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Sovaldi and other Hepatitis C medications known as direct-acting antivirals (DAA) have revolutionized the treatment of Hep C, promising shorter treatment times, higher cure rates, and fewer side effects. However, the U.S. Food & Drug Administration (FDA) recently warned that some of these Hep C medications may also reactivate a current or previous Hepatitis B virus. In a few cases, Hep B reactivation in patients treated with DAA medicines resulted in serious liver problems or death.

What are DAA Hepatitis C Medications?

According to the U.S. Centers for Disease Control (CDC), an estimated 2.7 to 3.9 million people in the U.S. are infected with chronic Hepatitis C. DAA medicines prevent the virus from multiplying, and in most cases, they cure the disease. Without treatment, the Hepatitis C can lead to serious liver problems including cirrhosis, liver cancer, and death.

DAA’s currently approved for use in the U.S. include:

• Daklinza (daclatasvir)
• Epclusa (sofosbuvir and velpatasvir)
• Harvoni (ledipasvir and sofosbuvir)
• Olysio (simeprevir)
• Sovaldi (sofosbuvir)
• Technivie (ombitasvir and paritaprevir and ritonavir)
• Viekira Pak (dasabuvir and ombitasvir and paritaprevir and ritonavir)
• Viekira Pak XR (dasabuvir and ombitasvir and paritaprevir and ritonavir)
• Zepatier (elbasvir and grazoprevir)

DAA medications are extremely expensive. For example, Sovaldi costs $1,000 a day for all 12 weeks of treatment. Of course, this means big profits for drug companies. In its first year on the market, Sovaldi racked up over $10 billion in sales.

DAAs target specific nonstructural proteins of the Hepatitis C virus, resulting in disruption of viral replication and infection. For example, Sovaldi is a nucleotide analogue HCV polymerase inhibitor, meaning it blocks the polymerase enzyme which the virus must use to reproduce.

FDA Warning for DAAs and Hepatitis B Reactivation

In October 2016, the FDA announced that it had identified 24 cases of Hepatitis B reactivation reported to its database and in the published literature. All of the cases had occurred in the 31 months from November 22, 2013 to July 18, 2016 in patients co-infected with Hep B and Hep C. Two patients died and one required a liver transplant. Because not all adverse events are reported to the FDA, the agency acknowledged that there are likely to be additional unreported cases of Hepatitis B reactivation among patients treated with DAA Hepatitis C medications.

Reactivation of Hepatitis B virus was not reported in clinical trials for DAA medications, as individuals with Hep B co-infection were excluded from the studies. “The trials excluded these patients in order to specifically evaluate the safety of DAAs, including their effects on the liver, in patients infected with only HCV and without the presence of another virus which affects the liver,” the FDA said.

The FDA is now requiring a Boxed Warning, its most prominent safety notice, regarding the risk of Hepatitis B virus reactivation to be added to the drug labels of certain DAAs. All nine Hepatitis C medications in the DAA class subject to the label update including Sovaldi, Harvoni, Technivie and Viekira PAK.

In December 2016, a warning was issued in Europe regarding the potential for direct-acting antiviral Hepatitis C medications to reactivate a latent Hepatitis B virus. According to December 2^nd communication issued by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), at least 30 cases of Hepatitis B reactivation have been reported in Europe among patients treated with these drugs. Read More

What Should Doctors and Patients Do?

The FDA is directing healthcare professionals to screen and monitor for Hepatitis B in patients receiving Sovaldi or another DAA treatment. The agency has advised DAA patients co-infected with Hep C and Hep B to contact their doctor immediately if they develop any of the following symptoms, which could be signs of a serious liver problem:

• Fatigue
• Weakness
• Loss of appetite
• Nausea and vomiting
• Yellow eyes or skin

Patients should not stop taking their DAA medicine without first talking to their health care professional, as doing so could result in the virus becoming less responsive to certain Hepatitis C medicines.

DAAs and Liver Injuries

In January 2017, an analysis of the  FDA’s adverse event database conducted by the  Institute for Safe Medicine Practices reported that DAAs had been cited in more than 500 reports of liver failure during the fiscal  year ending June 30, 2016. More than 1,000 liver injury reports were also associated with the Hepatitis C medication. The incidents were a separate issue from liver problems related to Hepatitis B reactivation.

The adverse event reports are not definitive proof of a causal connection between DAAs and liver injuries. The reports in the FDA database were provided by healthcare professionals who merely suspected that direct-acting antivirals might be the cause of patient injuries.  Read More