Treatment Has Limited Success: Side Effects Are Severe, the Cost High

Knight Ridder Newspapers

(KRT)

KANSAS CITY, Mo. - For many years the only treatments for hepatitis C worked so poorly that demand exploded when medications finally improved.

But even the newest treatments don't work much of the time. At best, a little over half the patients carefully selected for clinical trials respond to them - and the rate may be much lower in the general population.

In addition, side effects can still be so severe that some patients stop treatment or never begin.

Steve Bradford finished the new treatments last year, but the virus rebounded.

Despite the severe side effects from that treatment - "there were days I couldn't get off the couch" - the Kansas City, Mo., man said he won't give up. He wants to be around for his 11-year-old son.

In December, Bradford joined a clinical trial that doubles his medication - and he still battles the side effects.

Bradford is taking a combination of interferon and ribavirin, two anti-viral drugs. Drug companies recently "pegylated" the treatment, which keeps the medication in the body longer.

The treatment has a success rate of more than 50 percent, according to a federal conference last year on the disease. In some groups of patients, the treatment works even more often, according to clinical trials for Roche, one of the two drug companies that distribute it.

But in practice, such high rates are overly optimistic, a 2002 study showed, because only the patients most likely to benefit end up getting treated.

Doctors at a Cleveland hospital looked at 293 hepatitis C patients. They found that only 83 were treated, and the medication only worked in 11 of those persons.

"I think what our little study showed - and I think it represents the experience of most clinics - is that only about 20 or 30 percent of patients are going to be eligible for treatment," said one of the study's authors, Kevin D. Mullen.

Among the reasons patients weren't treated: failure to show up for doctor's appointments, problems with side effects, or other medical conditions such as psychiatric problems, pregnancy or diabetes.

Clinical trials, often funded by the pharmaceutical industry, end up giving doctors and patients alike a false sense of security, said Ting Lei, a medical anthropologist and behavioral scientist at the City University of New York.

"They are choosing the people most likely to have a positive outcome," he said.

Lei, who helps oversee clinical trials and human research at his university, said skewed results in studies mislead patients and downplay the serious problems with side effects.

A Schering-Plough spokesman agreed that only a fraction of hepatitis C patients get treatment, but said drug companies do nothing to create false hope about their medications.

Even when the treatment seems to work, the virus can come back in a more virulent form, said Jameson Forster, a liver transplant surgeon at University of Kansas Hospital. Hepatitis C comes in six different "genotypes."

The newest treatments also are no panacea for those desperate patients who did not respond to earlier medications. Only 15 percent to 20 percent of those "nonresponders" had encouraging results when re-treated.

Blacks face especially bleak prospects. Not only are a greater proportion of them infected, but they also respond poorly to treatment.

More than 3 percent of blacks carry the disease - twice the proportion as the white population. And the National Institutes of Health estimates that 6.1 percent of black people between 40 and 59 carry the virus.

Despite advances in treatment, side effects still include nausea, irritability, personality changes, depression and immune-system problems.

Recent studies have found that up to 14 percent of patients stopped taking the drugs because of side effects.

Tom Richards of Branson, Mo., said he had such bad side effects several years ago that he would "curl up in a fetal position and cry because it hurt so much." His doctor took him off the treatment when he attempted suicide, he said.

Last year, Richards started a new round of pegylated treatments but had to stop again because of the side effects. "I am lying in bed sweating and aching," he said before quitting.

Some patients end up paying a lot out of pocket for even a chance that a treatment may work on them.

The American Liver Foundation says it gets 250 calls a month from hepatitis C sufferers complaining about insurance reimbursement problems.

"It is critically important that all patients should have equal access to treatment regardless of the source of health-care coverage," according to a liver foundation statement last year to the National Institutes of Health Consensus Conference on hepatitis C.

Cost is a big part of the problem for insurance companies. One recent study showed that treatment can cost $25,000 or more a year.

Katie Brumble, who works at an accounting firm on Kansas City's Country Club Plaza, said her insurance carrier would only cover treatment for her hepatitis C under its major medical provisions, which pay about 80 percent of the cost.

As a result, she had to borrow more than $2,000 from her retirement account in 2001. The treatments didn't work - and she's still paying off the debt.

The 48-year-old Kansas City woman's new insurance company paid for almost all of her second round of treatments, which seems to have eliminated the virus.

Thomas Boyer, a Tucson, Ariz., liver specialist, said some companies use criteria based on old research on the disease.

"Getting treatments is a struggle," said Boyer, who is also past president of the American Association for the Study of Liver Diseases. "Some companies won't allow treatment of people with normal liver tests, and others won't pay for re-treatment of patients."

Uninsured patients have an even harder time.

"I had many patients who needed treatment and could not get the drug," said Joan Postow, a gastroenterologist who treated low-income patients at D.C. General Hospital, in Washington, D.C., until retiring in 2001.

Many hepatitis C patients who have not responded to current medications turn to alternative treatments, such as milk thistle, licorice, ginseng, garlic and dandelion.

But there may be new hope in drugs under development by Boehringer Ingelheim, a German pharmaceutical firm, and other companies. In early clinical trials, one "protease inhibitor," BILN 2061, caused a marked decrease of HCV levels in several patients. More research must be done, and side effects need further analysis, the company said.

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(c) 2003, The Kansas City Star. Distributed by Knight Ridder/Tribune News Service.