December 8, 2013
FDA Approves New Treatment For Chronic Hepatitis C
redOrbit Staff & Wire Reports – Your Universe Online
According to Kim Painter of USA Today, the medication is manufactured by Gilead Sciences and “can be paired 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 shift in the treatment paradigm for some patients with chronic hepatitis C.” The drug is the second to get the go-ahead from the FDA to treat the condition in less than a month, following the November 22 approval of Olysio (simeprevir).
The drug, which will be available in pill form, will allow some of the over three million Americans to be treated without co-administration of interferon, which can have flu-like side effects, the Wall Street Journal added. In clinical trials, Sovaldi was found to cure hepatitis C in 90 percent of patients when used in tandem with one or more other drugs, which varied based on the specific type of the disease those individuals had contracted.
However, “the greater convenience and effectiveness comes at a price,” New York Times reporter Andrew Pollack wrote. “Gilead said the wholesale cost of Sovaldi… would be $28,000 for four weeks – or $1,000 per daily pill. That translates to $84,000 for the 12 weeks of treatment recommended for most patients, and $168,000 for the 24 weeks needed for a hard-to-treat strain of the virus.”
Michael Weinstein, president of the AIDS Healthcare Foundation, told Pollack the cost was “completely unjustified,” but Gilead countered that the price was fair in light of the medication’s high cure rate. Furthermore, the pharmaceutical company said the overall cost for the three-month regimen was “consistent with, and in some cases lower than” the cost of other hepatitis C treatments, and that financial assistance would be available to some patients.
Sovaldi is described by the FDA as a nucleotide analog inhibitor, which blocks a protein required for the hepatitis C virus to replicate. It is to be used as one part of a combination treatment for chronic infection, and is to be taken in conjunction with peginterferon-alfa and/or ribavirin. The six clinical trials used to evaluate it involved nearly 2,000 patients who had either not received treatment or had not responded to 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 that this is 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, he also emphasized these treatments are only effective if they can get “more people screened and into care. Right now, most Americans with hepatitis C don't access treatment because they have no idea they're infected.”