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.
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.
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
“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.”
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.
Hepatitis C is a viral disease that
causes inflammation of the liver that can lead to diminished liver
function or liver failure. Most people infected with HCV have no
symptoms of the disease until liver damage becomes apparent, which may
Some people with chronic HCV infection develop
scarring and poor liver function (cirrhosis) over many years, which can
lead to complications such as bleeding, jaundice (yellowish eyes or
skin), fluid accumulation in the abdomen, infections and liver cancer.
According to the Centers for Disease Control and Prevention, about 3.2
million Americans are infected with HCV, and without proper treatment,
15-30 percent of these people will go on to develop cirrhosis.
efficacy was evaluated in three clinical trials enrolling 1,518
participants who had not previously received treatment for their
infection (treatment-naive) or had not responded to previous treatment
(treatment-experienced), including participants with cirrhosis.
Participants were randomly assigned to receive Harvoni with or without
ribavirin. The trials were designed to measure whether the hepatitis C
virus was no longer detected in the blood at least 12 weeks after
finishing treatment (sustained virologic response, or SVR), indicating
that a participant’s HCV infection has been cured.
In the first
trial, comprised of treatment-naive participants, 94 percent of those
who received Harvoni for eight weeks and 96 percent of those who
received Harvoni for 12 weeks achieved SVR. The second trial showed 99
percent of such participants with and without cirrhosis achieved SVR
after 12 weeks. And in the third trial, which examined Harvoni’s
efficacy in treatment-experienced participants with and without
cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99
percent of those who received Harvoni for 24 weeks achieved SVR. In all
trials, ribavirin did not increase response rates in the participants.
The most common side effects reported in clinical trial participants were fatigue and headache.
is the seventh new drug with breakthrough therapy designation to
receive FDA approval. The FDA can designate a drug as a breakthrough
therapy at the request of the sponsor if preliminary clinical evidence
indicates the drug may demonstrate a substantial improvement over
available therapies for patients with serious or life-threatening
diseases. Harvoni was reviewed under the FDA’s priority review program,
which provides for an expedited review of drugs that treat serious
conditions and, if approved, would provide significant improvement in
safety or effectiveness.
Harvoni and Sovaldi are marketed by
Gilead, based in Foster City, California. Olysio is marketed by Janssen
Pharmaceutical based in Raritan, New Jersey.
FDA Press Release Source:
Labels: FDA approval of Harvoni