Viekira Pak

Viekira Pak is an oral, direct-acting antiviral medication used to treat Hepatitis C. Viekira Pak is marketed by Abbvie, Inc., and was approved by the U.S Food & Drug Administration (FDA) in December 2014.

What is Viekira Pak?

Viekira Pak contains three direct-acting antivirals (paritaprevir/ritonavir/ ombitasvir and dasabuvir) that prevent the replication of the Hepatitis C virus. It is approved to treat adults with Hepatitis C genotype 1. Viekira Pak is taken twice daily, with food, for 12 or 24 weeks. Sometimes Viekira Pak is taken in conjunction with ribavirin.

Approximately 3.2 million Americans are infected with Hepatitis C.  Most people who contract the virus will not experience symptoms until their liver damage becomes apparent.  If not properly treated, 15% to 30% of those infected with the Hepatitis C virus will go on to develop cirrhosis.

Viekira Pak and other direct-acting antivirals can cure Hepatitis C.  Adherence – ensuring that no doses are missed – is the most important thing  a Viekira Pak  patient can do to achieve a cure. Adherence will also lower the risk that the Hepatitis C virus will become resistant to treatment.

Viekira Pak Side Effects

Common side effects of Viekira Pak include fatigue, nausea, itching, skin reactions, insomnia, and weakness. Patients using Viekira Pak should contact their doctor if they experience:

  • Abdominal or stomach pain
  • Bloating of the abdomen or stomach
  • Dark urine
  • Light-colored stools
  • Nausea and vomiting
  • Yellow eyes or skin
  • Blistering, peeling, or loosening of the skin
  • Chills
  • Cough
  • Diarrhea
  • Itching
  • Joint or muscle pain
  • Red skin lesions, often with a purple center
  • Red, irritated eyes
  • Sore throat
  • Sores, ulcers, or white spots in the mouth or on the lips
  • Unusual tiredness or weakness

 Viekira Pak Liver Injuries

In October 2015, the FDA warned of serious liver injuries connected with the use of Technivie and Viekira Pak, most of which had occurred in individuals with underlying advanced liver disease. Patients taking these drugs should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury.

In January 2017, the Institute for Safe Medicine Practices reported that paritaprevir combination drugs, including Viekira Pak, were the primary suspect in 120 liver injury cases reported to the FDA’s adverse event database as of the fiscal year ending June 30, 2016. The drugs were suspected as a secondary cause in 61 cases.

Hepatitis B Reactivation

In October, the FDA  ordered the manufacturers Viekira Pak, Technivie and other direct-acting antivirals   to include a Black Box Warning on their labels regarding the risk of Hepatitis B reactivation in co-infected patients. At the time, the agency said that 24 such cases had been reported in relation to direct-acting antivirals during the 31-month period running from November 22, 2013 to July 18, 2016. Two patients died and one required a liver transplant. Co-infected patients taking these drugs should contact their doctor immediately if they experience Hepatitis B symptoms, including fatigue, weakness, loss of appetite, nausea and vomiting, and yellow eyes or skin.

  1. FDA (2014) “FDA approves Viekira Pak to treat hepatitis C”
  2. FDA (2014) “Highlights of Prescribing Information”
  3. FDA (2015) “FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie”
  4. ISMP (2017) “QuarterWatch”
  5. FDA (2016) “FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C:
Last Modified: January 30, 2017

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