Vosevi (sofosbuvir, velpatasvir and voxilaprevir)
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Are there any other warnings one should know regarding Vosevi?
Bradycardia When Coadministered with Sofosbuvir and Amiodarone
The FDA has warned that a serious slowing of the heart rate can occur when using amiodarone along with sofosbuvir, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Taking of amiodarone with Vosevi is not recommended. In patients without alternative viable treatment options, cardiac monitoring is recommended.
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 Vosevi, 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 2017
"FDA approves Vosevi for Hepatitis C" FDA.gov. U.S. Food & Drug Administration. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm567467.htm. Retrieved October 6, 2017.
"Highlights of Prescribing Information." Gilead.com. Gilead Sciences Inc., http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/vosevi/vosevi_pi.pdf. Retrieved October 6, 2017.
"Vosevi is FDA approved." Vosevi.com. Gilead Sciences Inc., http://www.vosevi.com/. Retrieved October 6, 2017.
