2 Articles on Hep C Treatment with New Drugs

[Guest guest]

CDC 05-24-11

UNITED STATES: " Second Drug Wins Approval for Treatment of Hepatitis C "

New York Times (05.24.11):: Pollack

On Monday, the Food and Drug Administration approved Vertex Pharmaceuticals’

Incivek (telaprevir), the second new hepatitis C treatment OK’d this month.

Incivek is taken with traditional HCV drugs and is approved for treatment-naïve

patients and those whose infection has not responded adequately to previous

therapies, FDA said.

In clinical trials, 79 percent of patients taking Incivek-based combination

therapy achieved a sustained virologic response. This SVR rate is between 20

percent and 45 percent higher than that achieved by patients taking traditional

interferon and ribavirin therapy alone, FDA said.

About half of patients taking Incivek-based combination therapy were able to

finish treatment in 24 weeks rather than the typical 48 weeks. Of

treatment-naïve patients, 60 percent achieved an early response, received only

24 weeks of therapy, and had an overall SVR of 90 percent.

Incivek is taken three times a day (six pills total), and an entire course of

treatment is $49,200 wholesale. Merck’s HCV drug approved earlier this month,

Victrelis (boceprevir), costs $26,400-$48,400 depending on the duration of

treatment. Both of the new HCV protease inhibitors are taken with standard

treatment, which costs about $15,000-$30,000, depending on treatment duration.

The most commonly reported side effects in patients taking Incivek-based

combination therapy were rash, anemia, nausea, fatigue, headache, diarrhea,

itching, and anal or rectal irritation or pain, FDA said. The rash can be severe

enough to stop Incivek or all the drugs.

The new HCV drugs “represent a new direction in the treatment of hepatitis C and

a significant improvement over the current standard of care,” said Dr. Margaret

A. Hamburg, the commissioner of FDA.

Efforts to diagnose HCV are expected to get a boost, since many of the 3.2

million Americans with the virus are unaware of their infection. Vertex’s public

awareness campaign may initially focus on New York City.

For more information, visit:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256299.htm.

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UNITED STATES: " The Race to Treat Hepatitis C Isn't Over: Merck's Victrelis Is

First New Medicine to Get OK "

Star-Ledger (Newark) (05.15.11):: Todd

Most major drug developers are now angling for a piece of the hepatitis C

treatment market, which is expected to balloon with the improved treatment

responses of new combination regimens.

“There are patients lined up waiting for new drugs,” said Eliav Barr, vice

president of infectious diseases at Merck, which recently gained approval for

Victrelis (boceprevir). “There are people getting liver transplants and liver

cancer. That’s where the pressure was coming from.”

CDC estimates 3.2 million people in the United States have chronic hepatitis C

virus, two-thirds of them baby boomers. Many discover they have HCV only when

they purchase life insurance and lab results indicate the presence of HCV

antibodies, said Palmer, medical director of hepatology at NYU

Hepatology Associates in Long Island.

“People may have non-specific symptoms like fatigue, so they don’t really know

what it is,” Palmer said.

Two-thirds of patients taking Victrelis-based therapy achieved a sustained

virological response, as did 79 percent of those on a regimen including Incivek

(telaprevir), the new HCV treatment from Vertex Pharmaceuticals. By comparison,

only about 40 percent of patients receiving ribavirin and peginterferon

combination therapy alone achieved SVR. With both new therapies, many patients

were successfully treated in a shorter amount of time, as well.

“I think we’ve set a really high bar,” said Camilla Graham, vice president of

global medical affairs at Vertex. “We’re looking for high cure rates for as

short a treatment period as possible. To be able to shorten the treatment period

to 24 weeks is a big step forward.”

“The researchers want to copy the playbook of HIV and hit [HCV] at every step of

the life cycle,” said Seamus Levine-Wilkinson, a Decision Resources analyst.

“That’s why the combination therapies are the focus of everyone.”

The crowning achievement will be an all-oral therapy that excludes interferon,

said Barr. “The field is working hard in that direction,” he added.

[Guest guest]

CDC 05-24-11

UNITED STATES: " Second Drug Wins Approval for Treatment of Hepatitis C "

New York Times (05.24.11):: Pollack

On Monday, the Food and Drug Administration approved Vertex Pharmaceuticals’

Incivek (telaprevir), the second new hepatitis C treatment OK’d this month.

Incivek is taken with traditional HCV drugs and is approved for treatment-naïve

patients and those whose infection has not responded adequately to previous

therapies, FDA said.

In clinical trials, 79 percent of patients taking Incivek-based combination

therapy achieved a sustained virologic response. This SVR rate is between 20

percent and 45 percent higher than that achieved by patients taking traditional

interferon and ribavirin therapy alone, FDA said.

About half of patients taking Incivek-based combination therapy were able to

finish treatment in 24 weeks rather than the typical 48 weeks. Of

treatment-naïve patients, 60 percent achieved an early response, received only

24 weeks of therapy, and had an overall SVR of 90 percent.

Incivek is taken three times a day (six pills total), and an entire course of

treatment is $49,200 wholesale. Merck’s HCV drug approved earlier this month,

Victrelis (boceprevir), costs $26,400-$48,400 depending on the duration of

treatment. Both of the new HCV protease inhibitors are taken with standard

treatment, which costs about $15,000-$30,000, depending on treatment duration.

The most commonly reported side effects in patients taking Incivek-based

combination therapy were rash, anemia, nausea, fatigue, headache, diarrhea,

itching, and anal or rectal irritation or pain, FDA said. The rash can be severe

enough to stop Incivek or all the drugs.

The new HCV drugs “represent a new direction in the treatment of hepatitis C and

a significant improvement over the current standard of care,” said Dr. Margaret

A. Hamburg, the commissioner of FDA.

Efforts to diagnose HCV are expected to get a boost, since many of the 3.2

million Americans with the virus are unaware of their infection. Vertex’s public

awareness campaign may initially focus on New York City.

For more information, visit:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256299.htm.

Back to Top

UNITED STATES: " The Race to Treat Hepatitis C Isn't Over: Merck's Victrelis Is

First New Medicine to Get OK "

Star-Ledger (Newark) (05.15.11):: Todd

Most major drug developers are now angling for a piece of the hepatitis C

treatment market, which is expected to balloon with the improved treatment

responses of new combination regimens.

“There are patients lined up waiting for new drugs,” said Eliav Barr, vice

president of infectious diseases at Merck, which recently gained approval for

Victrelis (boceprevir). “There are people getting liver transplants and liver

cancer. That’s where the pressure was coming from.”

CDC estimates 3.2 million people in the United States have chronic hepatitis C

virus, two-thirds of them baby boomers. Many discover they have HCV only when

they purchase life insurance and lab results indicate the presence of HCV

antibodies, said Palmer, medical director of hepatology at NYU

Hepatology Associates in Long Island.

“People may have non-specific symptoms like fatigue, so they don’t really know

what it is,” Palmer said.

Two-thirds of patients taking Victrelis-based therapy achieved a sustained

virological response, as did 79 percent of those on a regimen including Incivek

(telaprevir), the new HCV treatment from Vertex Pharmaceuticals. By comparison,

only about 40 percent of patients receiving ribavirin and peginterferon

combination therapy alone achieved SVR. With both new therapies, many patients

were successfully treated in a shorter amount of time, as well.

“I think we’ve set a really high bar,” said Camilla Graham, vice president of

global medical affairs at Vertex. “We’re looking for high cure rates for as

short a treatment period as possible. To be able to shorten the treatment period

to 24 weeks is a big step forward.”

“The researchers want to copy the playbook of HIV and hit [HCV] at every step of

the life cycle,” said Seamus Levine-Wilkinson, a Decision Resources analyst.

“That’s why the combination therapies are the focus of everyone.”

The crowning achievement will be an all-oral therapy that excludes interferon,

said Barr. “The field is working hard in that direction,” he added.