Viekira Pak was approved by the FDA on December 19, 2015 as the newest treatment for chronic hepatitis C (genotype 1), and is already available to patients. Genotype 1 is the most common in the US, affecting around 75% of Americans with the virus.
Were there any special circumstances for the approval of Viekira Pak?
Yes. Viekira Pak was designated a breakthrough therapy. That means the approval process could be completed faster than usual.
Viekira Pak received this special treatment because it is used to treat a serious condition, hepatitis C, and if approved would provide significant improvement in safety and effectiveness.
What are the other new treatment options for hepatitis C?
Olysio (simeprevir), Sovaldi (sofosbuvir), and Harvoni (ledipasvir/sofosbuvir) were also approved near the end of 2014. All are considered more effective than previous treatments, and all are very expensive.
Be aware that your insurance company may cover only one of these newer hepatitis C medications. For example, Express Scripts is covering only Viekira Pak. This may be good or bad news for you. In this case, Express Scripts is covering Viekira even for patients with less severe symptoms, but limiting choices for you and your prescriber.
What medications are in the combination Viekira Pak?
The Viekira Pak has two types of table with a total of four active ingredients.
The pink tablet within the Pak contains ombitasvir (12.5 mg), paritaprevir (75mg), and ritonavir (50mg). The second beige tablet contains just dasabuvir (250 mg).
How is Viekira taken?
The Viekira tablets are taken with meals as follows:
- 2 pink tablets (containing ombitasvir, paritaprevir, and ritonavir 12.5/75/50 mg) once daily in the morning
- 1 beige tablet (containing dasabuvir 250 mg) twice daily (morning and evening)
How does Viekira Pak work?
Viekira Pak is the only FDA-approved regimen that contains 3 distinct mechanisms of action or ways that attack the hepatitis C virus at various stages in its lifecycle to stop it from multiplying.
What are the most common side effects of Viekira Pak?
The most common side effects of Viekira Pak include itching, nausea, feeling tired, feeling weak or lacking energy, and trouble sleeping.
Are there any Viekira Pak support programs?