According to data from the Centers for Disease Control and Prevention (CDC), hepatitis C infections affect approximately four million people in the United States and approximately 170 million people globally. Acute infections can develop into chronic infections that have the potential to cause serious and potentially fatal liver damage.
Treatments, some of which are considered cures for hepatitis C exist, but there is currently no approved hep C vaccine on the market. Several things stand in the way of an effective vaccine, including the multiple genotypes of hepatitis C, the ability for hepatitis C to mutate easily, and the lack of small animal models available for testing.
Vaccine studies are underway, though, and one promising study will be ending in 2016. However, at the moment, the best options for treating hepatitis C infections are to use DAAs, which is short for direct-acting antivirals. These medications are considered extremely effective, but recent evidence has shown they are not right for everyone and in some cases, use of DAAs can be extremely risky.
Potential for Hep C Medications to Reactive Hepatitis B Virus and Cause Serious Liver Damage
Concern for the safety of hepatitis C medications is serious enough that the US Food and Drug Administration (FDA) recently issued its strongest warning concerning many of the most commonly used and successful hep C treatments, including Sovaldi, Harvoni, and Viekira Pak.
The warning came in early October 2016, after the agency determined there to be a significant risk for those with previous hepatitis B exposure to develop reactivation of that virus when using DAAs to treat hepatitis C.
In addition to the reactivation of hepatitis B, there is also evidence the reactivation can cause serious, potentially fatal, liver damage.
In response to the discovery, the FDA utilized its strongest warning system, the Boxed Warning, which requires drug manufacturers to place a warning label on all of its products related to the issue. In addition to the Boxed Warnings, the FDA is also encouraging medical practitioners to screen patients for hepatitis B and monitor them for symptoms of the virus while undergoing hepatitis C treatment with DAAs.
Link between DAAs and Hepatitis B Recurrence Not Previously Known
The agency has been looking at the potential for hepatitis C treatments to reactivate hepatitis B virus cases for approximately two years, but admits the issue was not discovered until after approval of the DAAs on the market. The medications were tested in clinical trials, but those studies did not include any patients that had previously received a diagnosis of hepatitis B. Estimates show approximately 850,000 to two million people in the United States are affected by hepatitis B infections.
According to information from the FDA, so far, only 24 cases of reactivated hepatitis B viruses have been identified from November 2013 to July 2016 in those undergoing treatment for hep C. However, the agency warns this is likely just a small sample of those actually affected and it believes the number of people affected is likely far more significant.
If you or a loved one was diagnosed with hepatitis C and prescribed DAAs or any other type of hep C vaccine or medication, and you believe the use of that treatment resulted in a recurrence of a previous hepatitis B infection, you might be eligible to take legal action. Contact us to learn more or to discuss the details of your case.
Additional Resource: https://www.drugdangers.com/hepatitis-c/lawsuit/