CDC makes recommendation for HCV testing...

Posted 8/16/2012 on the CDC website. This new CDC recommendation that all of those born between 1945 and 1965 get tested for Hepatitis C is critical for HCV drug developers in that it will drive patients for the 2nd and 3rd wave of therapies currently in development. The recommendation is as important as the recommendation for colon cancer screening and, with proper mainstream media leverage, has the potential to drive patients into physician offices in similar volume. The upside is a potential second surge with current therapy and certainly immense anticipation for the simpler, more tolerable pan-genotypic 2nd and 3rd waves of HCV therapy currently in development. The potential downside is that the sheer number of patients may be the tipping point for an already overloaded and politically charged health care system short on resources.

CDC Now Recommends All Baby Boomers Receive One-Time Hepatitis C Test

New approach will help avert major increases in liver disease and deaths in the U.S.

All U.S. baby boomers should get a one-time test for the hepatitis C virus, according to final recommendations published today by the Centers for Disease Control and Prevention. One in 30 baby boomers – the generation born from 1945 through 1965 – has been infected with hepatitis C, and most don’t know it. Hepatitis C causes serious liver diseases, including liver cancer (the fastest-rising cause of cancer-related deaths) and is the leading cause of liver transplants in the United States.

The final recommendations are published in today’s issue of CDC’s Morbidity and Mortality Weekly Report. Draft recommendations were issued in May, followed by a public comment period.

“A one-time blood test for hepatitis C should be on every baby boomer’s medical checklist,” said CDC Director Thomas R. Frieden, M.D., M.P.H. “The new recommendations can protect the health of an entire generation of Americans and save thousands of lives.”

CDC’s previous recommendations called for testing only individuals with certain known risk factors for hepatitis C infection. Risk-based screening will continue to be important, but is not sufficient alone. More than 2 million U.S. baby boomers are infected with hepatitis C – accounting for more than 75 percent of all American adults living with the virus. Studies show that many baby boomers were infected with the virus decades ago, do not perceive themselves to be at risk, and have never been screened.

More than 15,000 Americans, most of them baby boomers, die each year from hepatitis C-related illness, such as cirrhosis and liver cancer, and deaths have been increasing steadily for over a decade and are projected to grow significantly in coming years.

CDC estimates one-time hepatitis C testing of baby boomers could identify more than 800,000 additional people with hepatitis C. And with newly available therapies that can cure up to 75 percent of infections, expanded testing – along with linkage to appropriate care and treatment – would prevent the costly consequences of liver cancer and other chronic liver diseases and save more than 120,000 lives.

Comments received from individuals and organizations during the public comment period (May 22-June 8, 2012) overwhelmingly supported CDC’s original proposal. As a result, the agency did not make substantive changes to the draft recommendations.

For additional information about hepatitis, visit www.cdc.gov/hepatitis.

LA Times: "Baby boomers should get tested for hepatitis C, federal officials say"

(Article in the LA Times posted on 5/2/12. Should put HCV drug developers in exceptionally good moods going into the weekend.)

Baby boomers should get tested for hepatitis C, federal officials say
May 2, 2012 | 10:52 am

Federal health officials plan to issue new recommendations that all baby boomers get tested for hepatitis C, a blood-borne virus that can lead to liver cancer, liver failure and death.

Many boomers unknowingly contracted the virus in younger years from using drugs or having blood transfusions before screening was improved during the AIDS crisis. Unaware of the risk and without symptoms, most have never been tested for hepatitis C and don't know they have it. The disease — primarily contracted through blood — often remains hidden for decades while it slowly destroys liver cells. There is no vaccine.

"Hepatitis C is really a stealth virus," said Elizabeth Bancroft, medical epidemiologist with the Los Angeles County Department of Public Health. "It can live in you for many, many, many years."

There are at least 530,000 people living with hepatitis C in California, including an estimated 134,000 in Los Angeles County, according to health officials.

Harold Owens, who lives in Los Angeles and works at the Recording Academy, is among those paying the consequences for decisions made in his youth. He developed a heroin habit as a young man but says he hasn't touched drugs in nearly a quarter-century. He was diagnosed with hepatitis C in 2001. Now 59, he suspects he may have contracted the disease from sharing infected needles.

Owens underwent treatment that slowed the disease's progression but didn't expel it from his body. He still worries about what it could do to his liver. "It hangs over your head," he said.
"I understand the risks now," said Owens, who directs MusiCares, a foundation for musicians dealing with addiction. "I didn't then. Nobody did."

The Centers for Disease Control and Prevention plans to issue a recommendation this year that all baby boomers get tested. Those at risk include anyone who has used injection drugs, received a blood transfusion before 1992, are HIV positive or received a tattoo with non-sterile instruments.

More information about hepatitis C and where to find testing can be found on the California Department of Public Health website. 

The Motley Fool takes on universal testing for HCV...

Article posted on 3/16/12 on Motley Fool.com. The Motley Fool's Brian Orelli, Ph.D on the economics of universal testing for HCV. He makes the case that drug companies should leverage public policy to uncover as many potential patients as possible. What Dr. Orelli missed is that every HCV drug development company with skin in the game is already doing that through the Viral Hepatitis Action Coalition. A good read anyway.

Hep C Drugmakers' Best Outcome


By Brian Orelli, PhD

March 16, 2012

Treating hepatitis C is a losing proposition. Unlike treatments for chronic diseases -- high blood pressure or diabetes, for instance -- if a hepatitis C drug does its job, the patient is cured. It's a one-and-done treatment. Since the hepatitis C epidemic peaked many years ago, hepatitis C drugmakers need to find a new source of patients.

A report published in Clinical Infectious Diseases might have the solution: people who are already infected, but don't know it yet.

Current guidelines recommend testing only people who have identified risk factors such as drug use, blood transfusions before blood-bank testing began in 1992, or unexplained liver-function abnormalities, for example -- but that misses a substantial number of infected individuals. Estimates vary, but somewhere between 50% and 75% of people infected with hepatitis C don't know it.

Most probably have the risk factors, but they're unwilling to admit to the drug use, especially if it was years ago, or have forgotten about the blood infusion. Or the doctors aren't asking the right questions to identify the risk factors -- it's a touchy subject, you know.

The solution: Test everyone. You'll get a lot of negative results -- less than 2% of the population is infected -- but you'll catch those who might not have been diagnosed before they progress to serious liver problems.

The researchers plugged everything from costs to cure rates to likelihood of progression of liver disease and a lot of additional parameters into one giant formula and concluded that it would be cost-effective to screen everyone between the age of 20 and 69. Hepatitis C leads to liver cancer and other complications, and eliminating the cost of a liver transplant -- a quarter-of-a-million-dollar procedure -- can make up for a lot of $20 tests.

Sounds good, in theory

One journal article isn't going to change public policy; that will require a recommendation from the Centers for Disease Control and Prevention, which is a slow and methodical process.

If the CDC does institute universal testing for adults, hepatitis C test makers would certainly benefit. Just keep in mind that there's substantial competition out there: Abbott Labs (NYSE: ABT ) , Roche, Siemens, and OraSure Technologies (Nasdaq: OSUR ) all sell hepatitis C tests. They don't disclose margins on individual tests, but considering the number of players involved, I'd have to guess they aren't great.

Drugmakers developing hepatitis C treatments will be the real beneficiaries if more people are diagnosed. With the cost of treatment in the $80,000 range, each new patient is quite valuable.

That is, if they're treated
As the authors of the paper point out, screening is cost-effective -- and makes drugmakers money -- only if the patients who test positive are actually treated. Hepatitis C is a chronic infection that takes years to do any real damage in patients. Unlike cancer, where there's an immediate need for treatment, hepatitis C patients can take their time.

That could mean patients are lost to follow-up. It could also mean patients wait until drugs go off patent and there are cheap generics available before taking the drugs.

Identifying more patients is good, but they're not going to be moneymakers without the help of doctors.

Something companies can control
The cure rate of hepatitis C drugs is one of the factors that determine whether testing is worth the effort. If there were no way to treat patients, identifying infected patients would be only marginally useful.

As it is, Vertex Pharmaceuticals' (Nasdaq: VRTX ) Incivek has increased the standard of care substantially. Roche's Pegasys and Merck's (NYSE: MRK ) Pegintron cure about half of the patients, while adding Incivek increases that to around 70%.

As Gilead Sciences (Nasdaq: GILD ) , Abbott, and others develop better drugs, and we get closer to 100% cure rates, the benefit of testing will increase. It would be nice to have the patients waiting when the second-round of oral medications are approved, but drugmakers might have to get the drugs approved first and then show that identifying additional patients is beneficial.