Viekira Pak HCV combo tx gets FDA nod

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The FDA has approved Viekira Pak (ombitasvir, paritaprevir, ritonavir with dasabuvir tablets) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection, including cirrhosis.

The combination medication is comprised of three new agents that work together to inhibit HCV growth. It also contains ritonavir which is used to boost levels of paritaprevir. Viekira Pak can be used with or without ribavirin.

The combination's efficacy was studied in six clinical trials (n=2,308) that enrolled patients with chronic HCV infection with and without cirrhosis. Based on the study's design, patients were randomized to receive Viekira Pak or placebo; Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks.

The study endpoint was sustained virologic response (SVR) at 12 weeks, indicating cure of infection. Across various study populations, 91% to 100% of patients who were treated with Viekira Pak achieved SVR, including patients who were considered difficult to treat.

Viekira Pak was designated breakthrough therapy and was reviewed under the FDA's priority review program. For more information visit FDA.gov.

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