Sovaldi Lawsuit

Sovaldi is a medication meant to treat hepatitis C. However, evidence surfaced that Sovaldi could cause a reemergence of hepatitis B in patients. Due to these negative effects of the drug, patients are filing lawsuits against the parent company Gilead Sciences for failing to adequately warn patients of the long-term effects, as well as the high cost of the drug. The FDA has issued a black box warning, however, patients continue to face the consequences of Sovaldi use in healthcare practices today.

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What Sovaldi Lawsuits Are There?

Hepatitis C patients across the U.S. have filed lawsuits regarding the pricey Sovaldi medication. While the drug has made sales in markets across the world, the U.S. pharmaceutical market has made over 40 billion dollars in revenue from drug sales of people dealing with chronic hepatitis C. The class action lawsuit claims have stated that the prices for the medication exceed any lawful drug pricing for similar medications on the market. Some state Medicaid programs have even raised flags against the drug Sovaldi, but the pharmaceutical giants have made claims that Sovaldi treatment can prevent patients from needing liver transplant surgery. The University of Minnesota launched a lawsuit against the drug in 2016 for patent infringement, and there are also impending lawsuits against Sovaldi and Walgreens in the U.S. Circuit Court of Appeals for evading liability.

Why Did People File Sovaldi Lawsuits?

People continue to file lawsuits for the Sovaldi drug because of its adverse side effects and because of the exorbitant cost of treatment under the drug. Due to the high cost, as of 2022, some organizers are working with prison systems to drastically drop the price of the drug after years of scrutiny to help those suffering from hepatitis C.

What Sovaldi Lawsuit Settlements Are There?

Thousands of hepatitis C patients have filed lawsuits against Gilead for the sky-high prices of the Sovaldi, working to expand Medicaid coverage in their state. In 2018, however, Sovaldi’s manufacturing company Gilead Sciences won a reversal settlement of 2.5 billion dollars. As of 2021, two Florida class-action lawsuits came to a settlement coverage of hepatitis C drugs.

There are still pending lawsuits under the U.S. court of law yet to come to a settlement.

What Is Sovaldi?

Sovaldi, or sofasbuvir, is a prescription medication that is used to treat chronic hepatitis C. The drug was approved by the FDA in 2013, and unlike older hepatitis C medications, Sovaldi provides an essential cure for the deadly disease by preventing HCV from multiplying in a patient’s body. It is often used in combination with other antiviral medications and together they can have a 90% cure rate.

Is Sovaldi Available Over the Counter?

Sovaldi is not available over the counter. It is typically given to patients orally and requires a prescription and order from a doctor.

Who Manufactures Sovaldi?

Sovaldi is made by the American pharmaceutical giant, Gilead Sciences, and the company has raked in profits from this medication in recent years. Gilead Sciences has a presence across six continents, and in addition to manufacturing Sovaldi, Gilead Sciences also develops drugs to treat:

  • HIV/Aids
  • COVID-19
  • Influenza

The company Gilead Sciences also has an initiative to become one of the top ten oncology organizations by 2030.

How Much Does Sovaldi Medication Cost?

Unfortunately, this medication is pricey – costing $1,000 a day for all 12 weeks of treatment. Due to the exorbitant cost, however, most state Medicaid programs cannot afford it and, therefore, must sharply limit access to only the sickest patients. As of 2022, some patients have to pay $84,000 worth of medication for treatment.

How Does Sovaldi Work?

Sovaldi blocks the RNA-dependent protein within the hepatitis virus, halting the spread of infection. Used as an antiviral agent, the drug stops replication of the virus enzymes and can terminate signs of disease in hepatitis C patients.

What Does Sovaldi Treat?

Sovaldi was developed primarily to treat hepatitis C, usually in patients who have chronic hepatitis C. Without treatment, hepatitis C cannot be cured and if left untreated will attack the liver, leading to liver failure.

What Is Hepatitis C?

Hepatitis C is a contagious liver disease that is transmittable through direct contact with contaminated blood, such as through a blood transfusion, infected needles, needle sticks in the healthcare setting, or a baby born to a mother with hepatitis C. The viral infection can cause liver damage and excess inflammation.

What usually starts as acute hepatitis C virus, however, quickly turns into chronic hepatitis C infections in up to 85% of patients. It is estimated by the CDC that up to 3.9 million people in the United States suffer from chronic hepatitis C. 

If left untreated, hepatitis C can turn deadly, causing liver failure.

What Are the Symptoms of Hepatitis C?

The most common symptoms of hepatitis C include:

  • Swelling of the legs
  • Bruising easily
  • Fatigue
  • Weight loss
  • Slurred speech
  • Dark-colored urine

What Are the Side Effects of Sovaldi?

The most common side effects of taking Sovaldi are:

  • Headache
  • Insomnia 
  • Fatigue
  • Nausea

What Are the Serious Side Effects of Sovaldi?

Some more serious side effects can occur when taking Sovaldi for hepatitis C. Anyone experiencing any of these symptoms should contact a medical professional.

What Is Anemia?

Anemia occurs when there are not enough red blood cells to carry oxygen to the lungs. Without adequate support to the rest of the body’s tissues, the body may not be able to support high levels of activity and will become fatigued. Anemia could be short-term due to a lack of important nutrients such as iron, or it could become chronic after taking certain medications.

What Are the Symptoms of Anemia?

The symptoms of anemia are typically tiredness, headaches, dizziness, weakness, or shortness of breath. If any of these symptoms persist, always talk to a doctor immediately as consistently low hemoglobin can be unsafe.

What Is Reactivation of Hepatitis B?

When a reactivation of Hepatitis B occurs, it can sometimes be delayed. Due to this delay, the symptoms may be confused with other illnesses. If a patient has been exposed to Hepatitis earlier in life, there is a risk that it could resurface when an individual becomes immunocompromised. Other risk factors of reactivation include the volume of the viral load and the age of a patient.

What Are the Symptoms of a Reactivation of Hepatitis B?

The signs of a reactivation of hepatitis B are jaundice, abdominal pain, fatigue, body aches, or vomiting. These signs could also be indicative of other illnesses, however, if you have had hepatitis before it could be a sign that the virus has returned.

What Is an Allergic Reaction?

Allergies, or allergic reactions, occur as a response to a foreign substance coming in contact with the body. Allergic reactions can occur because of food, environmental irritants like pollen, or they can occur because of a pharmaceutical drug. While some allergies can be mild, severe allergic reactions will require hospitalization.

What Are the Symptoms of an Allergic Reaction?

The most frequent symptoms associated with a severe allergic reaction are watery eyes, sneezing, itching, hives, or trouble breathing. If you suspect you are allergic to Sovaldi ask your healthcare provider if there are different treatment options.

What Warnings Has the FDA Issued for Sovaldi?

Patients who have previously been diagnosed with hepatitis B are at an increased risk of seeing a reactivation of their HBV while undergoing Sovaldi treatment for hepatitis C. The FDA warns that reactivation usually occurs within 4-8 weeks of treatment. They identified 24 cases of HBV reactivation within 31 months. During this time, 2 of those patients died and one required a liver transplant. At the moment, researchers are uncertain as to why Sovaldi would trigger a reactivation of HBV.

The FDA is urging physicians and healthcare providers to screen all patients for HBV before starting their treatment. Any patient with a history of HBV should be monitored closely for signs and symptoms of flare-ups or reactivation during treatment and post-treatment follow-up.  Symptoms of reactivation include vomiting, nausea, yellow skin and eyes, light-colored stools, and fatigue.

Sovaldi isn’t the only DAA that received the FDA’s strict Black Box Warning. Many therapies from multiple drug manufacturers were also covered in the black box warning list, including:

  • Harvoni from Gilead Sciences
  • Epclusa from Gilead Sciences
  • Technivie from AbbVie Inc
  • Viekira Pak & Viekira Pak XR from AbbVie Inc
  • Daklinza from Bristol-Myers Squibb
  • Xepatier from Merck Sharp Dohme
  • And Olysio from Johnson & Johnson & Janssen

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.