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.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Screening is critical because the disease often has no symptoms and the vast majority of those infected (up to 3 out of 4) don't know it. The longer the virus goes undetected, the greater a person's chances of developing serious liver disease, including liver cancer and cirrhosis.

"CDC continues to urge every Baby Boomer in America and others at risk to get tested for hepatitis C," said Ward. "Widespread screening, together with new cures, promises to slash the burden of hepatitis C in this country and save thousands of lives."

Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. It is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection. To date, nearly 3,000 patients have received at least one dose of Sovaldi in Phase 2 or 3 studies. Sovaldi combination therapy was well tolerated in clinical studies. Adverse events were generally mild and there were few treatment discontinuations due to adverse events. The most common adverse events occurring in at least 20 percent of patients receiving Sovaldi in combination with Peg-IFN/RBV were fatigue, headache, nausea, insomnia and anemia.

Sovaldi is the third drug with breakthrough therapy designation to receive FDA approval. A breakthrough therapy drug is one in which preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Sovaldi was reviewed under the FDA's priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

"It is our hope that Sovaldi will mark the beginning of a new era in hepatitis C treatment. Gilead is proud to have played a role in bringing about this important therapeutic advance and we would like to extend our thanks to the many patients and physicians who partnered with us on Sovaldi's clinical studies," said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences.

For more information, visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377888.htm