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Health, Science, Environment

Doctors, researchers confront a silent disease: Hepatitis C

This article first appeared in the St. Louis Beacon, Feb. 4, 2009 - An unmistakable shroud of silence surrounds Hepatitis C, a viral liver disease that can lead to permanent liver damage, liver cancer, transplants and death.

There’s the silence of diagnosis. A patient could have had Hepatitis C for as long 20 years without being diagnosed. The disease can produce mild symptoms that are ignored by the patients or missed by their physicians.

“Primary care doctors don’t have a great amount of knowledge about Hepatitis C,” said Dr. Adrian Di Bisceglie, professor of internal medicine and chief of hepatology at the Saint Louis University School of Medicine. “We see the whole spectrum [of patients]. Hepatitis C can be mild after 10 to 20 years or it can be severe after 5 to 10 years.”

The symptoms can include fever and fatigue, loss of appetite, joint pain, nausea and vomiting. The only way to confirm a diagnosis is a blood test.

“The typical patient is someone in his or her 40s or 50s who recently found out,” said Dr. Bruce R. Bacon, director of gastroenterology and hepatology at the medical school.

The large group of middle-age patients reflects the changes in testing and prevention over the years, especially since Hepatitis C screening started in 1992 for blood transfusions. During the 1980s, the Centers for Disease Control and Prevention estimates there were an average of 230,000 U.S. new cases annually. By 1996, the new cases per year had dropped to 36,000. By 2006, according to the latest available data, CDC estimates 19,000 new cases per year although the number of reported cases was much lower.

Overcoming Fear

There’s a silence after the disease is diagnosed. Some patients decline treatment because they have read or heard about the potentially rough side effects from medications that can treat or cure the disease.

“The treatment is not the enemy - the disease is the enemy,” Dr. Bacon said. Dr. Di Bisceglie added: “A majority of the people we see are anxious about the disease or the treatment. What they read on the Internet scares them.”

And there’s the silence of many patients, too, because the disease is often linked to sharing needles, illegal drug use and, to a lesser extent, unsafe sex practices.

“I call it a silent epidemic because many people are ashamed and embarrassed,” said Katherine Bryson, who contracted the disease as a hospital nurse, apparently when she tended to violent substance abusers at the adolescent behavioral health unit of St. Anthony’s Medical Center.

She was diagnosed in October 2003, about nine years after she suspects she got infected by a combative patient.

Bryson got a blood test after she had opened a drawer, reached in to grab a syringe and was accidentally stuck by an exposed needle of a clean syringe. “I got a call on Halloween,” she recalled. “They said, ‘Kathy, how long have you had Hepatitis C?’ Prior to the test, she says felt fine other than being a little tired.

Two months later, a liver biopsy revealed liver cancer. Bryson cannot take Hepatitis C drugs due to the damage caused by the disease and because she has received chemotherapy for the cancer. Taking the powerful Hepatitis C medications could cause a heart attack.

Forced to retire after 28 years as a nurse, Bryson tried to drum up support for a state law requiring health care employers to provide voluntary Hepatitis C testing for employees. In 2006, former Gov. Matt Blunt signed into law a Hepatitis C Awareness Day on May 10, Bryson’s birthday. “We got something,” she said. “That’s the best we could do.”

Bryson, who lives in south St. Louis County, continues to educate people about the disease. “I talk to high school kids. I talk to police auxiliaries,” she said. Bryson noted that she has met nurses who won’t get tested because they fear they will lose their jobs. “There’s no reason to die from it.”

An Enigmatic Disease

Chronic Hepatitis C affects about 3.2 million Americans, says the Centers for Disease Control and Prevention. It kills 8,000 to 10,000 Americans each year. (The National Institutes of Health, citing “health experts,” says the worldwide toll is 180 million people with chronic Hepatitis C).

The CDC estimates the death rate at 1 percent to 5 percent. Public health experts believe the annual death rate will grow because there’s a growing percentage of patients who have had the disease for a longer time.

An estimated 15 to 25 percent of patients “will clear the virus from their bodies without treatment and will not develop chronic infection,” the CDC added. “Experts do not fully understand why this happens for some people.” There’s no vaccine to prevent the disease. The most effective prevention is lifestyle vigilance.

Aside from avoiding illegal drug use and unsafe sex, medical experts say people shouldn’t share personal care items, such as razor blades, that contain blood. Be wary of getting tattoos and body piercing: “You might get infected if the tools have someone else's blood on them or if the artist or piercer does not follow good health practices,” said the National Institutes of Health.

The standard course of treatment involves two drugs -- weekly injections of pegylated interferon and twice-daily doses of the antiviral pill known generically as ribavirin. One drawback to ribavirin is anemia, which merits a “black box warning,” the strong FDA alert. The FDA also says people with a history of unstable or significant heart disease should not take the drug.

Ribavirin appears to prevent the Hepatitis C virus from reproducing. However, ribavirin alone doesn’t effectively reduce the Hepatitis C virus levels in the blood; the FDA says it shouldn’t be used as a single therapy.

In the fight against Hepatitis C, interferon does the heavy lifting. The genetically engineered drug is derived from naturally occurring proteins produced by the body to defend against viruses, bacteria and other invaders.

Initially, doctors tried interferon alone until researchers discovered that the interferon-ribavirin therapy worked best.

The earliest interferon, approved by the Food and Drug Administration in 1991, has been superseded by pegylated interferon, which the agency approved earlier in this decade. PEG-interferon incorporates polyethylene glycol, enabling the drug to remain in the body longer. PEG-interferon requires fewer injections than the original interferon.

However, the side-effects remain. The drug label’s black box warning discusses the risk of psychiatric disorders, heart disease and immune system disorders. Other side effects include fever, flu-like symptoms, infections, high blood pressure and vision problems. These drugs also have limits to their effectiveness; they don’t work for everyone. The FDA hasn’t approved a new Hepatitis C drug in more than six years.

Big R&d Efforts

Companies continue pouring money into research, primarily for compounds that act differently than PEG-interferon or ribavirin. Five drugs are in late-stage clinical testing, says Sagient Research Systems, a San Diego-based firm that analyzes biotechnology developments. Under a best-case scenario, some drugs could be approved by the FDA between 2010 and 2012. Another 41 drugs are in other phases of clinical testing.

It’s a lot of R&D, but Sagient Research points out that this field is filled with disappointment. Since 2003, nearly two dozen compounds have failed in clinical trials. “Some drugs look promising but unexpected side effects emerge,” Dr. Di Bisceglie said.

The first batch of new drugs, called protease inhibitors, will have to be used with the existing medical cocktail to be effective. Research shows that when these compounds are used by themselves against HCV, the virus develops resistance quickly, Dr. Di Bisceglie said. (Both Dr. Bisceglie and Dr. Bacon have participated in clinical trials for experimental compounds. Both have received consulting fees and speakers’ fees for several companies working on new HCV drugs.)

And if defeating HCV were difficult enough, the virus has six major genetic variations, or genotypes, as well as dozens of subtypes.

About 70 percent of U.S. patients are infected with genotype-1, and most of the rest are infected with genotypes 2 and 3. The other genotypes are rare in the U.S. but are more common in parts of Southeast Asia and parts of Africa.

Dr. Bacon says studies show existing drugs can treat about 63 percent of genotype-1 cases as long as patients complete the medication regimen. If they stop the treatment, the success rate falls to 40 percent. For genotype-2 and genotype-3, studies show the treatment rate can be 80 percent to 90 percent if the patients stay with the drugs, he adds.

The typical treatment for genotypes 2 and 3 requires 24 weeks of PEG-interferon and ribavirin. For genotype-1, patients require 48 weeks of the drug combination.

Because HCV treatments are expensive and because they don’t work for everyone, Saint Louis University researcher John Tavis is working on a test that would help doctors determine if the treatment is succeeding.

Tavis and fellow SLU researchers published their results recently in The Journal of Clinical Investigation identifying mathematical patterns in the genetic structures of HCV patients. Comparing patients who responded well the HCV drug therapy versus those who did not, they devised a formula for predicting responses.

“We’re basically one large experiment away from knowing if our work has clinical utility,” said Tavis, professor of molecular and microbiology.

This experiment requires access to a huge data bank of genetic information about HCV “that doesn’t exist,” he said.

However, Tavis is talking to two entities that have access to the data or have the ability to generate the data.

Needless to say, he’s not identifying them and he’s not offering a timetable for securing an agreement or developing a test. “It would be like trying to carve something in Jello,” he said.

Tavis needs data based on stored blood samples; and the data must be sufficiently large so that the results aren’t subject to chance. If the experiment succeeds, the researchers could prepare a prototype HCV test; but the university would have to find a commercial partner to develop and market the test.

The test would focus primarily on Genotype-1 patients and would relate to the treatment of PEG-interferon plus ribavirin. It could be adapted to incorporate new types of HCV treatments.

“The test will tell you the relative sensitivity to the interferon arm of the treatment -- how long to treat, what type of dosage, how much interferon you will need,” he said.

Tavis says a course of HCV therapy could cost as much as $30,000 but a test could cost as little as $100.

Robert W. Steyer is a freelance business journalist living in New York.

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