Why Were There Hepatitis B Lawsuits?
There were hepatitis B lawsuits popping up because of the increase of hepatitis B virus reactivating in patients who were going through antiviral therapy. There has been a link shown between the use of certain hepatitis C anti-viral medications and the reactivation of hepatitis B.
Why Did Plaintiffs File Hepatitis B Lawsuits?
Plaintiffs claimed that the reactivation of hepatitis B comes from their treatment of hepatitis C. These drugs were supposed to help treat the effects of hepatitis C and the recurrence of hepatitis can prove deadly as there is no cure for the virus. This link was not shown during testing because individuals with HBV were not included in the clinical trials.
Which Drugs Are Associated with Hepatitis B Lawsuits?
The following medications have been linked to the reactivation of hepatitis B viruses:
- Harvoni
- Daklinza
- Epclusa
- Olysio
- Sovaldi
- Technivie
- Viekira Pak
- Vierkira Pak XR
- Zepatier
What Hepatitis B Lawsuits Were There?
The FDA was sued by public health groups, The Global Health Justice Partnership at Yale University and Treatment Action Group, for the release of clinical trials on Sovaldi. Both groups filed the suit on June 25, 2015, in a federal district court in Connecticut to enforce their Freedom of Information request and seek prompt disclosure of the clinical trial data, the release said. There has been no recorded update since 2015.
As a result of the companies’ failure to provide adequate warnings regarding the risk of liver damage from Viekira Pak, it was estimated that many users would receive compensation for their suffering. However, the litigation remained in the early stages and there has been little to no record of settlements or compensation provided to victims.
What Hepatitis B Lawsuit Settlements Have There Been?
As of 2023, there have been no documented cases of hepatitis B lawsuit settlements involving the anti-viral drugs listed above.
Are There Active Hepatitis B Lawsuits?
There are no active hepatitis B lawsuits associated with the anti-viral drugs and reactivation of hepatitis B in patients.
What Is Hepatitis B?
Hepatitis B is a serious liver infection and is caused by the hepatitis B virus that attacks the liver. This virus is transmitted through direct contact with infected blood or other infected bodily fluids. Patients may have hepatitis B without knowing and can then unknowingly transmit it through others since most people don’t experience symptoms when they’re newly infected or chronically infected. The only way to be sure you’re infected is through testing.
How Is Hepatitis B Treated?
Hepatitis B is incurable but treatable, meaning that most people with chronic hepatitis B will need treatment for the rest of their lives.
Treatment for chronic hepatitis B can include:
- Antiviral medications
- Interferon injections
- Liver transplant
What Is the Difference Between Hepatitis B and Hepatitis C?
Both hepatitis B and C are attacks on the liver, weakening the immune system. The difference between them is that hepatitis C is more deadly, leading to more chronic cases. Acute cases of hepatitis B can fade away after 6 months whereas people who contract hepatitis C are more likely to develop into chronic hepatitis.
What Are the Symptoms of Hepatitis B and C?
Most people who contract Hepatitis B don’t exhibit any symptoms for a while. However, when they do show up, they’re similar to the symptoms exhibited by patients with hepatitis C.
These symptoms may include:
- Fever
- Fatigue
- Loss of appetite
- Nausea
- Vomiting
- Dark urine
- Pale feces
- Joint pain
- Jaundice
What Are DAAs?
DAA stands for direct-acting antiviral agents. These DAAs were created and approved by the FDA to help treat the effects of hepatitis C. DAAs are expensive, leaving these drugs being exclusively used by those who can afford them. This is similar to other HCV treatments where treatment becomes limited to those who can afford to pay the price.
What Are the Side Effects of DAAs?
Side effects of DAAs can include:
- Anemia
- Diarrhea
- Fatigue
- Headaches
- Nausea
- Vomiting
- Slow heart rate
- Raised liver markers indicative of liver problems
What Side Effects Should DAA Users Look Out For?
Since DAAs have been linked to causing the reactivation of hepatitis B, doctors have warned their patients to look out for signs of serious liver problems.
Effects that may indicate serious liver damage include:
- Fatigue
- Loss of appetite
- Nausea and/or vomiting
- Yellow eyes and skin
- Light colored stool
If you show these signs of liver damage, be sure to contact your doctor.
What Are the FDA’s Warnings About DAAs?
The FDA is warning doctors and patients about the risk of hepatitis B virus becoming an active infection in any patient who has a current or previous infection and is treated with certain DAAs. Because of the increase in hepatitis B reactivation reports, the FDA has required these drugs to have a black box warning. This warning includes the risk of reactivating hepatitis B.
Healthcare professionals should screen all patients for evidence of current or prior infection before prescribing DAAs and monitor them as they take them. Patients should inform healthcare professionals of their medical history associated with hepatitis B or liver problems and always consult with their doctor.
Are DAAs Still on the Market?
Despite the link, the FDA only advises caution and has not required the medications to be taken off the market. The warning on the medications and the urged caution are the preventative measures the FDA has taken. Additionally, they have not recommended patients stop using DAAs, as DAAs are the only effective treatment of hepatitis C.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
Sources
- Geddawy, A., Ibrahim, Y., Elbahie, N. M., & Ibrahim, M. S. (2017). Direct acting anti-hepatitis C virus drugs: Clinical pharmacology and future direction. Journal of Translational Internal Medicine, 5(1), 8–17. https://doi.org/10.1515/jtim-2017-0007
- Hepatitis B – Diagnosis and treatment – Mayo Clinic. (2022, September 24). https://www.mayoclinic.org/diseases-conditions/hepatitis-b/diagnosis-treatment/drc-20366821
- Pisaturo, M., Macera, M., Alessio, L., Calò, F., & Coppola, N. (2019). Hepatitis B virus (HBV) reactivation following pharmacological eradication of hepatitis C virus (HCV). Viruses, 11(9), 850. https://doi.org/10.3390/v11090850
- Pockros, P. J. (2017, September 1). Black box warning for possible HBV reactivation during DAA therapy for chronic HCV infection. PubMed Central (PMC). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5635429/
- Research, C. F. D. E. A. (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. U.S. Food And Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-about-risk-hepatitis-b-reactivating-some-patients-treated
- Vandever, L. (2020, January 2). What are the side effects of hepatitis C treatment? Healthline. https://www.healthline.com/health/hepatitis-c/side-effects#side-effects
- What is Hepatitis B. (n.d.). https://www.hepb.org/what-is-hepatitis-b/what-is-hepb/
- What is the difference between hepatitis B and C? (n.d.). Drugs.com. https://www.drugs.com/medical-answers/difference-between-hepatitis-3559575/
- World Health Organization: WHO & World Health Organization: WHO. (2023). Hepatitis C. www.who.int. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c