FDA Approves New Hepatitis C Drug
On Dec. 6, the FDA approved 400 mg. tablets of the drug Sovaldi (sofosbuvir) to treat hepatitis C. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon. Hepatitis C impacts an estimated 4 million Americans and is the leading cause of liver cancer and liver transplants in the United States.
"Today marks a landmark advance in the treatment of hepatitis C, opening up new opportunities to stop the spread of this virus and the ravages of this disease. However, new therapies only work if people receive treatment -- the potential of these and other treatment advances hinges entirely on our ability to get more people screened and into care," said John Ward, MD, Director of CDC’s Division of Viral Hepatitis.
Right now, most Americans with hepatitis C don’t access treatment because they have no idea they’re infected. Doctors believe that Sovaldi will have a major impact on public health by significantly increasing the number of Americans who are cured of hepatitis C.
"In clinical studies, Sovaldi in combination with other agents achieved very high cure rates while shortening the duration of treatment to as little as 12 weeks and reducing or completely eliminating the need for interferon injections, depending on the viral genotype," said Ira Jacobson, MD, Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York City and a principal investigator in the Sovaldi clinical trials.
In 2012, CDC recommended that all Baby Boomers (those born from 1945 through 1965) be tested for the hepatitis C virus. Boomers are five times more likely than other American adults to be infected.
In recent years, hepatitis has surpassed HIV/AIDS as a cause of death. The current standard of care for HCV involves up to 48 weeks of therapy with a pegylated interferon (peg-IFN)/ribavirin (RBV)-containing regimen, which may not suitable for certain types of patients.