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Sovaldi (sofosbuvir), a brand new drug that may treat hepatitis C infections, has been approved on the market through the US Fda (FDA), agency officials confirmed on Friday.
According to Kim Painter of USA Today, its manufactured by Gilead Sciences and “can be combined with other drugs to make treatment of the liver-damaging disease faster, easier and more effective.”
Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, called the approval “a significant transfer of the treatment paradigm for some patients with chronic hepatitis C.” The medication is the 2nd to get the go-ahead from the FDA to deal with the problem in under a month, following the November 22 approval of Olysio (simeprevir).
The drug, which will be available in pill form, will allow a few of the over three million Americans to become treated without co-administration of interferon, which can have flu-like negative effects, the Wall Street Journal added. In numerous studies, Sovaldi was discovered to cure hepatitis C in 90 percent of patients when utilized in tandem with one or more other drugs, which varied in line with the specific kind of the disease those individuals had contracted.
However, “the greater convenience and effectiveness comes at a price,” Ny Times reporter Andrew Pollack wrote. “Gilead said the wholesale price of Sovaldi- would be $28,000 for four weeks C or $1,000 per daily pill. That means $84,000 for the 12 weeks of treatment suitable for most sufferers, and $168,000 for that 24 weeks needed for a hard-to-treat strain of the virus.”
Michael Weinstein, president of the AIDS Healthcare Foundation, told Pollack the price was “completely unjustified,” but Gilead countered the price was fair considering the medication’s high cure rate. Furthermore, the pharmaceutical company said the total cost for the three-month regimen was “consistent with, and perhaps lower than” the cost of other hepatitis C treatments, which financial help would be open to some patients.
Sovaldi is explained the FDA as a nucleotide analog inhibitor, which blocks a protein necessary for the hepatitis C virus to duplicate. It’s for use as you a part of a combination strategy to chronic infection, and it is to become taken in addition to peginterferon-alfa and/or ribavirin. The six clinical trials used to review it involved nearly 2,000 patients who had either not received treatment or had not taken care of immediately previous treatment attempts.
Dr. John Ward, director of the Division of Viral Hepatitis at the US Centers for Disease Control and Prevention (CDC), told CNN this is really a “landmark advance within the management of hepatitis C, opening up new opportunities to steer clear of the spread of this virus and also the ravages of this disease.” However, he also emphasized these remedies are only effective if they can get “more people screened and into care. At this time, most Americans with hepatitis C don’t access treatment simply because they have no idea they’re infected.”
