New drug to treat hepatitis C approved by FDA

U.S. Food and Drug Administration Approves Gilead’s Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C

Courtesy of Gilead

Gilead Science’s Sovaldi (Sofosbuvir) has received government approval for the treatment of chronic hepatitis C, meaning some patients will not have to deal with the severe side effects of the injected drug interferon.

U.S. regulators on Friday approved Gilead Sciences Inc’s Sovaldi, also known as sofosbuvir, as a potential cure for chronic infection with the liver-destroying hepatitis C virus.

The once-a-day pill is the first approved to treat certain types of hepatitis C infection without the need for interferon, an injected drug that can cause severe flu-like symptoms – but it comes at a steep price.

Most patients will be treated with the $ 7,000-a-week drug for 12 weeks, resulting in a total price of $ 84,000, according to Gilead spokeswoman Cara Miller.

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Hepatitis C, which is often undiagnosed, affects about 3.2 million Americans, killing more than 15,000 each year, mostly from illnesses such as cirrhosis and liver cancer.

“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,” Dr John Ward, director of the Centers for Disease Control and Prevention’s division of viral hepatitis, said in a statement.

Last year, the CDC recommended that all baby boomers, born from 1945 to 1965, be tested for the virus. Introduction of blood and organ screening in the 1990s has dramatically lowered infection rates for younger generations.

RELATED: MANY SLACK ON HEPATITIS C TESTING: CDC

Gilead said Sovaldi can be used in combination with ribavirin, an older antiviral pill, for patients with genotypes 2 and 3 infections, which account for about 28 percent of U.S. patients infected with the virus.

For patients with genotype 1, which accounts for about 70 percent of U.S. infections, the new drug must still be used with both interferon and ribavirin, although it can be considered for use in patients with genotype 1 infections who cannot use interferon.

Patients with the much less common genotype 4 infections must also still be treated with the 3-drug combination.

RELATED: HEPATITIS C IS ‘UNRECOGNIZED HEALTH CRISIS': CDC

The drug’s approval was supported by several studies showing that it helped to eradicate the virus in significantly more patients, with fewer side effects, than the current drug regimen.

Sovaldi is the first in a new class of medications known as nucleotide analogue inhibitors, or “nukes,” designed to block a specific protein that the hepatitis C virus needs to copy itself.

Gilead also announced Friday that it has launched a program for people who need financial assistance in order to access the drug.


Health – NY Daily News

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