvoni is the third drug approved by the FDA in the past year to
treat chronic HCV infection. The FDA approved Olysio (simeprevir) in
November 2013 and Sovaldi in December 2013.
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