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www.fdanews.com/articles/171903-abbvies-hep-c-cocktail-viekira-pak-successful-in-cirrhosis-patients-without-ribavirin

AbbVie’s Hep C Cocktail Viekira Pak Successful in Cirrhosis Patients Without Ribavirin

June 30, 2015

AbbVie’s hepatitis C drug combo Viekira Pak was 100 percent effective in patients with genotype 1b and liver cirrhosis without the additional use of the antiviral ribavirin, the company said last week.

Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets), inhibits the growth of hepatitis C and may be combined with ribavirin. However, when the patient’s liver is heavily scarred, ribavirin is not recommended.

All of the patients in the Turquoise-III study achieved a 100 percent cure rate, showing a sustained response to the standalone Viekira Pak treatment after 12 weeks of treatment, AbbVie says.

The FDA approved the drug cocktail in December under a breakthrough therapy designation, based on clinical trials involving 2,308 patients with chronic hepatitis C, both with and without cirrhosis. 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.  

Genotype 1 is the most common type of hepatitis C, accounting for 60 percent of cases worldwide. Of those, about 10 percent to 20 percent go on to develop liver complications, including cirrhosis. — Kellen Owings