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US FDA approves Viekira Pak to treat genotype 1 chronic hepatitis C

Flint, MichiganFriday, December 26, 2014, 12:00 Hrs  [IST]

Diplomat Pharmacy, the largest independent specialty pharmacy, announced that it will stock Viekira Pak (ombitasvir/paritaprevir/ritonavir tablets; dasabuvir tablets), approved by the US Food and Drug Administration. Viekira Pak is a treatment for genotype 1 chronic hepatitis C infection including those with compensated cirrhosis and will be available through open distribution.

Viekira Pak combines three direct–acting antivirals, each of which targets and inhibits specific HCV proteins of the replication process. The labeled dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 mg/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily for either 12 weeks of therapy, or 24 weeks of therapy depending on the patient population.

According to the Center for Disease Control and Prevention, an estimated 3.2 million people in the United States are living with chronic hepatitis C infection. Left untreated, the disease causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer.

Diplomat patients prescribed Viekira Pak will also receive the benefit of the company's disease management programs. Diplomat's hepatitis C program is dedicated to providing education and support to the patient through 24/7 staff availability, side-effect management, prior authorization coordination and help in securing financial assistance.

Viekira was granted breakthrough therapy designation by the FDA in May 2013, a status indicating that the therapy regimen has shown preliminary clinical evidence that it may yield better results than conventional treatments. Viekira also received priority review status.

 
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