FDA Approves AbbVie’s Hep C Drug Viekira Pak

The FDA has approved AbbVie’s hepatitis C drug Viekira Pak under a breakthrough therapy designation, marking the fourth drug authorized in the past year to treat the chronic liver  infection.

Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets), which is indicated for hepatitis C genotype 1, won approval under the agency’s priority review program, the FDA said.

The therapy combines the previously approved ritonavir with three new drugs to inhibit the growth of hepatitis C, the agency said. Combination with ribavirin is optional, but is not recommended when a patient’s liver is not able to function properly, a condition called decompensated cirrhosis.

Approval was based on multiple clinical trials involving 2,308 patients who have chronic hepatitis C, both with and without cirrhosis, the FDA said. Between 91 percent and 100 percent of patients who received Viekira Pak at the recommended dose showed no hepatitis C in their blood after 12 weeks of treatment.    

In the last year the FDA has approved three other drugs to combat chronic hepatitis C, the agency said. They are Janssen’s Olysio (simeprevir), Gilead’s Sovaldi (sofosbuvir), both blockbusters, and Gilead’s recently approved Harvoni (ledipasvir and sofosbuvir). — Bryan Koenig