New drugs take aim at hepatitis C, spur debate on whether to test baby boomers

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New drugs take aim at hepatitis C, spur debate on whether to test baby boomers

By n Neergaard (CP) – 1 day ago

WASHINGTON — There's new hope for an overlooked epidemic: Two powerful drugs are

nearing the market that promise to help cure many more people of liver-attacking

hepatitis C — even though most who have the simmering infection don't know it

yet.

Surprisingly, two-thirds of hepatitis C sufferers are thought to be baby boomers

who've harboured since their younger, perhaps wilder, years a virus that can

take two or three decades to do its damage.

What could be a treatment revolution is spurring the government to consider if

it's time to start screening aging baby boomers for hepatitis C, just like they

get various cancer checks.

" We're entering a whole new era of therapy, " says Dr. Ward, hepatitis chief

at the Centers for Disease Control and Prevention. " We really want to begin that

clarion call for action for this population who's at risk. "

Today's two-drug treatment for hepatitis C cures only about 40 per cent of

people with the most common variety of the virus, and causes some gruelling side

effects. Now major studies show that adding a new drug —either Vertex

Pharmaceuticals' telaprevir or Merck & Co.'s boceprevir — can boost those cure

rates as high as 75 per cent. And they allow some people to cut treatment time

in half, to six months, thus lessening how long they must deal with those side

effects.

If the Food and Drug Administration approves the drugs — a decision widely

expected this summer — they would be the first that work by directly targeting

the hepatitis C virus. Specialists draw comparisons to the early 1990s when

potent combination therapies emerged to treat AIDS. Many recently diagnosed

patients are postponing therapy to await these new drug cocktails in hopes of a

better chance at a faster cure, says Dr. Pockros, hepatology chief at the

Scripps Clinic in La Jolla, Calif., who helped test telaprevir.

However, the bigger impact could come if more people get tested for hepatitis C,

a blood-borne virus. It's often stigmatized as a risk only to people who inject

illegal drugs. But the virus could have begun festering from a blood transfusion

before 1992, when testing of the blood supply began.

Lapses in infection control in health facilities still occasionally expose

people today. So could even a one-time experiment with drugs way back in

college, something doctors are reluctant to ask a now middle-aged, button-downed

patient to reveal, says Ward.

" It cuts across every segment of society, " adds Dr. Arun Sanyal of Virginia

Commonwealth University, past president of the American Association for the

Study of Liver Diseases. " I can tell you our hepatitis C treatment clinic is a

great social equalizer. "

About 3.2 million Americans, and 170 million people worldwide, have chronic

hepatitis C. In the U.S., new infections have dropped dramatically — although

the disease's toll is rising as people infected decades earlier reach ages where

their livers start showing damage. Hepatitis C already is a leading cause of

liver transplants, and it kills about 12,000 U.S. patients a year, a number

expected to triple within 20 years.

Most people find out they're infected like Graham of Briarcliff Manor,

N.Y., during a routine check-up that spotted elevated liver enzymes. He'd never

heard of hepatitis C and had no obvious risk factors. But tests showed the virus

had begun to scar his liver. So over the last decade he tried three rounds of

traditional treatments, with increasingly tough side effects, to no avail.

" I didn't want to die of liver disease or cancer or suffer the prospect of

having to tee up for a liver transplant. Scary stuff, " says Graham, now 56.

Enter the new drugs. They work by blocking an enzyme named protease that's key

for the virus to reproduce. But they must be taken together with standard

medications — ribavirin pills plus injections of interferon-alpha — that are

thought to boost the immune system.

According to studies presented at a recent medical meeting, 67 per cent to 75

per cent of patients given treatment including either boceprevir or telaprevir,

respectively, had what doctors call a cure. That's defined as no sign of the

hepatitis C virus six months after their last dose. Importantly, only about a

quarter of black patients are helped by standard therapy but adding one of the

new drugs more than doubled their cure rates.

People getting their first-ever treatment did best, but the studies also found

improvements in hard-to-treat patients like Graham.

" The fourth time did the trick, " says Graham, who volunteered for an early

telaprevir study and says he's been hepatitis-free for three years.

The new drugs do add side effects to the flulike symptoms and other complaints

of existing treatment. Telaprevir's main risk is a rash that is sometimes

severe, and boceprevir's is anemia.

" The future looks very bright beyond telaprevir and boceprevir, " notes Dr. Fred

Poordad of Cedars-Sinai Medical Center in Los Angeles, who has studied both

drugs and consults for several companies. He points to additional drugs in

earlier-stage testing that promise to target more types of hepatitis C and

perhaps eventually allow for pill-only, interferon-free treatment.

Manufacturers haven't said how much the new drugs will add to the price of

treatment that already can cost US$30,000, albeit far cheaper than a liver

transplant.

A stickier issue: Not everyone suffers serious liver damage and it's hard to

predict who will, raising questions about exactly who needs treatment even as

drug companies help push for more screening. "

That's a concern, acknowledges Jeff Levi of the non-profit Trust for America's

Health, also a screening proponent. But when to treat is a doctor-patient

decision, and " anyone with chronic infection you do want to be monitoring so you

can intervene at the right moment, " he adds.

Plus, people with hepatitis C should avoid alcohol and consider other

liver-protection steps — and know how to avoid infecting others, he stresses.

Stay tuned: The CDC has begun a study at four hospitals — in New York, Detroit,

Houston and Birmingham, Ala. — to see if a one-time hepatitis C test for baby

boomers makes sense. Among the boomers, black men in their 50s are at particular

risk. CDC plans new guidelines next year.

Meanwhile, " start that conversation " at a routine doctor's visit by asking about

hepatitis C risks and testing, Ward advises boomers.

___

EDITOR's NOTE — n Neergaard covers health and medical issues for The

Associated Press in Washington.

Copyright © 2011 The Canadian Press. All rights reserved.

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2dHURUBwA?docId=5676894

New drugs take aim at hepatitis C, spur debate on whether to test baby boomers

By n Neergaard (CP) – 1 day ago

WASHINGTON — There's new hope for an overlooked epidemic: Two powerful drugs are

nearing the market that promise to help cure many more people of liver-attacking

hepatitis C — even though most who have the simmering infection don't know it

yet.

Surprisingly, two-thirds of hepatitis C sufferers are thought to be baby boomers

who've harboured since their younger, perhaps wilder, years a virus that can

take two or three decades to do its damage.

What could be a treatment revolution is spurring the government to consider if

it's time to start screening aging baby boomers for hepatitis C, just like they

get various cancer checks.

" We're entering a whole new era of therapy, " says Dr. Ward, hepatitis chief

at the Centers for Disease Control and Prevention. " We really want to begin that

clarion call for action for this population who's at risk. "

Today's two-drug treatment for hepatitis C cures only about 40 per cent of

people with the most common variety of the virus, and causes some gruelling side

effects. Now major studies show that adding a new drug —either Vertex

Pharmaceuticals' telaprevir or Merck & Co.'s boceprevir — can boost those cure

rates as high as 75 per cent. And they allow some people to cut treatment time

in half, to six months, thus lessening how long they must deal with those side

effects.

If the Food and Drug Administration approves the drugs — a decision widely

expected this summer — they would be the first that work by directly targeting

the hepatitis C virus. Specialists draw comparisons to the early 1990s when

potent combination therapies emerged to treat AIDS. Many recently diagnosed

patients are postponing therapy to await these new drug cocktails in hopes of a

better chance at a faster cure, says Dr. Pockros, hepatology chief at the

Scripps Clinic in La Jolla, Calif., who helped test telaprevir.

However, the bigger impact could come if more people get tested for hepatitis C,

a blood-borne virus. It's often stigmatized as a risk only to people who inject

illegal drugs. But the virus could have begun festering from a blood transfusion

before 1992, when testing of the blood supply began.

Lapses in infection control in health facilities still occasionally expose

people today. So could even a one-time experiment with drugs way back in

college, something doctors are reluctant to ask a now middle-aged, button-downed

patient to reveal, says Ward.

" It cuts across every segment of society, " adds Dr. Arun Sanyal of Virginia

Commonwealth University, past president of the American Association for the

Study of Liver Diseases. " I can tell you our hepatitis C treatment clinic is a

great social equalizer. "

About 3.2 million Americans, and 170 million people worldwide, have chronic

hepatitis C. In the U.S., new infections have dropped dramatically — although

the disease's toll is rising as people infected decades earlier reach ages where

their livers start showing damage. Hepatitis C already is a leading cause of

liver transplants, and it kills about 12,000 U.S. patients a year, a number

expected to triple within 20 years.

Most people find out they're infected like Graham of Briarcliff Manor,

N.Y., during a routine check-up that spotted elevated liver enzymes. He'd never

heard of hepatitis C and had no obvious risk factors. But tests showed the virus

had begun to scar his liver. So over the last decade he tried three rounds of

traditional treatments, with increasingly tough side effects, to no avail.

" I didn't want to die of liver disease or cancer or suffer the prospect of

having to tee up for a liver transplant. Scary stuff, " says Graham, now 56.

Enter the new drugs. They work by blocking an enzyme named protease that's key

for the virus to reproduce. But they must be taken together with standard

medications — ribavirin pills plus injections of interferon-alpha — that are

thought to boost the immune system.

According to studies presented at a recent medical meeting, 67 per cent to 75

per cent of patients given treatment including either boceprevir or telaprevir,

respectively, had what doctors call a cure. That's defined as no sign of the

hepatitis C virus six months after their last dose. Importantly, only about a

quarter of black patients are helped by standard therapy but adding one of the

new drugs more than doubled their cure rates.

People getting their first-ever treatment did best, but the studies also found

improvements in hard-to-treat patients like Graham.

" The fourth time did the trick, " says Graham, who volunteered for an early

telaprevir study and says he's been hepatitis-free for three years.

The new drugs do add side effects to the flulike symptoms and other complaints

of existing treatment. Telaprevir's main risk is a rash that is sometimes

severe, and boceprevir's is anemia.

" The future looks very bright beyond telaprevir and boceprevir, " notes Dr. Fred

Poordad of Cedars-Sinai Medical Center in Los Angeles, who has studied both

drugs and consults for several companies. He points to additional drugs in

earlier-stage testing that promise to target more types of hepatitis C and

perhaps eventually allow for pill-only, interferon-free treatment.

Manufacturers haven't said how much the new drugs will add to the price of

treatment that already can cost US$30,000, albeit far cheaper than a liver

transplant.

A stickier issue: Not everyone suffers serious liver damage and it's hard to

predict who will, raising questions about exactly who needs treatment even as

drug companies help push for more screening. "

That's a concern, acknowledges Jeff Levi of the non-profit Trust for America's

Health, also a screening proponent. But when to treat is a doctor-patient

decision, and " anyone with chronic infection you do want to be monitoring so you

can intervene at the right moment, " he adds.

Plus, people with hepatitis C should avoid alcohol and consider other

liver-protection steps — and know how to avoid infecting others, he stresses.

Stay tuned: The CDC has begun a study at four hospitals — in New York, Detroit,

Houston and Birmingham, Ala. — to see if a one-time hepatitis C test for baby

boomers makes sense. Among the boomers, black men in their 50s are at particular

risk. CDC plans new guidelines next year.

Meanwhile, " start that conversation " at a routine doctor's visit by asking about

hepatitis C risks and testing, Ward advises boomers.

___

EDITOR's NOTE — n Neergaard covers health and medical issues for The

Associated Press in Washington.

Copyright © 2011 The Canadian Press. All rights reserved.