Major Cardiovascular Events Recorded in Hepatitis C Clinical Trials
As pharmaceutical companies struggle to create the next generation of hepatitis C treatments, it has become clear that one of the biggest hurdles is creating a drug that will treat the deadly disease while also minimizing the potential of patients suffering serious adverse events.
A Global View of Hepatitis C
Hepatitis C is a debilitating and potentially fatal condition in which the hepatitis virus causes the liver to swell and, as the infection spreads, develop scarring. Ultimately, this can lead to cirrhosis, liver failure, liver cancer and death.
The U.S Centers for Disease Control and Prevention estimates that 180 million people around the world are infected with hepatitis C, and the disease kills 350,000 people every year. Still worse, the CDC believes that up to 75 percent of those infected are not even aware they are HCV positive.
This is due to hepatitis C infections being asymptomatic. Because the liver is a non-complaining organ, meaning patients will not feel pain or discomfort in the early stages of liver damage, most HCV diagnoses come very late, and, while treatment is available, current hepatitis C regiments, costing between $15,000 and $49,000, only have a 46% to 79% chance of successfully eradicating the virus.
Despite the high costs and low success rates, the hepatitis C market has maintained an estimated worth of $5 billion; however, it is believed that a new generation of less evasive treatments could generate up to $20 billion in sales.
Cardiovascular Events in Hepatitis C Trials
As multiple pharmaceutical companies contend to claim the second generation hepatitis C drug market, it can be easy to get lost in the hype, and overlook the risks associated with their drug trials – most significant, reports of heart attacks, stroke and death.
Previously, adverse events such as these have resulted in the suspension and termination of clinical trials. Perhaps most significant were reports of cardiovascular events which left one person dead and eight others hospitalized during the development of BMS-986094.
As a result of these reports, similar compounds including IDX-19368 and IDX-184, were also halted and, after Index decided not to pursue studies to prove the drugs’ safety, terminated.
Contact an Experienced Clinical Trial Attorney
Thomas J. Henry are leaders in the area clinical trial litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. Our Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.
If you or a loved one have been injured by or have developed serious side-effects while participating in a clinical trial, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.