Promise of Cure Signaled by FDA
American Liver Foundation Hails Promise of Cure Signaled by FDA’s Approval of New Hepatitis C Treatments
Treatments With Few Serious Side Effects Strengthen Case for Increased Screening, Which Could Save Many Lives
December 10, 2013
(New York, NY)
The American Liver Foundation fully welcomes FDA approval of two new treatments for Hepatitis C, one of which is a new class of drug. This liver disease affects approximately 3.2 million people in the United States, and roughly 75% of those infected are unaware they carry the virus. Often referred to as a silent epidemic, those infected include baby boomers that may have contracted the virus from surgeries, blood transfusions, and other contaminated blood products before the disease was known to exist.
Sovaldi, known generically as Sofosbuvir, is the first polymerase inhibitor to be approved for treatment of Hepatitis C, in combination with other anti?virals. Olysio, known generically as Simeprevir, is the first once?daily protease inhibitor to be approved.
“This is the beginning of a new, gentler, era in the treatment of Hepatitis C,” states Tom Nealon, National Board Chair of the American Liver Foundation. “We know that thousands of patients have been awaiting new, less invasive, treatment options, and this is exciting news, but we are concerned millions of cases of infections remain undetected and therefore untreated. These new treatments give hope to existing patients, and strengthen the case for systematically screening all baby boomers,” he adds.
New data from the manufacturers of these and other new drugs for Hepatitis C was presented at the recent AASLD conference in Washington DC, indicating that there are many more new treatments in pipeline, and promising the possibility of cure.
“With these new treatments just approved, and many more being developed, we have every reason to be optimistic about the potential to cure and even eradicate this deadly virus,” states Hillel Tobias, MD, a liver transplant specialist and Co?Chair of the American Liver Foundation’s National Medical Advisory Committee. “With these new treatments, it may be possible to lower the overall cost of treatment due to less side effects and hospitalizations that occurred from previous treatments. If we identify and treat patients with these new medications, it will be possible to prevent the need for many thousands of liver transplants,” he adds.
Both newly approved drugs promise shorter duration of treatment and reduced side?effects, with treatment regimens for some strains of Hepatitis C no longer requiring injections of Interferon, which has been the mainstay of treatment for many years, but is associated with some challenging side effects which can impact a person’s ability to work outside the home.
Between 3 and 4 million Americans are infected with Hepatitis C. Many of them are baby boomers who contracted the virus before Hepatitis C was known to exist, in the decades before the commencement of identification and screening in 1992. Other risk factors include tattoos, body piercings, and intravenous drug use.
Left untreated, Hepatitis C leads to liver cirrhosis and liver failure. 75% of patients do not know they have the disease, and 90% do not get treated. The American Liver Foundation hopes that awareness of these new, better?tolerated treatments will bring increased Hepatitis C screenings, testing and treatments.