New hepatitis-C drug approved by FDA
Drug will make treating the condition faster and easier
Called sofosbuvir, and produced by Gilead Sciences Inc., liver specialists are now recommending this new medicine for chronic hepatitis C. Sofosbuvir can be paired with other drugs to make treatment of the debilitating disease faster, easier and more effective. Sofosbuvir won approval from the Food and Drug Administration last week.
Called sofosbuvir, and produced by Gilead Sciences Inc., liver specialists are now recommending this new medicine for chronic hepatitis C.
A deadly and sometimes fatal ailment, more than three million people in the united States are infected with the hepatitis C virus. Many have no symptoms until their livers begin to fail, causing jaundice, fatigue and other problems. Hepatitis C remains the nation's leading cause of liver cancer and liver transplants.
Up until now, standard three-drug treatments have taken 24 to 48 weeks and required self-injections of interferon. That drug at times can cause irritating flu-like symptoms and mood swings.
Under the brand name Sovaldi, Sofosbuvir will be the first treatment that some patients will be able to take for just 12 weeks with just one additional drug and no interferon.
The FDA approved the no-interferon combination for patients with two strains of the virus, genotypes 2 and 3. Patients with a more common strain, genotype 1, sofosbuvir is approved to be taken with interferon and an older drug called ribavirin.
There are the expected catches. Some patients still will have to be treated for 24 weeks - and none of the regimens are 100 percent effective.
In one study, 89 percent of genotype 1 patients who took the three-drug version were cured in 12 weeks, compared with 75 percent cured in longer-lasting available regimens.
Sofosbuvir does not add any obvious side effects to those already associated with the drugs it is paired with, Ira Jacobson, a liver specialist at Weill Cornell Medical College, New York says. Jacobson has led drug studies for Gilead.
As a result, patients taking it with ribavirin may experience fatigue and insomnia and those who also take interferon will have additional side effects, but for a shorter time than in the past, Jacobson says.
It comes at a substantial cost. The wholesale cost for a one-month supply of Solvadi will be $28,000, Gilead said in a press release.
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