Harvoni lawsuits may soon begin to emerge after the FDA issued a Black Box Warning for the popular and expensive direct acting antiviral (DAA) medication. Harvoni, usually prescribed to treat Hepatitis C, is one of 9 DAA medications that the FDA believes could trigger a reactivation of the Hepatitis B virus (HBV) in some patients. As a result, the FDA issued their strictest warning possible on October 4, 2016. They also urged physicians to begin screening patients for HBV prior to beginning Harvoni treatment for Hepatitis C. Patients who have taken Harvoni to treat Hepatitis C, but who have seen a reactivation of their Hepatitis B and subsequently experienced liver damage or liver failure, should contact an experienced Harvoni lawsuit attorney immediately to review their case.
What is Harvoni?
Harvoni is a new prescription medication that is used to treat chronic Hepatitis C virus (HCV). In 2014, drugs like Harvoni were approved by the FDA for treating Hepatitis C. This drug was quickly embraced by the medical community because of its amazing success rate. Unlike previous HCV drugs, Harvoni and other DAA medications provide a cure for the disease by stopping the replication of the virus in the patient’s body. In fact, there is a 90% cure rate with little to no side effects. Until now.
Now, Harvoni is one of 9 medications that the FDA believes could trigger the reactivation of HBV in patients, leading to sudden liver failure and even death. The FDA identified 24 patients who experienced a reemergence of their HBV after taking DAA medications to treat chronic Hepatitis C. Of those patients 2 died from the reactivation of their HBV and one required a liver transplant. When Harvoni and other DAA medications were undergoing clinical trials, they were not tested on patients who had multiple infections, such as HBV. As a result, researchers were unaware of Gilead’s propensity to trigger reactivation of such viruses.
Gilead Faces Scrutiny for Profiting Greatly from Harvoni
The manufacturer raked in profits during the last several years for their pricey medication. It is estimated that a full course of Harvoni is priced at $94,500 – making it difficult for many patients to afford this life-saving treatment. The price was so exorbitant that the Massachusetts attorney general threatened to sue Gilead for unfair trade practices. In December, a Senate committee thrashed the pharmaceutical giant for putting profits before patients when it set the drug prices.
Yet despite the bad publicity and scrutiny, it generated $12 billion in US sales since the end of 2014. It’s sister drug, Sovaldi, generated $11 billion in the same time frame.
What is Hepatitis C & Hepatitis B?
Hepatitis B & C are liver diseases caused by 2 different viruses. Hepatitis C is a contagious liver disease that usually is contracted through exposure to contaminated blood, like through transfusions, needle sticks, or drug usage. It is estimated that at least 3.5 million Americans have Hepatitis C viral infections, which usually lies dormant for years, before causing liver failure. Approximately 19,000 people die each year from Hepatitis C related liver disease. With these newer DAA drugs, Hepatitis C can effectively be cured in up to 90% of all patients.
Hepatitis B, on the other hand, cannot be cured. Once it is contracted, the virus remains in the person’s body – often dormant – for years. Chronically infected people can spread the virus to others, even when they do not look or feel sick themselves. Up to 1.4 million Americans in the United States has chronic Hepatitis B virus infections. HBV is spread through direct contact with contaminated blood, semen, or other body fluids. Currently there is a Hepatitis B vaccine that can prevent it and its consequences – but once contracted, there is no cure. About 2,000 people in the U.S. die from HBV related liver disease.
If you suffered a recurrence of Hepatitis B as a result of taking a Hepatitis C medication, such as such as Sovaldi, Harvoni, or Viekira Pak, you may be eligible for financial compensation. To learn more about Harvoni Lawsuits and to discover if you or your loved one may be eligible, contact us immediately. For a free case evaluation, please complete the form on this page or call us today.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.