Hepatitis C Medication Lawsuit

U.S. health regulators have warned that some Hepatitis C medications like Sovaldi may cause the reactivation of the Hepatitis B virus in co-infected patients, an occurrence that could result in serious liver problems or death. Filing a Hepatitis C medication lawsuit may be an option for individuals who experienced reactivation of Hep B following use of certain direct-acting antiviral (DAA) Hep C drugs, including Harvoni, Sovadi, Technivie, Viekira Pak, and others.

Attorneys Investigating Legal Claims Involving Hepatitis C Medications

The attorneys at Bernstein Liebhard LLP are now offering free legal reviews to co-infected  Hepatitis C  and B patients who may have experienced reactivation of the Hep B virus due to their use of Sovaldi or another DAA medication. To learn more, please contact our office today by calling (888) 994-5118.

What are DAAs?

Sovaldi and other DAA medications treat – and sometimes cure- the Hepatits C virus, which affects more than 3 million Americans. The disease causes inflammation of the liver which  can lead to diminished liver function or liver failure. Most people infected with Hep C Virius  have no symptoms of the disease until liver damage becomes apparent, which may take several years.

DAAs target specific nonstructural proteins of the Hepatitis C virus, which prevents its from replicating. For example, Sovaldi is a nucleotide analogue HCV polymerase inhibitor, meaning it blocks the polymerase enzyme which Hep C must use to reproduce.

DAA Medications and Hepatitis B: What’s the Problem?

In October 2016, the U.S Food & Drug Administration (FDA) announced that a black box warning regarding the potential for Hepatitis B reactivation in co-infected patients would be added to the labels of several DAAs for Hepatitis C. DAAs subject to the label modifications 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)

The agency acted after a review of the FDA adverse event database, as well as published literature, revealed 24 cases of Hep B reactivation among co-infected patients taking DAAs to treat Hepatitis C.  All of the cases occurred during the 31 months from November 22, 2013 to July 18, 2016. Two of the reports indicated that the patients had died, while in another case the patient had to undergo a liver transplant.

“HBV reactivation was not reported as an adverse event in the clinical trials submitted for the DAA approvals because patients with HBV co-infection were excluded from the trials,” the FDA’s alert noted. “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.”

What Does the FDA Recommend?

The FDA has advised patients with a history of Hepatitis B infection or other liver problems to inform their doctor of their medical history before being treated for Hepatitis C. Current DAA patients should not stop taking their medicine without first talking to their health care professional. Patients should contact their doctor immediately if they develop signs of a serious liver problem, including:

  • Fatigue
  • Weakness
  • Loss of appetite
  • Nausea and vomiting
  • Yellow eyes or skin
  • Light-colored stools

Doctors have been advised to screen all patients for evidence of current or prior Hepatitis B infection before starting treatment with DAAs. Co-infected patients should be monitored for Hep B flare-ups or reactivation during treatment and post-treatment follow-up.

Filing a Lawsuit May Help

Co-infected patients who experience the reactivation of Hepatitis B due to Sovaldi or another DAA may incur significant damages as a result of their illness. Filing a Hepatitis C medication lawsuit could allow these patients to obtain compensation for:

  • Medical Bills
  • Lost Wages
  • Emotional Distress
  • Pain and Suffering
  • Wrongful Death (should a loved one die as a result of reactivated Hep B)

Bernstein Liebhard LLP offers free legal reviews to individuals harmed as a result of dangerous drug side effects. If you are interested in filing a Sovaldi lawsuit or other  Hepatitis C medication case following reactivation of the Hepatitis B virus, please call (888) 994-5118 to get in touch with our legal team today.

  1. FDA (2016) “FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C: http://www.fda.gov/Drugs/DrugSafety/ucm522932.htm
Last Modified: October 26, 2016

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