Get the content you want anytime you want.

FDA Adds Black Box Warning to Direct-acting Antivirals: Relevance and Guidelines for Managing the New Warning

Explaining the update, Raymond Chung, MD, co-chair of the HCV Guidance Panel, stated, “Cases of HBV reactivation (an increase of the HBV virus) during or after DAA therapy for HCV have been reported in HBV/HCV co-infected patients who were not already on HBV suppressive therapy.” Chung continued, “The severity of these cases have ranged from mild to severe fulminant liver injury that can be life threatening. While we do not know how frequently this occurs, the Guidance Panel recommends HBV testing for all patients beginning DAA treatment for HCV.”3
In addition to testing, the IDSA/AASLD recommends that healthcare professionals3:
  • Encourage HBV vaccination for susceptible individuals who have not been previously immunized or who do not have evidence of immunization
  • Test patients for HBV DNA levels before initiating direct-acting antiviral therapy in patients with a positive test result for antibodies to surface antigens of the hepatitis B virus (HBsAg)
  • Treat patients who meet testing criteria consistent with active HBV infection with HBV-specific therapy, either concurrently with, or before use of anti-HCV direct-acting antiviral therapy
  • Monitor patients with low or undetectable levels of HBV DNA periodically during anti-HCV direct-acting antiviral therapy; typically at 4-week intervals
Currently, the IDSA/AASLD does not have clear guidance on how to treat patients who have been previously exposed to HBV, and have spontaneously cleared the virus. However, it is prudent to monitor these patients for HBV reactivation. Any unexplained increase in liver enzyme levels during therapy, or after completion of HCV therapy should raise clinical suspicion.3
It is worth noting that the FDA is not the first regulatory agency to raise concerns about direct-acting antivirals. On March 17, 2016, the European Medicines Agency announced an ongoing review of direct-acting antivirals for their potential to cause reactivations of HBV infection.4
1. FDA. FDA drug safety communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C. FDA website. Published October 4, 2016. Accessed October 5, 2016.
2. Fox M. Pricey hepatitis C drugs can have deadly side-effect for some: FDA. NBC News website. Published October 4, 2016. Accessed October 5, 2016.
3. American Association for the Study of Liver Disease. People with hepatitis C should be tested for hepatitis B before starting antiviral therapies. AASLD website. Published September 16, 2016. Accessed October 5, 2016.
4. European Medicines Agency. EMA reviews direct-acting antivirals for hepatitis C. EMA website. Published April 15, 2016. Accessed October 5, 2016.
To stay informed on the latest in infectious disease news and developments, please sign up for our weekly newsletter.

Big advances in treatment can