FDA OKs Telaprevir for Hep C

FDA OKs Telaprevir for Hep C

WASHINGTON -- The FDA has approved telaprevir (Incivek) for treatment of hepatitis C genotype 1, making it the second new protease inhibitor to win agency approval for the condition this month.

Hepatitis C affects some three to four million people in the U.S.; about two-thirds have genotype 1.

The approval was all but certain after an FDA advisory committee unanimously endorsed telaprevir, made by Vertex Pharmaceuticals, in April. On May 13, the agency announced it is approving Merck's boceprevir (Victrelis).

Telaprevir and boceprevir work by targeting the virus directly; the current standard treatment regimen of pegylated interferon and ribavirin works instead by boosting patients' immune responses.

Both telaprevir and boceprevir are indicated as add-on treatment to pegylated interferon and ribavirin.

Telaprevir comes in pill form and is taken three times a day for 12 weeks, with peginterferon and ribavirin at standard doses for 24 or 48 weeks, depending on virologic response.

Adding a protease inhibitor to peginterferon and ribavirin is expected to become the new standard of care for HCV genotype 1 patients.

About half of patients treated with the standard peginterferon and ribavirin combo achieve sustained viral responses. The telaprevir trials indicated that adding the protease inhibitor could boost the sustained response rate above 70%, to as much as 90%, in patients who had never been treated for HCV, according to results from one study.

"With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition," said Edward Cox, MD, MPH, director of the FDA's Office of Antimicrobial Products.

"The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection," Cox said.

The FDA advisory panel that reviewed telaprevir was extremely confident that the drug works but was concerned about an increased incidence of serious and life-threatening skin reactions, including three cases of Stevens-Johnson syndrome in patients who took telaprevir.

More than half of patients receiving the drug reported rash or pruritus, with 6% discontinuing treatment as a result. These rates were about double those in the control groups.

Vertex assured the panel that those side effects are generally manageable and resolve after the drug is stopped.

http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/26638
~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Telaprevir Patient Assistance Program

Helping People with Hepatitis C Get INCIVEK

The people who work at Vertex understand that medicines can only help patients who can get them. With that in mind, the company today introduced a comprehensive financial assistance and patient support program to help people get INCIVEK who might not otherwise be able to afford it. The program will help people with hepatitis C learn about insurance benefits for their medicines, give INCIVEK for free to eligible patients who do not have insurance and provide coverage for co-pay or co-insurance costs associated with INCIVEK for people who meet certain program criteria.

Additionally, patients will have access to nurses through a 24-7 hotline by which they can receive support, guidance and educational materials about hepatitis C and its treatment. Vertex will also provide nurses and doctors with educational tools and resources so they can offer support and care to people with hepatitis C before, during and after the treatment process.

For eligible patients, the program includes the following:

Insurance Benefits Research and Support: Vertex case managers will research patients' insurance benefits for INCIVEK combination treatment, assist people with insurance appeals and help guide them to other forms of financial support, including Vertex's free medicine and co-pay programs;
Free Medicine Program: Vertex will give INCIVEK for free to people who do not have insurance and have an annual household income of $100,000 or less; and
Co-Pay Support: Vertex will cover co-pay or co-insurance costs up to 20 percent of the total cost of INCIVEK for people who have private insurance plans that cover INCIVEK, regardless of their household income. For people covered by government insurance, Vertex will also make donations to the independent, non-profit Patient Access Network Foundation, which has a fund to provide co-pay support to people taking hepatitis C medicines.

More information about this program is available by calling 1-855-837-8394 or visiting www.INCIVEK.com