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FDA Expands Labeling for Viekira Pak to Include Treatment of Genotype 1b HCV in Patients With Cirrhosis
The FDA has given the nod to a supplemental new drug application (sNDA) for the use of Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child–Pugh class A). The application was previously granted a priority review.
Ombitasvir is an HCV NS5A inhibitor; paritaprevir is an HCV NS3/4A protease inhibitor; ritonavir is a cytochrome P450-3A inhibitor; and dasabuvir is an HCV non-nucleoside NS5B palm polymerase inhibitor.
Viekira Pak is used with or without RBV to treat adults with genotype 1 chronic HCV infection and can now be used in patients with compensated cirrhosis. The treatment is not intended for patients with advanced (decompensated) cirrhosis.
The Centers for Disease Control and Prevention estimates that approximately 2.7 million people in the United States are chronically infected with HCV. Genotype 1 is the most common HCV in the U.S. Of the total U.S. population with GT1 HCV infection, approximately 77% are genotype 1a (GT1a) and 23% are GT1b.
The TURQUOISE-III trial, included in the sNDA, was a phase 3b multicenter, open-label, single-arm study to evaluate the safety and efficacy of 12 weeks of treatment with Viekira Pak without RBV in 60 adults with chronic GT1b HCV infection and compensated liver cirrhosis (Child-Pugh A) who were treatment-naïve or treatment-experienced (i.e., they had failed previous therapy with pegylated interferon and RBV). The study’s primary endpoint was the rate of sustained virological response at 12 weeks after treatment (SVR12).
The results demonstrated a 100% (60/60) SVR12. Patients who achieve an SVR12 are considered cured of HCV, as the virus is no longer detectable in the blood. No patients discontinued treatment because of adverse events. The most common adverse events included fatigue (22%), diarrhea (20%), headache (18%), arthralgia (10%), dizziness (10%), insomnia (10%), and pruritus (10%).3
In the U.S., Viekira Pak is indicated for the treatment of adult patients with chronic genotype 1b hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis, or in adult patients with chronic genotype 1a HCV without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.
Sources: AbbVie; April 25, 2016; and Viekira Pak Prescribing Information; April 2016.