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

Are there any other warnings one should know regarding Viekira Pak™?

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 Viekira Pak. Patients should be monitored for clinical signs and symptoms of hepatic decompensation.

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 Viekira Pak, 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.

ALT Elevations

Regardless of administration of Viekira Pak™ with or without ribavirin, in clinical trials elevations of ALT to greater than 5 times the upper limit of normal occurred in approximately 1% of all subjects. However, ALT elevations were significantly more frequent in female trial participants using ethinyl estradiol-containing medications such as combined oral contraceptives, contraceptive patches or contraceptive vaginal rings. Therefore, these types of medications must be stopped prior to starting treatment with Viekira Pak™ and alternative contraceptive methods are recommended.

Ribavirin Cautions

When Viekira Pak™ is prescribed for treatment along with ribavirin, the same warnings and precautions given regarding ribavirin should be observed, specifically avoiding pregnancy. Ribavirin may cause birth defects and/or death of the unborn baby. Pregnancy must be avoided in female patients as well as female partners of male patients. It is recommended that at least two forms of contraception be used during treatment and for at least 6 months after the completion of treatment.

Adverse Reactions or Reduced Therapeutic Effect

Concomitant use of Viekira Pak™ with certain other drugs may cause significant drug interactions leading to the loss of therapeutic effect of Viekira Pak™ as well as possible resistance to the drug. Additionally, there is the possibility of clinically significant adverse reactions from greater exposures of concomitant drugs or components of Viekira Pak™.

Risk of HIV-1 Protease Inhibitor Drug Resistance

For those co-infected with HCV/HIV-1 being treated with Viekira Pak™ should also be on a suppressive antiretroviral drug regimen to reduce the risk of HIV-1 protease inhibitor drug resistance.

Last Updated: October 2015