Are there any other warnings one should know regarding Zepatier? | Hepatitis Central

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Zepatier (elbasvir and grazoprevir)

Are there any other warnings one should know regarding Zepatier?

ALT Elevations

During clinical trials elevations of ALT from normal to greater than 5 times the upper limit of normal occurred in approximately 1% of subjects. ALT elevations were typically asymptomatic, occurred generally at week 8 of treatment and resolved with ongoing or completion of treatment.

Drug Interactions

Using Zepatier along with certain other drugs may result in known or potentially significant drug interactions which, in some cases, could lead to clinically significant adverse reactions and/or significant decrease of elbasvir and grazoprevir plasma concentrations which can lead to loss of effectiveness of Zepatier as well as the possibility of Zepatier drug resistance.

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 Zepatier, 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.

Last Updated: October 2016

"Highlights of Prescribing Information." Merck.com. Merck Sharp & Dohme Corp., http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf. Retrieved February 1, 2016.

"Patient Information: Zepatier™." Merck.com. Merck Sharp & Dohme Corp., http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_ppi.pdf. Retrieved February 1, 2016.

"Zepatier Multiuse Savings Coupon." Activatethecard.com. Merck Sharp & Dohme Corp., https://www.activatethecard.com/7208/#. Retrieved February 1, 2016.

"Zepatier (Elbasvir and Grazoprevir) Official Website." Zepatier.com. Merck Sharp & Dohme Corp., https://www.zepatier.com/. Retrieved February 1, 2016.