AbbVie to profit from new Viekira Pak uses

FDA expanded the use of ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets without ribavirin (Viekira Pak, AbbVie) this week to treat patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A).

Until now, Viekira Pak has only been approved in the United States for chronic hepatitis C virus (HCV) genotype 1 infection, including in patients with cirrhosis.

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The expanded use of Viekira Pak comes just in time for AbbVie, which faces increased competition from Zepatier (Merck & Co.), which was recently approved by FDA and is priced around 30% lower than Viekira Pak and the other leading hepatitis C medications, Harvoni and Sovaldi (both Gilead Sciences). AbbVie executives slashed their 2016 sales estimate for Viekira Pak from $3 billion to $2 billion late last year.

FDA  approved the supplemental New Drug Application (sNDA) for Viekira Pak after an AbbVie study found that patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and Child-Pugh A receiving 12 weeks of treatment were cured-without the need for ribavirin, according to Jordan J. Feld, MD, research director and clinician scientist and the study’s lead investigator at the Toronto Center for Liver Disease in Toronto, Canada.

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"This approval is especially significant because patients with chronic HCV with compensated cirrhosis are among the tough to treat, and in our study Viekira Pak demonstrated 100 percent cure rates in GT1b patients without the use of ribavirin,” said Michael Severino, MD, executive vice president, research and development and chief scientific officer, AbbVie.

In addition, the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for Viekirax (ombitasvir/ paritaprevir/ ritonavir tablets) + Exviera (dasabuvir tablets) in late February. This RBV-free option is now approved for use for the treatment of chronic HCV infected GT1b patients with compensated cirrhosis (Child-Pugh A) in Europe.

The CDC estimates that approximately 2.7 million Americans are chronically infected with HCV. Genotype 1 is the most common HCV in the United States. 

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