FDA. US: The U.S. Food and Drug Administration today approved Viekira Pak
(ombitasvir, paritaprevir and ritonavir tablets co-packaged with
dasabuvir tablets) to treat patients with chronic hepatitis C virus
(HCV) genotype 1 infection, including those with a type of advanced
liver disease called cirrhosis.
Hepatitis C is a viral disease
that causes inflammation of the liver that can lead to reduced liver
function, liver failure or liver cancer. Most people infected with HCV
have no symptoms of the disease until liver damage becomes apparent,
which may take decades. 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.
Viekira Pak contains three new
drugs—ombitasvir, paritaprevir and dasabuvir—that work together to
inhibit the growth of HCV. It also contains ritonavir, a previously
approved drug, which is used to increase blood levels of paritaprevir.
Viekira Pak can be used with or without ribavirin, but it is not
recommended for patients whose liver is unable to function properly
(decompensated cirrhosis).
“The new generation of therapeutics for
hepatitis C virus is 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. “We continue to see the development of new
all-oral treatments with very high virologic response rates and improved
safety profiles compared to some of the older interferon-based drug
regimens.”
Viekira Pak is the fourth drug product approved by the
FDA in the past year to treat chronic HCV infection. The FDA approved
Olysio (simeprevir) in November 2013, Sovaldi (sofosbuvir) in December
2013 and Harvoni (ledipasvir and sofosbuvir) in October 2014.
Viekira
Pak’s efficacy was evaluated in six clinical trials enrolling 2,308
participants with chronic HCV infection with and without cirrhosis. In
different trials, participants were randomly assigned to receive Viekira
Pak or placebo (sugar pill); Viekira Pak with or without ribavirin; or
Viekira Pak with ribavirin for 12 or 24 weeks.
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. Results from multiple populations, including
those considered difficult to treat, showed 91 to 100 percent of
participants who received Viekira Pak at the recommended dosing achieved
SVR. The recommended dosing for Viekira Pak is two ombitasvir,
paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once
daily and one dasabuvir 250 mg tablet twice daily.
The most common
side effects reported in clinical trial participants were feeling
tired, itching, feeling weak or lack of energy, nausea and trouble
sleeping.
Viekira Pak is the eleventh new drug product 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. Viekira Pak 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.
Viekira Pak is
marketed by AbbVie Inc., based in North Chicago, Illinois. Olysio is
marketed by Raritan, New Jersey-based Janssen Pharmaceuticals. Sovaldi
and Harvoni are marketed by Gilead Sciences, based in Foster City,
California.
The 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.