Technivie (ombitasvir, paritaprevir, and ritonavir)
Are there any other warnings one should know regarding Technivie?
UPDATE: AbbVie discontinued Technivie effective December 31, 2018.
Hepatitic Decompensation and Hepatic Failure in Patients with Cirrhosis
As of October 22, 2015, the FDA is requiring the manufacturer to add warnings to their products after reported deaths and liver transplants in patients who already had hepatitis C related liver damage. Mostly in patients with advanced cirrhosis, hepatic decompensation and hepatic failure (including liver transplantation or fatal outcomes) have been reported when using Technivie. For patients who develop evidence of hepatic decompensation, treatment should be discontinued.
Risk of Hepatitis B Reactivation
The FDA has indicated that there is risk of the Hepatitis B virus becoming an active infection again in any patient who has a current or previous infection with Hepatitis B virus and is being treated with Technivie, a direct-acting antiviral medicine for Hepatitis C virus. In a few cases, Hepatitis B virus reactivation in patients treated with these types of medicines resulted in serious liver problems or death. In addition to a prominent warning being required on the medication’s labeling, healthcare professionals are being directed to also screen and monitor for the Hepatitis B virus in all patients receiving this treatment.
Using Technivie along with certain other drugs may result in known or potentially significant drug interactions which, in some cases, could lead to loss of effectiveness of Technivie.
Using Technivie with some drugs can alter plasma concentrations of some medications and some medications may alter the plasma concentrations of Technivie.
Last Updated: December 2018
Bristol-Myers wins approval for 1st hepatitis C type 3 drug. http://www.washingtontimes.com/news/2015/jul/24/bristol-myers-wins-approval-for-1st-hepatitis-c-ty/, The Washington Times. Retrieved July 28, 2015.
Highlights of Prescribing Information - TECHNIVIE. http://rxabbvie.com/pdf/technivie_pi.pdf, AbbVie, Inc. Retrieved July 28, 2015.