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%.
Can Hepatitis C medication cause a flare up of Hepatitis B?
Managing a hepatitis infection is stressful enough without worry for your medication causing a reaction. Unfortunately for those taking a certain type of medication for Hepatitis C, there is cause for concern their treatment might backfire.
Some people taking certain direct-acting antiviral (DAA) drugs for Hepatitis C could be at risk for a recurrence of Hepatitis B.
As of 2016, the FDA now requires DAA drugs to feature a black box warning, the agency’s most severe alert, concerning the risk for re-activation of Hepatitis B infections. The requirement came after the agency received 24 cases of Hepatitis B reported after use of DAAs between 2013 and 2016.
Of the reported cases, one DAA user required a liver transplant and two died.
Treating Hep C
Hepatitis C is a deadly disease affecting more than three million Americans. DAA drugs have had a significant impact on the lives of those with this disease. They were approved by the FDA in 2014 and have changed the long-term prognosis for those with Hepatitis C with a cure rate of as much as 90 percent.
Unfortunately, the news hasn’t all been good and many using DAAs soon learned of at least one devastating side effect from DAAs.
The following DAA medications have been linked to reactivation of Hepatitis B viruses:
- Harvoni
- Daklinza
- Epclusa
- Olysio
- Sovaldi
- Technivie
- Viekira Pak
- Viekira Pak XR
- Zepatier
Hepatitis B has no cure, but the virus can be dormant for years at a time. The reactivation of this disease through the use of DAAs can be deadly.
The link between DAA use and Hepatitis B was not discovered during the testing phase because people with HBV were not included in clinical trials for DAAs.
In many cases, had patients known there was a link between using treatment for Hepatitis C and reactivating their HBV infection, they might have chosen different treatment. They made their decisions based on incomplete and/or inaccurate information.
FDA Encourages HBV Screening for DAA users
As a result of the link between DAAs and Hepatitis B reactivation, doctors are encouraged to screen for HBV prior to prescribing DAA medication to patients as part of the black box warning.
The FDA has not yet recommended that those infected with HBV stop using DAAs, but they are urging doctors to use caution. If you have any strange symptoms after using DAAs, whether they could be linked to HBV or whether you’ve been diagnosed with that disease, you should speak to your doctor.
Users of DAA should be on alert for side effects such as:
- Fatigue
- Loss of appetite
- Nausea and/or vomiting
- Yellow eyes and skin
- Light colored stool
These symptoms could be a sign of a serious liver problem and could be linked to reactivation of an existing HBV infection.
Hepatitis B Lawsuits
If you or a loved was prescribed a DAA drug without being screened for HBV and use of the medication triggered a recurrence of Hepatitis B, you might be eligible for compensation.
Have you used Harvoni, Sovaldi, or Viekira Pak and suffered a flare up of HBV? You should contact an attorney as soon as possible.
Hepatitis B lawsuits are being filed throughout the country by DAA users. Patients and those who have lost loved ones are taking action against the makers of these drugs. It’s important you contact an attorney as soon as possible, as there might be a statute of limitations that affects how long you have to act.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.