FDA OKs Telaprevir for Hep C

[Guest guest]

http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/26638

FDA OKs Telaprevir for Hep C

By P. , Washington Correspondent, MedPage Today

Published: May 23, 2011

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 , 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, " 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 s-

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.

[Guest guest]

http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/26638

FDA OKs Telaprevir for Hep C

By P. , Washington Correspondent, MedPage Today

Published: May 23, 2011

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 , 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, " 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 s-

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.