Viekira Pak is a medication used to treat patients with hepatitis C. It was approved by the FDA in 2014 and given to patients with genotype 1 chronic hepatitis C virus with compensated cirrhosis (liver damage).
Though considered effective, the FDA issued a warning in 2015 concerning Viekira Pak and its likelihood to cause significant liver damage, especially in patients who already suffer from advanced liver conditions. The drug was previously known to trigger a variety of other medical issues, including thinning blood, lack of appetite, and anemia, but the 2015 warning was especially concerning because the liver complications could lead to death.
Link Discovered between Hepatitis B and Viekira Pak
Now, there is additional concern Viekira Pak and other medications similar to it and used to treat hepatitis C infections could trigger a reactivation of hepatitis B in patients with previous exposure to that virus.
The most recent warning from the FDA, and the strongest the agency issues, came at the beginning of October 2016 and alerted Viekira Pak users and doctors prescribing the mediation to patients of the risk associated with hepatitis B infections. There is also evidence patients treated with Viekira Pak have also experienced further liver complications associated with the hepatitis B reactivation.
Viekira Pak and many of the hepatitis C medications available on the market today have received a great deal of positive attention. They earn a great deal of money for their manufacturers and are considered relatively safe for many users. However, when these medications were tested for safety, they were not given to any test subjects with previous exposure to hepatitis B.
The ability of these drugs to reactive a hepatitis B infection was not discovered until the medications were approved and the general public – many of whom had hepatitis B infections – began using them. According to FDA data, there had only been 24 cases of hepatitis B reactivation published in medical literature between 2013 and 2016, but the agency assumes that is just a small fraction of the group that has likely been affected.
FDA Issues Boxed Warning
In addition to requiring the Boxed Warning for Viekira Pak and other hepatitis C medications, the FDA is also alerted doctors and encouraging them to screen and monitor patients undergoing hepatitis C treatment for hepatitis B signs or symptoms. There are an estimated 2.7 to 3.9 million people in the United States infected with hepatitis C and approximately 850,000 to just over two million affected by hepatitis B.
If you or a loved one are taking Viekira Pak for hepatitis C infection and you experience any issues that could be linked to liver health, including fatigue, weakness, nausea or vomiting, loss of appetite, yellow discoloration of the skin or eyes, or light colored stools, or you have been affected by hepatitis B, it’s important you contact your doctor to discuss your risk. You might also be eligible for financial compensation if it can be shown your reactivated hepatitis B infection and/or liver damage is linked to your use of Viekira Pak or any other hepatitis C drug.