Hepatitis B Lawsuit
Patients who have been treated with certain direct-acting antiviral (DAA) medicines for Hepatitis C may be at risk for suffering a recurrence of their Hepatitis B Virus (HBV). Recently, the U.S. Food and Drug Administration (FDA) issued its strongest warning to date, a Black Box Warning, regarding a variety of direct-acting antiviral medications used to treat Hepatitis C.
In a statement released on October 4, 2016, the FDA said, “We identified 24 cases of hepatitis B reactivation reported to FDA and from the published literature in hepatitis B/ hepatitis C co-infected patients treated with direct-acting antivirals during the 31 months from November 22, 2013 to July 18, 2016.” Of the cases reported, one patient required a liver transplant and two patients died as a result.
Chronic Hepatitis C affects more than 3.2 million Americans. In the past, it was a deadly disease that accounted for more than 15,000 deaths a year. Direct-acting antiviral medications have changed that – but at quite a price – at nearly $100,000 a treatment. When these miraculous drugs were first approved in 2014, they dramatically changed the long-term outlook for chronic Hepatitis C sufferers. These drugs finally provided a cure for the disease – unlike other drugs that could only reduce the amount of the virus in a patient’s body. In fact, DAA cure rates range upwards of 90%.
Hepatitis B Lawsuit Information and Statistics
Hepatitis B affects more than 1 million Americans and accounts for more than 3,000 deaths a year. It is currently incurable, but can go dormant for years. Unfortunately, when patients take direct-acting anti-viral medicines, it can raise the risk of HBV reoccurring, thus causing serious complications and even death. The reemergence of Hepatitis B can have deadly consequences for patients and doctors need to be aware of these complications so that they can screen all patients for evidence of current or prior HBV before starting treatment with direct-acting antivirals. This adverse event was not previously discovered in clinical trials because HBV infected patients were not included in those studies. Researchers are uncertain as to why DAA medications can trigger the emergence of HBV.
Which DAA Medications Have been Affected by FDA Black Box Warning?
To date, the following DAA medications were part of the FDA Black Box Warning:
At the moment, the FDA stopped short of recommending that all HBV infected patients stop using DAAs. They did, however, urge patients and healthcare providers to take necessary precautions. The issue of the FDA’s Black Box Warning came with an advisory for doctors and healthcare professionals to screen patients for Hepatitis B and monitor them closely before and during Hepatitis C treatment. Patients were also advised to notify their doctor if they had ever been infected with Hepatitis B prior to being treated for Hepatitis C. Lastly, all reactivation or adverse side effects from using DAAs should be reported to the FDA immediately.
Patients taking DAA medications should notify their doctor immediately if they show signs of serious liver problems such as fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes, yellow skin, and/or light-colored stools.
Hepatitis B Case Evaluations
If you suffered a recurrence of Hepatitis B as a result of taking a Hepatitis C medication, such as such as Sovaldi, Harvoni, or Viekira Pak, you may be eligible for financial compensation. To learn more about Hepatitis B Lawsuits and to discover if you or your loved one may be eligible, contact us immediately. For a free case evaluation, please complete the form on this page or call us today.