The U.S. Food and Drug Administration (FDA) has mandated that its most serious warning, the so-called “black box,” be placed on nine brand name hepatitis C virus (HCV) drugs.
The call for the black box followed 24 reported cases of reactivation of HPV in patients who were being treated with direct acting antiviral (DAA) medications to treat their HCV, according to Yahoo.
The FDA explained that, “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 agency pointed out that, with no treatment, “HCV can lead to serious liver problems including cirrhosis, liver cancer, and death.”
The DAA medications were tested on patients who were diagnosed with only HCV during the clinical trials, Yahoo reported. The trials did not include those individuals who were infected with both HBV and HCV because the agency sought to look at the potential for developing side effects in those patients who were only diagnosed with HCV. This means that the potential for treatment with a DAA drug on HCV patients who were diagnosed with HBV as well and for the likelihood of the HBV reactivating was not thought of.
HBV reactivation is significant as it may lead to serious liver injury such as the need for liver transplant and even 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 agency announced. “Of the cases reported, two patients died and one required a liver transplant,” the agency added.
The black-box warning involves Sovaldi and Harvoni manufactured by Gilead Sciences Inc., Viekira Pak manufactured by AbbVie Inc., and Zepatier manufactured by Merck & Co. The number of HCV/HBV co-infected individuals treated with these drugs is not known. The following is a more complete list of DAA drugs:
- 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 Abbvie
- Xepatier: Manufactured by Merck Sharp Dohme
In October 2015, the FDA issued a warning on the Viekira Pak and Technivie DAA drugs over potential ties to serious liver injury or death in people with underlying advanced liver disease. In March 2016, the European Medicines Agency (EMA) began reviewing the issue and, soon after, Japan’s Pharmaceuticals and Medical Devices Agency began conducting its own review.
