What is the role of Viekira Pak in the treatment of hepatitis C virus (HCV) infection?

Updated: Dec 09, 2020
  • Author: David C Wolf, MD, FACP, FACG, AGAF, FAASLD; Chief Editor: Michael Stuart Bronze, MD  more...
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Answer

Answer

In December 2014, the FDA approved for patients with genotype 1 infection the combination of paritaprevir (an NS3/4A protease inhibitor), ritonavir (a protease inhibitor that functions as a CYP3A inhibitor to boost the level of paritaprevir), ombitasvir (an NS5A replication complex inhibitor), and dasabuvir (a non-nucleoside NS5B polymerase inhibitor).

This combination, known by the brand name Viekira Pak or as PrOD (in the American Association for the Study of Liver Diseases/Infectious Diseases Society of America [AASLD/IDSA] guidelines), is often used in combination with ribavirin. It is FDA approved for use in noncirrhotic patients and in patients with compensated cirrhosis. Studies were conducted using two tablets of paritaprevir/ritonavir/ombitasvir once daily (in the morning) plus one tablet of dasabuvir 250 mg twice daily (morning and evening) with a meal with ribavirin (up to 6 pills divided into two daily doses) for 12 weeks (no cirrhosis or compensated cirrhosis with genotype 1b infection) or 24 weeks (compensated cirrhosis with genotype 1a infection). SVR rates of 89-99% were reported, depending on the genotype subtype and the presence of cirrhosis. [16, 17, 18, 19, 20]

The Viekira Pak package insert was amended in October 2015. Several cases of hepatic decompensation and death were reported after PrOD therapy was initiated in patients with moderate to severe hepatic impairment (Child-Pugh B and C). The use of PrOD is now contraindicated in these groups. [21]


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