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Vertex hepatitis C drug gets FDA okay: What will Incivek mean for liver patients?

incivek
Vertex Pharmaceuticals/Business Wire

incivek
Vertex Pharmaceuticals/Business Wire

(CBS/AP) The FDA has approved Vertex Pharmaceuticals' hepatitis C drug Incivek after aproving Merck's hep C drug Vicrelis just weeks go - and experts say the drug duo could usher in a new era in the treatment of a disease that is potentially deadly and notoriously hard to treat.

"There are now two important new treatment options for hepatitis C that offer a greater chance at a cure," said Edward Cox, director of the FDA drug center's office of antimicrobial products.

The agency approved Incivek (telaprevir) for patients who have liver damage from hepatitis C who either have not been treated, or were not cured by other drugs. Incivek is a twice-daily pill, making it more convenient than older intravenous therapies.

Incivek's side effects include rashes and anemia, the FDA said. The rash can be serious and can require stopping the drug.

Incivek is poised to nearly doubling the chances of curing the serious liver disease - and it comes at a high cost. Vertex set a wholesale price of $49,200 for a 12-week regimen of Incivek, which works in combination with current standard drugs pegylated interferon and ribavirin. The older treatments are then continued for as few as another 12 weeks.

Victrelis' wholesale price is $1,100 a week, or $26,400 to $48,400 for a course of treatment, depending on needed duration.

Vertex said it was initiating a co-pay assistance program that would reimburse the out-of-pocket costs for most patients covered by commercial health insurance, or about 60 percent of its expected patient mix.

In clinical studies, up to 79 percent of patients taking Incivek experienced a sustained virologic response - which is tantamount to a cure. Older drugs cure only about 40 percent of patients.

About 170 million people around the world are infected with hepatitis C, some 3.2 million of them in the U.S. The blood-borne disease can lead to liver cancer, cirrhosis, liver transplants, and death.

The National Institutes of Health has more on hepatitis C.