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.

Levels of Hepatitis C Virus Higher Among African-Americans and Males

Posted on 7/10/12 on www.amren.com. A collaborative study between the National Institutes of Health Clinical Center and UCSF to be published in the July issue of "Hepatology" showed that among IVDUs males and African Americans were more likely to have HCV and/or HIV than any other demographic. This has implications for treatment in that African Americans are less likely to respond to current therapy than any other demographic. 

Levels of Hepatitis C Virus Higher Among African-Americans and Males

Medical Xpress, July 10, 2012

Epidemiologists have determined that levels of hepatitis C virus (HCV) found among injection drug users (IDUs) were higher in individuals who are male or African American even after differences in other factors were considered. The study, which was funded by the National Cancer Institute and performed with collaborators from the National Institutes of Health Clinical Center and the University of California—San Francisco, was the first to simultaneously examine the association of demographic, viral and human genetic factors on HCV RNA levels. Results of the study published in the July issue of Hepatology, a journal of the American Association for the Study of Liver Diseases (AASLD), also showed higher levels of HCV among IDUs who were co-infected with human immunodeficiency virus (HIV).

A 2010 report from the Centers for Disease Control and Prevention (CDC) estimates that up to 3.9 million Americans have chronic HCV—a leading cause of liver cancer, end-stage liver disease and liver transplantation. According to the CDC 17,000 new cases and 2,800 acute cases of HCV were reported in 2010. Previous epidemiologic studies suggest one-third of those 18 to 30 year-old IDUs and up to 90% of older IDUs are infected with HCV.

“With such a high incidence and prevalence of hepatitis C virus infection among IDUs, it is important to understand the characteristics of the infection in this group,” explains lead author Dr. Thomas O’Brien of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute in Rockville, MD. “The HCV RNA level is an important predictor of response to treatment in patients with chronic hepatitis C. Our study is the first to examine simultaneously the viral, demographic, and genetic factors that impact HCV levels in ethnically diverse IDUs.”

Participants were originally recruited for the Urban Health Study—a multi-ethnic group of IDUs in San Francisco. Researchers used interview data and biological samples from participants to analyze demographic, viral and host characteristics of cancer-causing viruses. A total of 1701 participants had detectable HCV RNA and were included in the present study. The median age at enrollment was 46 years and median age of first illicit drug injection was 18 years. Close to 75% of participants were men and 56% were African American, 34% European (non-Hispanic) and 7% Latino (non-African American).

Adjusted analysis revealed that age, gender, racial ancestry, HIV-1 infection, and IL28B rs12979860 genotype were all independently associated with the HCV RNA level. “We know that the level of HCV is an important predictor of treatment response and that these levels seem to be influenced by a number of demographic, clinical, viral and human genetic factors,” concludes Dr. O’Brien.

CDC recognizes HCV deaths are up, ponders changing HCV screening guidelines...

Posted on 2/20/12 in the Wall Street Journal. The CDC muses updating their testing guidelines to recommend that anyone born between 1945 and 1965 get a one-time HCV screening based on recent data. This includes a Stanford University study that despite the hefty price tag that comes with HCV therapy, it would be cost-effective for people with advanced disease vs the cost associated with transplant or potentially dying from liver cancer. The study also concluded that gene testing, like the IL28B polymorphism assay, may be useful for those in the very early stages of disease to predict who could benefit from the less-expensive two drug regimen of PEG-inteferon + RBV vs the costly triple drug regimen of PEG-interferon + RBV + Protease Inhibitor. Sounds like a pragmatic approach to me. 

FEBRUARY 20, 2012, 5:01 P.M. ET.Hepatitis C deaths up, baby boomers most at risk .

Associated Press
WASHINGTON — Deaths from liver-destroying hepatitis C are on the rise, and new data shows baby boomers especially should take heed — they are most at risk.

Federal health officials are considering whether anyone born between 1945 and 1965 should get a one-time blood test to check if their livers harbor this ticking time bomb. The reason: Two-thirds of people with hepatitis C are in this age group, most unaware that a virus that takes a few decades to do its damage has festered since their younger days.

The issue has taken new urgency since two drugs hit the market last summer that promise to cure many more people than ever was possible. And research published Monday says testing millions of the middle-aged to find those who need the pricey treatment would be worth the cost, saving thousands of lives.

"One of every 33 baby boomers are living with hepatitis C infection," says Dr. John Ward, hepatitis chief at the Centers for Disease Control and Prevention. "Most people will be surprised, because it's a silent epidemic."

Don't think you need to worry? Yes, sharing a needle while injecting illegal drugs is the biggest risk factor for becoming infected with this blood-borne virus. But before 1992, when widespread testing of the blood supply began, hepatitis C commonly was spread through blood transfusions. Plus, a one-time experiment with drugs way back in high school or college could have been enough.

"Asking someone about a risk that happened 20 to 30 years ago is a lot to ask," says Ward. Hence the quest for a new strategy.

About 3.2 million Americans are estimated to have chronic hepatitis C, but at least half of them may not know it. The virus, which affects 170 million people worldwide, can gradually scar the liver and lead to cirrhosis or liver cancer. It is a leading cause of liver transplants.

A CDC study published Monday analyzed a decade of death records and found an increase in death rates from hepatitis C. In fact, in 2007 there were 15,000 deaths related to hepatitis C, higher than previous estimates — and surpassing the nearly 13,000 deaths caused by the better-known AIDS virus.

Perhaps more surprising, three-fourths of the hepatitis deaths occurred in the middle-aged, people 45 to 64, researchers reported in Annals of Internal Medicine.

"Mortality will continue to grow for the next 10 to 15 years at least unless we do something different" to find and treat the silent sufferers, Ward says.

CDC's current guidelines recommend testing people known to be at high risk, and until last summer there wasn't much enthusiasm even for that step: the reasons are the year-long, two-drug treatment promised to cure only 40 percent of people; treatment was so grueling that many patients refused to try it and treatment could cost up to $30,000.

Two new drugs — Vertex Pharmaceuticals' telaprevir and Merck & Co.'s boceprevir — are starting to change that pessimism. Research suggests adding one of them to standard therapy can boost cure rates as high as 75 percent. While still full of side effects, they can allow some people to finish treatment in just six months. They add to the price, however, another $1,000 to $4,000 a week. Drugs that promise to work even better have begun testing.

Those advances are fueling CDC deliberations of whether to change testing guidelines to recommend that anyone born between 1945 and 1965 get a one-time screening. A second CDC-funded study published Monday analyzed models of that option, and concluded it had the potential to save 82,000 lives.

A third study published Monday from Stanford University looked more closely at the price tag, and concluded the new triple-therapy would be cost-effective for people with advanced disease. It's still cheaper than a transplant costing well over $100,000. But not everyone with hepatitis C will go on to suffer serious liver damage. For those with mild disease, that analysis concluded some gene testing to predict who might really need the costlier triple therapy rather than the older drugs would be a good next step.

It's not clear how quickly the CDC will settle the boomer-screening question. But doctors at New York's Montefiore Medical Center have started raising the issue with boomers. And Montefiore internist Dr. Gary Rogg says a number of patients have sought testing after seeing hepatitis-awareness ads from the drugs' manufacturers.

"Now it's considered a curable disease, that makes all the difference," says Rogg, who was surprised at some longtime patients' test results. Even a nurse he knows learned she had it, and the only risk she could recall was a blood transfusion during surgery when she was 10 years old.

___

EDITOR's NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

___

Online: Centers for Disease Control and Prevention: http://www.cdc.gov/

Montefiore Medical Center: http://bit.ly/u6scH0

HCV leaps ahead of HIV as leader of cause of death in the U.S.

From POZ.com. HCV surpasses HIV as a leading cause of death in the US, according to the CDC

November 10, 2011

Hepatitis C Surpasses HIV as Cause of Death in U.S.

It’s official. Chronic hepatitis C virus (HCV) infection is associated with more deaths than HIV infection, according to sobering new data presented by the U.S. Centers for Disease Control and Prevention (CDC) on Tuesday, November 8, at the 62nd annual meeting of the American Association for the Studies of Liver Diseases (AASLD) in San Francisco.

The discouraging findings, presented by Scott Holmberg, MD, MPH, chief of the CDC’s Division of Viral Hepatitis Epidemiology and Surveillance Branch, come from data involving 21.8 million deaths reported to the National Center for Health Statistics between 1999 and 2007. The only cases included in the analysis involved reports that specified HIV, AIDS, HCV or hepatitis B virus (HBV) infection as possible contributors to the deaths.

Encouragingly, death rates associated with chronic HBV infection—a major cause of liver failure and liver cancer—remained relatively flat between 1999 and 2007. In 2007, for example, about 1,800 U.S. residents died of HBV-related complications, which translated into less than one chronic hepatitis B-attributable death per 100,000 people in this country.

Death rates related to HIV infection continue to fall. Whereas HIV contributed to 6 per 100,000 deaths in 1999, the rate dropped to less than four per 100,000 deaths in 2007.

Hepatitis C–related deaths have increased sharply, Holmberg’s team reported. Whereas HCV contributed to roughly 3 per 100,000 deaths in 1999, the HCV-related death rate exceeded 4 per 100,000 people in the United States by 2007.

With respect to crude numbers, roughly 12,700 HIV-related deaths were reported to the National Center for Health Statistics in 2007. More than 15,000 HCV-related deaths were reported to the center that year.

Most viral hepatitis deaths occurred in people in the prime of their lives. About 59 percent of people who died of complications related to hepatitis B were between the ages of 45 and 64. The impact of chronic hepatitis C was even more substantial—roughly 73 percent of the deaths related to HCV were in baby boomers.

Not surprisingly, death rates were highest among certain populations. For example, people coinfected with both HBV and HCV faced a 30-fold increase in the risk of death from liver disease or related complications. Alcohol abuse was associated with a four-fold increase in the risk of death. Coinfection with HIV nearly doubled the risk of death from HBV-related complications and quadrupled the risk of death from HCV-associated liver disease.

“[Achieving] declines in mortality similar to those seen with HIV,” Holmberg’s group concluded, “will require new policy directions and commitment to detect and link infectious persons to care and successful treatment.”

NPR's "Talk of the Nation" interviews Dr. John Ward, Director, Division of Viral Hepatitis, Centers for Disease Control and Prevention.

You can link to the transcript, streaming audio or podcast formats here.

Interesting interview, both available in transcript, streaming and podcast form. Dr. Ward's statement that "not every person living with hepatitis C needs to be treated for hepatitis C, and it really has to be based on the progression of their disease and the timing of that therapy" in the context of the adverse events and costs of the new DAAs is sure be a topic of conversation both within the drug development industry and the HCV provider/patient community.

Xconomy Biotech Editor Luke Timmerman on Vertex's push for CDC to increase HCV testing...

Seems like Luke gets the big picture and that's good. There is a ton of HCV out there, the current standard of care only works 40% of the time, and the costs associated with the burden of disease will be astronomical, with the majority of the cost falling on government payors. The details that need to be ironed out include questions such as what is to be done with patients who fail DAA therapy with the hopes of adequate sequential therapy still 2-3 years down the road? What does HCV resistance mean and is re-treatment a possibility? What are the implications of drug interactions? With the DAAs being such a 'high touch' drug, what are the economic incentives for a provider to treat given that current reimbursement rates are so low? What are the costs associated with patient non-adherence? What are the pros and cons for-profit corporations having a say in shaping public policy? No doubt the DAAs will represent a groundbreaking therapy for HCV, but with only 4-5 months before their potential launch, there are still many unanswered questions.

Vertex Urges CDC to Recommend Hep C Screening, To Nudge “Second Tsunami” of Patients
Luke Timmerman 2/2/11

If Vertex Pharmaceuticals gets its way in talks with U.S. public health officials, most people over 50 could soon get blood tests to screen for hepatitis C infections at the doctor’s office. If the U.S. Centers for Disease Control and Prevention (CDC) agrees this is a good idea, it could prompt another 1 million patients who don’t realize they are infected to come out of the woodwork and start clamoring for Vertex’s new hepatitis C drug over the next few years.

The Cambridge, MA-based biotech company (NASDAQ: VRTX), which has operations in San Diego, has joined other drugmakers in supporting studies they hope will persuade the CDC to recommend routine screening for hepatitis C, Vertex CEO Matt Emmens said in a recent interview. The company is one of the sponsors of what’s called the Viral Hepatitis Action Coalition, a public-private partnership with the CDC, which is conducting studies known as BEST-C. These studies could determine how effective it is to screen patients for hepatitis C infection more widely.

These studies, which are expected to cost a total of $3.6 million, could be worth billions to Vertex if they show that screening random Baby Boomers is worthwhile.

An estimated 600,000 patients in the U.S. are expected to seek treatment that could include Vertex’s drug, or a rival offering from Merck, if the FDA clears the new drugs for sale as analysts expect in the middle of this year. The two new protease inhibitors are being hailed as major steps forward, as they have been shown to roughly double cure rates of hepatitis C, a viral infection that damages the liver over many years. Vertex’s drug, telaprevir, has shown it can push the cure rate up as high as about 75 percent, while cutting the treatment time in half to about six months. That means patients don’t have to endure such a long period of flu-like symptoms, which has traditionally discouraged many patients from getting treatment.

The new advance from Vertex, demonstrated in a trio of pivotal clinical trials, has created this huge wave of pent-up demand from patients and doctors. Knowing this, many analysts have projected the product will be pretty much an instant hit, topping $2 billion in U.S. sales after just a couple years. But then, some expect sales to taper off, as many of the most motivated patients get cured, and don’t need the drug anymore. Essentially, they see Vertex possibly becoming a victim of its own success.

That’s not how it will play out, says Emmens, a marketing veteran who spent much of his career at Merck. An estimated 3.2 million to 3.9 million people in the U.S. have chronic hepatitis C infections. That’s a lot more than the initial wave of patients, which is mostly composed of people who sought treatment before but relapsed. Besides those patients, many more candidates are Baby Boomers who don’t know they contracted the hepatitis C infection decades ago through unprotected sex, IV drug use, or blood transfusions from contaminated supplies. Many of these infections lie dormant for about 20 years or more, but are just now starting to emerge over the decade to come, Emmens says. Some patients won’t see symptoms at all, and as the AP pointed out in this solid feature last month, it’s hard to tell which infected patients are likely to get the worst symptoms. The unluckiest ones will end up suffering severe liver scarring (cirrhosis), liver cancer, liver transplants, and ultimately, premature death.

Connecting with that massive crowd of patients, who aren’t motivated to seek treatment today because they don’t see any really bad symptoms yet, is one of the big marketing challenges Vertex faces. The company is planning to spend some of its $1.3 billion cash hoard on a public awareness campaign designed to urge people to get tested to see if they have the virus, Emmens says. But even more important than the ad campaign, Vertex is hoping the CDC will recommend routine hepatitis C screening, which would start turning up a lot more positive tests. If it does, Emmens he predicts it could prompt another 1 million patients to seek treat treatment around 2014 and later, right as the most people in the initial wave of highly motivated patients go home having been cured.

“You have an estimated 2 million people out there who are not aware they are infected,” Emmens says. “Some don’t know, or just don’t give a damn, or have other problems, and won’t seek treatment. But if you found 1 million new patients over a two or three-year period, there’s a second tsunami.”

As for analysts predicting telaprevir will rise and fall, Emmens shook his head. “That’s absurd. I understand they’ve got to do their job. But from a marketing guy’s perspective, that just doesn’t happen unless you lose your patent,” Emmens says. “Docs use what works. Patients will come in, and they will want the highest chance they can get of a cure. That’s what they really care about.” A shorter treatment period, and more convenient twice-daily dosing instead of thrice-daily are a couple of other features Vertex is hoping to incorporate into hepatitis C treatment, he adds.

Vertex has clearly been spending a lot of time lately thinking about making its case to insurers. The trick will be to persuade insurers that it’s worth spending quite a bit of money upfront on a potent new drug to attack a dormant infection, as opposed to waiting to see if patients get sick years later and rack up big hospital bills. Emmens notes that liver transplants cost around $300,000, and, obviously, not everyone who wants a new liver actually survives long enough to get to the top of the waiting list. Vertex, citing an actuarial study it sponsored to try to measure the cost of future treatment, says medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion—presumably when factoring in a lot of liver transplants.

I must say I’m personally wary of drugmakers who use their money and influence to rewrite health guidelines that end up favoring their bottom line. Companies that want to sell more drugs for high blood pressure, osteoporosis, and obesity have been known to push for new health guidelines that classify many more people as “Suddenly Sick” as a couple of my former Seattle Times colleagues wrote in a terrific investigative story in 2005. Whether this aggressive new treatment is really beneficial to people’s health over the long run is often unknown.

This case strikes me as somewhat different, though, because today’s available hepatitis C treatment is really so poor. Vertex and Merck are essentially coming along with drugs that represent a big leap ahead with potential to cure hundreds of thousands, maybe millions, of people. It will probably cost taxpayers a few billion dollars a year for many years to come, and it’s always hard to say for sure how many billions you might save down the road when people don’t end up in the hospital getting liver transplants. But you can be sure Vertex is working hard behind the scenes right now to convince officials that an ounce of prevention is worth a pound of cure.

Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle. You can e-mail him at ltimmerman@xconomy.com, or follow him at twitter.com/ldtimmerman.

Original article: http://www.xconomy.com/boston/2011/02/02/vertex-urges-cdc-to-recommend-hep-c-screening-to-nudge-second-tsunami-of-patients/