The Food and Drug Administration today approved Daklinza
(daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV)
genotype 3 infections. Daklinza is the first drug that has demonstrated
safety and efficacy to treat genotype 3 HCV infections without the need
for co-administration of interferon or ribavirin, two FDA-approved drugs
also used to treat HCV infection.
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
take several years. 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 or liver cancer.
According to the Centers for Disease Control and Prevention,
approximately 2.7 million Americans are infected with HCV of which,
approximately 10 percent are genotype 3.
provides a new option for patients with genotype 3 HCV, including those
patients who cannot tolerate ribavirin,” said Edward Cox, M.D., director
of the Office of Antimicrobial Products in the FDA’s Center for Drug
Evaluation and Research.
The safety and efficacy of Daklinza in
combination with sofosbuvir were evaluated in a clinical trial of 152
treatment-naive and treatment-experienced participants with chronic HCV
genotype 3 infection. Participants received Daklinza 60 mg plus
sofosbuvir 400 mg once daily for 12 weeks and were monitored for 24
weeks post treatment. The studies were designed to measure whether a
participant’s hepatitis C virus was no longer detected in the blood 12
weeks after finishing treatment (sustained virologic response),
suggesting a participant’s infection had been cured.
showed that 98 percent of the treatment-naive participants with no
cirrhosis of the liver and 58 percent of the treatment-naive
participants with cirrhosis achieved sustained virologic response. Of
the participants who were treatment-experienced, 92 percent with no
cirrhosis of the liver and 69 percent with cirrhosis achieved sustained
virologic response. Daklinza labeling carries a Limitations of Use
statement to inform prescribers that sustained virologic response rates
are reduced in HCV genotype 3 infected patients with cirrhosis.
information was available for approximately 1,900 patients with HCV
treated with the recommended dose of Daklinza in combination with other
anti-HCV drugs in clinical trials. The most common side effects of
Daklinza with sofosbuvir were fatigue and headache.
carries a warning for patients and health care providers that serious
slowing of the heart rate (symptomatic bradycardia) and cases requiring
pacemaker intervention have been reported when amiodarone is
co-administered with sofosbuvir in combination with another HCV
direct-acting antiviral, including Daklinza. Co-administration of
amiodarone with Daklinza in combination with sofosbuvir is not
Daklinza 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.
Daklinza is marketed by Bristol-Myers Squibb, based in Princeton, New Jersey.
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation’s food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.
Press Release Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm
Labels: daklinza + sofosbuvir, FDA Approval, Genotype 3, GT3