Expand Screening, early treatment for Hep C.

NVHR Responds to New York Times Article on Hepatitis C Testing

July 22, 2010

Washington, DC-In response to today's New York Times article, "Hope against Hepatitis C," Andrew Muir, M.D., M.H.S., Director, Gastroenterology/Hepatology Research, Duke Clinical Research Institute and Steering Committee Member of the National Viral Hepatitis Roundtable (NHVR) 

released the following statement:

Washington, DC—

"Today's New York Times article details potential promising new drug therapies that could significantly improve the way we treat individuals infected with hepatitis C. Regrettably, the article suggests that expanded screening for hepatitis C may not be warranted. This approach is wrong and contrary to the direction in which we should and must move our health care system, particularly through improved access to care under health care reform. More than 5 million Americans are estimated to be infected with viral hepatitis B or C - and most are unaware they are infected as there are often few symptoms. Our health care system misses most infected individuals, who only learn that they have hepatitis C once they have progressed to liver cancer, cirrhosis, or liver failure. At that juncture, treatment options are limited and success rates are lower.

"Precisely because we do not know which individuals with hepatitis C will advance to these terrible diseases, it is critical that our public health infrastructure be modernized to achieve early detection of new infections and also to screen for individuals within specific risk groups, such as baby boomers and disproportionately affected populations. Once individuals are aware of their status, they will be empowered with this information, not only to make treatment choices, but also lifestyle choices to decrease their likelihood of disease progression and not to spread this infectious disease to others. In our current health care system, there are far too few options for diagnosis, care, and treatment. Unless or until the health care system provides access to all persons in need of hepatitis C treatment, it is important for the pharmaceutical industry to provide comprehensive compassionate care programs for those who are un/under insured.

"We can't prevent or treat what we don't know, which is why screening is critical. Access to screening would capture more infected individuals who can respond favorably to early intervention, reduce transmission, avoid needless medical expenses, and ultimately save thousands of lives annually."

NVHR is a coalition of more than 150 public, private, and voluntary organizations dedicated to reducing the incidence of infection, morbidity, and mortality from chronic viral hepatitis that afflicts more than 5 million Americans. www.nvhr.org

Contact: Phil Blando, pblando@abmpartnersllc.com, 202-534-1772

Hep C treatment: Time is of the essence.

Daily Checkup: Alcohol still risk, but viral hepatitis, fatty liver disease main causes of cirrhosis

BY Katie Charles

New York Daily News

Friday, July 16th 2010, 4:00 AM

As the chief of the division of liver diseases at Mount Sinai, Scott Friedman is a hepatologist who does research on how scar tissue forms in the liver.

Who’s at risk
“Fibrosis” is a term doctors use to describe the scarring of the liver that builds up over time as the result of liver damage. “Over many years, that scarring progresses and culminates in cirrhosis, which refers to an end-stage fibrosis,” says Friedman. “By then, the blood flow through the liver is impaired, and liver function may be compromised.”

A healthy liver has many vital functions, like detoxifying the blood, synthesizing critical proteins and hormones, fighting off infection and metabolizing sugars, fats and proteins.

Advanced fibrosis and cirrhosis are major public-health concerns that dramatically increase your chance of developing liver cancer.

“Liver cancer is the fastest-rising cancer in the U.S. and the third-leading cause of cancer mortality worldwide,” says Friedman. “The bulk of patients with cirrhosis in this country have it from hepatitis B or C − about 5.3 million Americans are living with chronic viral hepatitis.”

The second-leading cause of fibrosis is called “fatty liver disease,” in which fat accumulates in the liver and eventually leads to scarring. “Obese patients often overlook the risk of liver damage,” says Friedman. “Obesity often goes hand in hand with metabolic syndrome, which is associated with elevated blood lipids and blood pressure, insulin resistance and pro-thrombotic and an inflammatory state.” Fatty liver disease often improves after weight-loss regimens like bariatric surgery.

The underlying cause for fibrosis can also be alcohol abuse or rarer conditions like autoimmune diseases of the liver. “Alcohol abuse is definitely a risk factor, but the vast majority of patients with fibrosis and cirrhosis don’t abuse alcohol,” says Friedman. The old association linking cirrhosis solely with alcohol abuse no longer holds true now that viral hepatitis and fatty liver disease are the two primary causes of fibrosis and cirrhosis.

Signs and symptoms
One of the challenges of diagnosing and treating liver disease is that it most often develops stealthily.

“The liver is so resilient that it can compensate for years of disease, and the patient may have no symptoms until the disease is very progressed,” says Friedman. “In reality, many patients have advanced fibrosis but have no symptoms.”

The very late manifestation of symptoms means that it is even more important to identify if people are at risk and screen them to catch the disease early.

“People at high risk of liver disease include Asian immigrants, who are more prone to hepatitis B, and patients with evidence of metabolic syndrome, who are at high risk of fatty liver disease,” says Friedman. Other risk factors for hepatitis include people who got blood transfusions before 1990 and people who engage in high-risk behavior like needle-sharing. Alcohol abuse is still a risk factor, even if it is no longer the most common underlying cause.

New evidence shows that simple blood tests can do an excellent job of identifying a patient’s risk of liver disease. “We screen for ALT − alanine aminotransferase − an enzyme that enters the bloodstream if the liver is damaged,” says Friedman. “An elevated ALT level without explanation merits followup.”

Traditional treatment
“We have no treatments approved to attack the scarring in the liver yet,” says Friedman. “But we have some excellent treatments for the underlying diseases.”

There are effective medical therapies for hepatitis B and C. “For hepatitis B, the main drugs are molecules that block the multiplication of the virus,” says Friedman. “The hepatitis C treatments are a combination of the drugs interferon and an immunomodulatory drug called ribavarin, which together boost the immune system to fight the virus.”

New drugs that attack the hepatitis C virus directly are expected to be available next year. For patients with fatty liver disease, weight-loss regimens also reduce liver damage. “Anything from diet and exercise and medications to bariatric surgery can have great results,” says Friedman.

If alcohol abuse is the underlying cause, patients are usually required to enroll in a 12-step rehab program.

Once the liver disease progresses to the point of impairing liver function, doctors treat the resulting symptoms. “We try to treat all the liver problems and screen for liver cancer,” says Friedman. “For select patients, liver transplantation may be necessary.”

But doctors hope they can help more patients control their liver damage before it gets to that point. “There is now evidence that if we treat the underlying liver disease, even cirrhosis is reversible,” says Friedman.

Doctors are making liver disease an increasingly manageable illness through prevention, early detection and the treatment of fibrosis before it progresses too far.

Research breakthroughs

Some of the most exciting liver disease research is being done at the molecular level.

In 1985, Friedman identified the cell type that’s responsible for the formation of scarring tissue.

“Basically, we’ve gone from uncovering [what] causes scar formation to soon being able to treat and prevent fibrosis with medication,” says Friedman. “Our hope is that if we develop new treatments for fibrosis, we’ll be able to prevent the development of cirrhosis.”

Questions for your doctor

Hepatitis is a major public health risk, so be proactive about asking your doctor, “Am I at risk of hepatitis?”

Follow up with, “Should I be vaccinated for hepatitis A and B?” Another good question is, “Do I have any risk factors for liver disease?” and “Is my ALT elevated?”

What you can do

• Know your risk level.
  That means knowing the risk factors of liver disease — especially hepatitis and fatty liver disease — and knowing your ALT level. “If your ALT level is abnormal on even one reading, you should have it followed up,” says Dr. Scott Friedman. 

• Get informed.
  The American Liver Foundation has great patient information on support services and advocacy. See www.liverfoundation.org. 

• See a specialist.
  “If there’s evidence of chronic liver disease based on virus or blood tests, see a liver specialist,” says Friedman.

• Support liver disease research.
  “It’s a terribly underfunded research area,” says Friedman, who recommends giving to the American Association for the Study of Liver Disease at www.aasld.org.

Hep C risk and treatment for prisoners.

----------------From The HCV Advocate----------------

Hepatitis C Infection in Prisons

William Cassidy, M.D.
Louisiana State University-Health Science Center

Due to the epidemiology of hepatitis C (HCV), a higher percentage of inmates are HCV infected than in the general population. Depending on the prison system, 13 to 54% of inmates have hepatitis C. Recent Centers for Disease Control and Prevention (CDC) recommendations are that all incoming inmates be screened for HCV and those infected be evaluated for the presence of liver damage and the need for treatment.

This presents opportunities and challenges. Opportunities in that: 1) expensive treatment which requires close follow up is available for a group of people who quite likely would be uninsured if they were not incarcerated; 2) that those with a history of alcoholism and drug abuse are under enforced sobriety which may improve treatment outcomes; 3) and that these patients can be exposed to educational programs on how to decrease the risk of progressive liver disease and transmission of the infection.

The challenges are that: 1) prisons have restricted budgets and treating HCV is expensive; 2) the ability to address side effects of interferon may be limited because of the expense of hematologic growth factors, restrictions upon the use of sedatives and security issues inherent in the correctional setting.

Most prison systems are treating at least some HCV infected inmates. To standardize management, many prison systems have developed standardized protocols. Different systems take different approaches. Texas and Pennsylvania treat without performing liver biopsies. If a patient is infected, does not have a contraindication and desires treatment, he is treated. Other systems such as Louisiana, Georgia and the Federal Bureau of Corrections require a biopsy prior to treatment and only treat those with significant fibrosis. This approach is based upon the variability of the natural history of HCV.

To understand this approach, it is important to realize that when chronic HCV infection causes death, it does so by first causing cirrhosis (i.e., severe scarring of the liver). Technically, it is not HCV which causes death, it is the cirrhosis which HCV causes. This may seem to be splitting hairs but the importance of the distinction is apparent when it is realized that as many as 80% of HCV infected patients will not develop cirrhosis and therefore ultimately die with their infection but not die because of HCV. Ideally, therefore, those HCV infected patients treated first would be those at greatest risk of developing cirrhosis.

The question, then, is, are all HCV patients equally at risk for developing cirrhosis? The simple answer is no. Concomitant alcoholism, obesity, and hepatitis B or human immunodeficiency co-infections increase the risk for cirrhosis. Even if these factors are not present, some HCV patients will develop cirrhosis and some will not.

There are 3 major subgroups of HCV patients as regards risk for cirrhosis. These groups are called slow, intermediate and rapid fibrosers and are related to the amount of scarring in a patient’s liver biopsy compared to how long he or she has been infected.

The amount of scar tissue is quantified or “staged” on a scale of 0-4. Stage 0 is no scar tissue, stage 1 is minimal, stage 2 is moderate, stage 3 is moderate-to-severe and stage 4 is severe scarring of the liver. Stage 4 is also called cirrhosis.

Another term used is the “fibrosis index.” The fibrosis index is the stage of liver scarring divided by the number of years the patient has presumably been infected.

For example, if someone had a blood transfusion in 1968, and is diagnosed with HCV in 2003, it is presumed that they have been infected for 35 years. If they have a liver biopsy revealing stage 1 fibrosis, their Fibrosis Index is calculated as: stage 1/35 years or 0.029 stages of fibrosis per year infected. This suggests that it will take another 35 years to progress to stage 2. This person is clearly at low risk of developing cirrhosis. Since at this rate he will not develop cirrhosis for at least 70 years, even if cured of HCV, his life is not prolonged.

In another example, assume that the patient shared needles with a known HCV infected drug user 10 years prior to his liver biopsy. If the patient has stage 2 fibrosis now, his Fibrosis Index is 0.2 (stage 2/10 years = 0.2) suggesting that he will progress 2 stages every 10 years. This patient is at high risk for developing cirrhosis in most treatment protocols; treating him would be a priority.

These concepts of the variable progression of HCV and the Fibrosis Index apply to all HCV infected patients whether they are incarcerated or not. They are more important in correctional treatment protocols, however, due to the higher percentage of the inmate population who are HCV infected. The sheer numbers infected can overwhelm the resources available to treat infected inmates in even the most generous prison system. Using the Fibrosis Index allows triage of HCV infected inmates as to their relative risk of death from cirrhosis and prioritizing treatment to those at greatest risk.

If treatment is given, it may be with peg interferon, which is given once weekly, and ribavirin. For cost reasons, some systems are still using thrice weekly interferon and ribavirin. Most systems follow the National Institutes of Health Consensus Conference recommendations that therapy can be stopped at week 12 if there has not been either a 2 log decrease in HCV RNA relative to the baseline HCV RNA or a negative HCV RNA if the initial viral load was too low to fall 2 logs. Additionally, these treatment protocols stop treatment after 24 weeks for patients infected with genotypes 2 and 3.

In addition to treatment, the incarcerated HCV infected individual is ideally given information about reducing risk of disease progression and of infecting others. This includes information about abstaining from alcohol after discharge, avoidance of blood exposure and maintenance of ideal body weight. The CDC also has recently recommended that all HCV inmates be vaccinated for hepatitis A and B if not already protected.

The future of HCV management in prisons will see increasing standardization of protocols. Liver biopsies will be required by most for scientific and financial reasons and also because the Federal Bureau of Prisons’ recently published guidelines incorporates liver biopsy. Although the Federal Bureau does not dictate what states do, it is influential is establishing what the standard of care is.

There will hopefully be more research protocols made available for inmates to enroll in. Because of past abuses, it was made practically impossible to enroll inmates into drug treatment research protocols. This has been relaxed somewhat but is still extremely difficult and rarely done. Although these restrictions were originally instituted to protect inmates from exploitation, they now have the effect of denying access to cutting edge treatments. With the advent of informed consents, institutional research boards, prisoner advocacy groups and other entities, it is reasonable to assume that the past abuses could now be avoided.

In summary, HCV infection disproportionately affects inmates. Recent CDC recommendations are that incoming inmates be screened for infection and treated where indicated. This presents opportunities and challenges to the prison system. Understanding the natural history of HCV infection allows treatment to be focused upon those at highest risk of dying from HCV induced cirrhosis. The CDC also recommends education efforts directed towards minimizing disease progression and the infection of others with HCV. CDC also recommends HAV and HBV vaccination for HCV infected inmates.

Children should be seen, heard, and screened for Hep C.

Many Kids With Hepatitis C Are Missed

AZCentral.com
May. 2, 2010 11:00 PM
Health Day

SUNDAY, May 2 (HealthDay News) -- Many children with hepatitis C go undiagnosed and untreated, which can lead to severe liver damage later in life, a new study warns.

Researchers from the University of Miami Miller School of Medicine noted that national data shows that between 0.2 percent and 0.4 percent of children in the United States are infected with hepatitis C.

Based on that data, they thought they would find about 12,155 cases of pediatric infection in Florida, yet only 1,755 cases were identified, a mere 14.4 percent of the expected number of cases.

"Our study showed a lack of adequate identification of hepatitis C virus infection in children that could be widespread throughout the nation," said lead researcher Dr. Aymin Delgado-Borrego, a pediatric gastroenterologist and assistant professor of pediatrics.

Hepatitis C is like a "ticking bomb," she said. "It seems harmless until it explodes."

Most children and adults infected with hepatitis C do not have symptoms or only nonspecific symptoms, such as fatigue or abdominal pain, Delgado-Borrego said.

She planned to present the findings Sunday at the Digestive Disease Week conference in New Orleans.

Delgado-Borrego chose Florida for the study because it is one of the few states that requires all cases of the infection to be reported to the local health department

.

"Not only was there a lack of proper identification, but among the children that have been identified the percentage of those receiving medical care is extremely and unacceptably low," she said.

Based on these data, Delgado-Borrego's group found only about 1.2 percent of children with hepatitis C were receiving treatment by a pediatric hepatologist.

Most young children get the infection from their mothers while in the womb. That accounts for about 60 percent of the infections in young children, Delgado-Borrego said. Teenagers can get it through IV drug use and other substance abuse, she added.

So why are so many kids missed? According to Delgado-Borrego, there's a widespread lack of awareness of the condition and adequate screening is not often done. Moreover, children are too often not referred to treatment.

"Primary care doctors should screen all children who are at risk for hepatitis C infection, such as those whose mothers are infected," Delgado-Borrego said.

In addition, infected children should be referred to specialists, she added.

"Early identification of pediatric hepatitis C infection would likely help us cure the infection in over 50 percent of children that currently have it," Delgado-Borrego pointed out. "This would save children from liver damage as well as possible liver failure, liver cancer and even early death," she added.

Dr. Marc Siegel, an associate professor of medicine at New York University, said that, "this is a pretty shocking study."

Siegel said early diagnosis of hepatitis C is very important, especially in children. "Because if kids have it they have a lifetime of exposure to it, so the chances of damage to the liver is very high," he explained.

Hepatitis C is the leading cause of liver transplantation, Siegel noted.

More information
For more information on hepatitis C, visit the U.S. National Institutes of Health.