A landmark drug is being manufactured by Gilead Sciences Inc. for the treatment of the deadliest liver infection. The drug is named as sofosbuvir (brand name Sovaldi), which will cost $1,000 per pill. Sofosbuvir is the first all-oral, interferon-free regimen approved for treating chronic Hepatitis C.
The New Drug Application for Sofosbuvir was submitted on April 8, 2013 and received the FDA’s Breakthrough Therapy Designation, which grants priority review status to drug candidates that may offer major treatment advantages over existing options. On 6th December 2013, the U.S. Food and Drug Administration approved sofosbuvir for the treatment of chronic hepatitis C.
A researcher from The Department of Pharmacology and Therapeutics, Andrew Hill at the University of Liverpool, says $84,000 per cure is too much, based on his estimate of Gilead’s cost to produce the drug. But Gilead’s Vice president Greg Alton, says the high price is fully justified.
He also says “We’re just looking at what we think was a fair price for the value that we’re bringing into the health care system and to the patients.”
Curing hepatitis C has been difficult, involving regimens that don’t work as well as with harsh side effects. More than 90 percent of patients who get the new drug can expect to be cured of their hepatitis C infection, with few side effects.
A typical course of treatment will last 12 weeks and run $84,000, plus the cost of necessary companion drugs. Some patients may need treatment for twice as long.
The World Health Organization estimates there are 184 million people infected with hepatitis C worldwide through sources such as transfusions, with the disease causing half a million deaths annually. WHO estimates that about 3% of the world’s population has been infected with HCV.
More than 3 million Americans are infected with hepatitis C, and around 12.2 million HCV (hepatitis C Virus) carriers in India*(1). This infects three to five times more people than HIV.
Gilead Sciences is an independent biotech company that prides itself on its commitment to corporate responsibility to make its drugs accessible to patients who can’t afford them. The company’s page on Sovaldi promises help for patients who can’t afford the drug. Hopefully, this brings new change in the medical field.
By Akshatha Karthik