The U.S. Food and Drug Administration (FDA) approved a new drug to treat the hepatitis C virus (HCV) genotype 1 infection, even in patients with an advanced liver disease known as cirrhosis.
Hepatitis C is a virus that causes inflammation of the liver that can lead to serious conditions such as liver cancer. Many people who have contracted this infection do not experience symptoms until liver cancer has already set in, which can take decades.
The newly-approved Viekira Pak contains three new drugs-ombitasvir, paritaprevir and dasabuvir, which inhibit the growth of HCV. It also contains an optional addition of ritonavir, which works to increase blood levels of paritaprevir.
"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 was tested in six clinical trials encompassing 2,308 participants with chronic HCV infection with and without cirrhosis. These patients were randomly assigned to either take Viekira Pak or placebo (sugar pill); Viekira Pak with or without ribavirin; or the treatment for either 12 or 24 weeks.
The findings showed between 91 and 100 percent of participants who received Viekira Pak at the recommended dosing achieved a sustained virologic response, meaning the condition had been cured.
Viekira Pak was the fourth drug product approved to treat chronic HCV infection by the FDA over the past year.
"The FDA approved Olysio (simeprevir) in November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni (ledipasvir and sofosbuvir) in October 2014," the FDA noted.
