New Hepatitis C Medication Studied by Northwestern Medicine Approved by FDA

Northwestern Medicine
Clinical Trials and Research December 10, 2013
On Dec. 6, the U.S. Food and Drug Administration (FDA) approved the use of sofosbuvir as part of two new medication regimens using previously approved drugs for the treatment of patients with hepatitis C, one regimen for the most common type of hepatitis C in the U.S. and another for patients with the less common types of the virus. Research has shown that the new regimens will cut treatment times substantially and provide higher cure rates, with around a 90 percent cure rate for patients with the most common type of hepatitis C.

The Northwestern Medicine® Transplantation Hepatology program was involved in the clinical trials submitted for the approval of sofosbuvir, and is continuing to participate in trials that aim to create further advancements in the treatment of hepatitis C using the new drug, sofosbuvir. These include a new all oral medication regimen for the common type of hepatitis C, with much fewer side effects and higher cure rates.

“The approval of these regimens is a monumental advance for the treatment of patients with hepatitis C,” said Steven Flamm, MD,medical director of Northwestern’s liver transplant program and lead researcher at Northwestern Medicine on the studies using sofosbuvir to produce new treatments for hepatitis C.

Hepatitis C is currently one of the leading causes of death in the U.S. and is the primary reason for liver transplantation. The U.S. Centers for Disease Control and Prevention (CDC) reports that an estimated 3.2 million Americans have a chronic hepatitis C virus infection. The CDC also reports that most individuals who have hepatitis C are not even aware they are infected.

Take a look at the following video to learn more about what this approval means for patients suffering from this deadly disease.