The FDA approves telaprevir to treat hepatitis C, the second drug approved in two weeks

The Food and Drug Administration on Monday approved telaprevir for the treatment of hepatitis C, the second drug for the disease approved in two weeks.

On May 13, the agency approved boceprevir, sold under the brand name Victrelis. The two drugs are the first new treatments for hepatitis C in 20 years. Both are members of a new class of drugs called protease inhibitors that block replication of an enzyme that is crucial to the replication of the virus. Like boceprevir, telaprevir, sold under the brand name Incivek by Vertex Pharmaceuticals Inc. of Cambridge, Mass., is meant to be used only in conjunction with the standard therapy of peginterferon-alpha and ribavirin.

An estimated 3.2 million Americans have chronic hepatitis C infections, according to the Centers for Disease Control and Prevention. The virus causes inflammation of the liver that can lead to diminished liver function or failure. Most people have no symptoms until the liver fails, which can take years. The majority of liver transplants in the United States are a result of damage caused by the virus. Infection can also lead to cancer. The virus is transmitted primarily through blood and during sex.

Telaprevir was studied in about 2,250 hepatitis C patients who had not yet received treatment or in whom conventional treatment had failed. In combination with peginterferon-alpha and ribavirin, the drug produced a sustained virologic suppression--in effect, a cure--in 79% of patients, as much as 45% more than among patients who received only the standard of care. The sustained response was achieved in 24 weeks, compared with the 48 weeks required for conventional treatment.

The most common reported side effects of the combination therapy included rash, anemia, nausea, fatigue, headache, diarrhea, itching and anal or rectal irritation and pain. The rash can become serious and require stopping treatment with all three drugs.

Vertex said it will provide the drug free to people with no insurance and a household income of less than $100,000 per year. For those who have private insurance, the company will pay the co-pay up to 20% of the cost of the drug, regardless of household income. For those who have government insurance, the company will make a voluntary contribution to the Patient Access Network Foundation, which helps people taking hepatitis C medicines.