FDA Warns That Hep C Meds Can Reactivate Hep B

Law360, New York (October 4, 2016, 6:55 PM EDT) -- The U.S. Food and Drug Administration on Tuesday said it's requiring boxed warnings on hepatitis C medications called direct-acting antivirals, including Gilead Sciences Inc.'s Harvoni and Sovaldi and AbbVie Inc.'s Viekira Pak, warning that the medication can reactivate hepatitis B in patients who have previously had it.

Between Nov. 22, 2013, and July 18, 2016, there have been 24 cases reported to the FDA of hepatitis B reactivation in patients who were being treated with DAAs, leading to two deaths and one liver transplant, the agency said. The FDA said it doesn't know what's causing the negative reaction, and urged physicians to...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.


  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!

TRY LAW360 FREE FOR SEVEN DAYS

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!