FDA Approves New Hep C Treatment Viekira Pak from Abbvie

The FDA approved Viekira Pak, December 19th 2014, the newest hep C treatment by AbbVie. Viekira Pak is designed to treat hep C patients who have genotype 1 varieties, with and without cirrhosis.

Viekira Pak, a double pill regimen contains three new drugs, ombitasvir, paritaprevir and dasabuvir. The double dose regimen contains one pill with the already approved ritonavir combined with paritaprevir and ombitasvir. The second pill contains dasabuvir.  Viekira Pak, an all oral treatment is interferon-free and eliminates many of the harsh side effects that come from interferon. Viekira Pak can be used however with or without ribavirin.

Viekira Pak is part of the new generation of high powered hep C treatment medications which is changing the shift of treatment bringing higher cure rates and less side effects.

The clinical studies were designed to measure when hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment.Patients achieved SVR12 (sustained virologic response), indicating the patient’s hepatitis C virus infection has been cured.

Results from multiple populations, including those considered difficult to treat, showed 91% to 100% achieved SVR 12.

 

Taken in the Morning: Two tablets of the combined ombitasvir, paritaprevir and ritonavir

Taken in Morning and Evening: One tablet of dasabuvir

Viekira Pak is to be taken with a meal without regard to fat or calorie content.

If Ribavirin is prescribed, dosing will be based on patient’s weight.

 

For VIEKIRA PAK used with ribavirin, side effects include tiredness, nausea, itching, skin reactions such as redness or rash, sleep problems, and feeling weak.

For VIEKIRA PAK used without ribavirin, side effects include nausea, itching, and sleep problems.

These are not all of the possible side effects of VIEKIRA PAK. A healthcare provider should be notified if there is any side effect that is bothersome or that does not go away.

People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.