FDA Requires Black Box Warning for Hepatitis C Drugs


Just a few years ago, there was no cure for hepatitis C. Patients had to live with the disease for life and potentially develop serious liver diseases such as cirrhosis and cancer. It even led to death.
Now, there are several options for those tired of living with the disease and want to cure it for good. Harvoni, Sovaldi, Daklinza and Viekra Pak are popular medications used for this purpose – but could they be too good to be true?

Adverse Events Reported

Six months ago, it was determined that these drugs – and several others – may cause the hepatitis B virus to reactivate. In addition, some patients have experienced the return of liver cancer and other serious conditions. These drugs have even led to a liver transplant in one case and death in two instances.

The Food and Drug Administration (FDA) has taken note of these adverse events and is now requiring a Boxed Warning, the most serious warning. Direct-acting antivirals used for hepatitis C treatment must have this warning on the box as well as the medication guides and patient information leaflets.

Types of Medications Used to Cure Hepatitis C

Direct-acting antivirals are prescription medications that are FDA-approved for adults with hepatitis C. They can be used alone or with other medications. The nine medications available in the United States are the following:

• Harvoni (manufactured by Gilead Sciences)
• Epclusa (manufactured by Gilead Sciences)
• Solvadi (manufactured by Gilead Sciences)
• Daklinza (manufactured by Bristol-Myers Squibb)
• Zepatier (manufactured by Merck Sharp Dohme)
• Olysio (manufactured by Janssen)
• Technivie (manufactured by Abbvie)
• Viekira Pak (manufactured by Abbvie)
• Viekira Pak XR (manufactured by Abbvie)

Drug Safety Communication Released

On October 4, 2016, the FDA released a Drug Safety Communication warning health care providers about the adverse events that have been reported between November 22, 2013 and July 18, 2016. During that time period, the FDA identified 24 cases of hepatitis B reactivation. Of these, one patient needed a liver transplant and two patients died. In the clinical trials, hepatitis B reactivation was not considered an adverse event because patients who had hepatitis B were not included in those trials. It is possible that there were many more adverse events that were not reported to the FDA.

What the FDA Knows About the Hepatitis B Reactivation

• While undergoing treatment for hepatitis C, many patients have seen the hepatitis B virus recur. Some cases have led to liver failure and even death. It is not known how the reactivation occurs.

• Hepatitis B reactivation is defined as a rapid increase in serum HBV DNA level. Patients will have hepatitis B surface antigen even though they previously tested negative for this antigen. They will experience an increase in bilirubin and transaminase levels, which can eventually lead to liver failure and death.

• Patients with were anti-hepatitis B core antibody positive and hepatitis B surface antigen negative have developed a hepatitis B reactivation.
What Patients Should Do
Communication is key. Let your doctor know if you have experienced hepatitis B or other liver problems in the past. Continue taking medications as directed unless your doctor tells you otherwise. Read the Medication Guide or patient leaflet information fully. Contact your doctor if you experience any signs of liver disease, which include the following:
• Nausea/vomiting
• Yellowing of the skin or eyes
• Weakness
• Fatigue
• Loss of appetite

What Health Care Providers Should Do

Many patients may not know if they have hepatitis B. Therefore, health care professional should screen all patients for hepatitis B before starting any medication. Continue to monitor patients for hepatitis B reactivation during and after treatment. Report any adverse events to the FDA.


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