Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved December 2014

Specific Treatments:

genotype 1 chronic hepatitis C virus

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General Information

Viekira Pak includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor.

Viekira Pak is specifically indicated for the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection including those with compensated cirrhosis. 

Viekira Pak is supplied as a tablet for oral administration. The recommended dosage is two ombitasvir, paritaprevir, ritonavir 12.5/75/50 mg tablets once daily (in the morning) and one dasabuvir 250 mg tablet twice daily (morning and evening) with a meal without regard to fat or calorie content. For recommended administration in specific hepatitis C populations, please see the drug label.

Clinical Results

FDA Approval

Viekira Pak’s efficacy was evaluated in six clinical trials enrolling 2,308 participants with chronic HCV infection with and without cirrhosis. In different trials, subjects were randomly assigned to receive Viekira Pak or placebo; Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR). Results from multiple populations, including those considered difficult to treat, showed 91 to 100 percent of subjects who received Viekira Pak at the recommended dosing achieved SVR. 

Side Effects

Adverse effects associated with the use of Viekira Pak may include, but are not limited to, the following:

  • fatigue
  • nausea
  • pruritus
  • other skin reactions
  • insomnia
  • asthenia

Mechanism of Action

Viekira Pak includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor.

Additional Information

For additional information regarding Viekira Pak or chronic hepatitis C, please visit www.viekira.com