Cases of Reactivation of Hepatitis B Virus (HPV) in Patients. Following 24 reported cases of reactivation of hepatitis B virus (HPV) in patients taking direct acting antiviral (DAA) medications to treat hepatitis C virus (HCV), the U.S. Food and Drug Administration (FDA) has mandated a “black-box warning,” the agency’s most serious label, on nine brand name drugs for HCV.
According to the FDA, “Direct-acting antiviral medicines are used to treat chronic hepatitis C virus (HCV) infection, an infection that can last a lifetime. These medicines reduce the amount of HCV in the body by preventing HCV from multiplying, and in most cases, they cure HCV.” The federal regulator noted that, without treatment, “HCV can lead to serious liver problems including cirrhosis, liver cancer, and death.”
This adverse event is significant and may lead to serious liver injury, including liver transplant and death. “We identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs during the 31 months from November 22, 2013 to July 18th. This number includes only cases submitted to FDA, so there are likely additional cases about which we are unaware,” the FDA announced. “Of the cases reported, two patients died and one required a liver transplant,” according to the FDA.
DAA drugs were tested on patients diagnosed with HCV only during clinical trials, according to Yahoo. The clinical trials excluded individuals who were also infected with HBV as the federal regulator was seeking to review the likelihood of developing side effects in patients who were only infected with HCV. The opportunity for DAA treatment on HCV patients who were also diagnosed with HBV and for the HBV to reactivate was not considered.
DAA Treatment on HCV Patients Who Diagnosed with HBV
The black-box warning involves Sovaldi and Harvoni from Gilead Sciences Inc., Viekira Pak from AbbVie Inc., and Zepatier from Merck & Co. The following is a more complete list of Direct-Acting Antivirals:
- Daklinza: Manufactured by Bristol-Myers Squibb
- Epclusa: Manufactured by Gilead Sciences
- Harvoni: Manufactured by Gilead Sciences
- Olysio: Manufactured by Janssen
- Sovaldi: Manufactured by Gilead Sciences
- Technivie: Manufactured by Abbvie
- Viekira Pak: Manufactured by Abbvie
- Viekira Pak XR: Manufactured by Abbie
- Xepatier: Manufactured by Merck Sharp Dohme
It remains unknown how many HCV/HBV co-infected individuals were treated with these drugs.
Meanwhile, in October 2015, the FDA issued a warning on the Viekira Pak and Technivie over their potential association with serious liver injury or death in individuals with underlying advanced liver disease. In March 2015, the European Medicines Agency announced that it was reviewing the matter and Japan’s Pharmaceuticals and Medical Devices Agency followed up with its own review.