For decades, hepatitis C, a potentially fatal liver virus harbored by 3 million Americans, was a virtual black box.
Scientists knew there was some kind of nasty virus afoot in the land – and in the nation’s blood supply. In fact, they knew that one in five people who got a blood transfusion came down with infections caused by it. But they couldn’t find the virus itself. In fact, they didn’t even have a name for the disease it caused, dubbing it simply non-A, non-B hepatitis.
By 1988, they had found the virus and given it a name. By 1990, they had a detection test with which to screen blood donors. A year later, they had a treatment. By 1998, the number of new infections was cut by 80 percent and the risk of catching hepatitis C from donated blood was down to 1 in 100,000.
Today, treatments have progressed to the point where some people have not just experienced temporary remissions but may be cured.
Yet hepatitis C is still a huge threat. It has become the leading reason for liver transplantation. Granted, there’s now a two-drug regimen to treat it, but it makes many people feel worse than having the disease. The regimen, called Rebetron, has also generated fury among patients because of the controversial way the manufacturer, Schering-Plough, markets it.
Worse, many of the 3 million Americans who are infected with hepatitis C don’t even know it yet, because infection can smolder for years without causing symptoms. Eventually, more than 80 percent of people who come down with the virus end up with chronic infections. Of these, 20 percent go on to get cirrhosis, the destruction and scarring of liver tissue; of those, 20 percent develop liver cancer after 10 years and another 20 percent, end-stage liver disease.
Because so many people are infected and because of the long course of the disease itself, the death toll, now 10,000 a year, is likely to triple in coming years.
The first step toward combatting that, health officials say, is testing, especially for anyone who had a blood transfusion or organ transplant before 1992, when a new detection test made the blood supply safe. People who’ve used intravenous drugs are also at risk. Like the AIDS virus, hepatitis C is spread through blood contact, and, to a lesser extent than AIDS, through sex.
But luckily, testing just got easier. In the last few weeks, a $70 home test kit made by the Home Access Health Corp. began reaching stores. You prick your finger at home, put a few drops of blood on a piece of filter paper and mail it to the lab. You get the results, confidentially, in 10 days. You can also be tested at a doctor’s office or hospital, though the test is not part of a routine physical and may not be covered by insurance.
If the test comes back positive, you need more blood tests – for levels of enzymes that show whether you have liver damage. If you need it, your doctor will recommend a liver biopsy to see how much inflammation and cirrhosis (scarring) you have.
If the scarring is mild, some people postpone treatment on the grounds that the disease progresses slowly, and treatment with Rebetron, the “bundled” or pre-packaged combination of two drugs – interferon and ribavirin – can be long and miserable. Interferon causes intense flu-like symptoms such as fever, chills and joint aches; ribavirin can cause severe anemia.
Indeed, after discussion of the pros and cons, says Dr. Fredric Gordon, medical director of liver transplantation at Lahey Clinic Medical Center in Burlington, 25 percent of his patients decide not to be treated. For some, it’s “just too early” in the disease. Others “want to wait for better drugs.”
Many patients, however, do grit their teeth and go for it; among them, a 47-year old Malden man, who asked that his name not be used. He felt fine before treatment, he says, but now feels like he’s got the flu whenever he gives himself an injection of interferon. So far, he’s been taking Rebetron for four months now and has eight to go. But his liver tests already show improvement, and he’s determined to stick it out.
That makes sense, because while interferon alone yields a sustained response 10 percent of the time, interferon plus ribavirin can quadruple that. (A sustained response is defined as undetectable levels of virus six months after the end of treatment.)
“I tell patients that if by six months after treatment they’re free of the virus, there’s a 90 percent chance they’re cured,” says Dr. Sanjiv Chopra, director of clinical hepatology at Beth Israel Deaconess Medical Center.
But Rebetron, or more precisely, its manufacturer, Schering-Plough, nonetheless draws ire from many patients.
In June, 1998, the US Food and Drug Administration approved Rebetron as a bundled product. That means it’s sold – for $1,440 a month – as a package containing Schering’s interferon, called Intron A, plus ribavirin, an antiviral drug discovered by ICN Pharmaceuticals and now made by Schering.
The catch is that ribavirin is only FDA-approved as part of the Rebetron package. “Ribavirin by itself doesn’t work. The only thing that works is the combination. What’s not known is whether combinations [ of ribavirin] with other interferons work as well as with Schering’s,” says Dr. Bruce Bacon, a liver specialist at Saint Louis University in Missouri.
That irks patients who want to combine ribavirin with interferon made by other companies, notably Amgen and Roche Laboratories, in the hope, so far unproved, that the other interferons might be less toxic or more effective.
“It’s outrageous,” says Brian Klein, a founding member of HAAC, the Hepatitis C Action and Advocacy Coalition, based in San Francisco and New York. Not only does bundling prevent other researchers from testing their interferons with ribavirin, “the bundling hides the outrageously inflated cost of the little pills because you can’t buy them separately.”
Some patients resort, perfectly legally, to asking “compounding” pharmacies, notably Fisher’s Specialized Pharmacy Services in Pittsburgh, to convert bulk ribavirin powder into capsules for them, which they then take with other companies’ versions of interferon. Betty Stein, a pharmacist-owner at Fisher’s, says the pharmacy fills orders every day for hepatitis C patients and charges only $225 for a month’s supply.
Other patients, including a 25-year old Roxbury woman, have gotten ribavirin through patient-organized buyer’s clubs. “It’s a good thing I did, because Shering-Plough monopolized the drug,” says the woman, who used ribavirin with “consensus” interferon, a rival product to Schering’s that combines several components of interferon and which, she hopes, may have a “better track record.”
But Schering is “not going to unbundle” Rebetron, says company spokesman Bob Consalvo. Cost is not an issue because insurers usually pay, he says. And if patients are poor and have no insurance, the company provides the drugs free, he adds.
Recently, some patients have been adding other drugs to the regimen, notably a flu medicine called amantadine. According to research presented at a recent conference, Italian scientists found that by six months after treatment, 43 percent of patients on this triple-drug therapy had a sustained response versus 5 percent with two drugs.
Dr. Thomas Najarian, a Belmont internist, says he’s encouraged by such findings. So is one of his patients, William Bochicchio, 43, a contractor from W. Ossipee, N.H., who used the triple therapy for nine months. It was “pretty rough,” but he’s been virus-free for two years and says, “I’m cured.”
And there could be even better treatments in the near future, including “pegylated” interferon – interferon hooked to a chemical called polyethylene glycol. This compound would be injected just once a week. Now in clinical trials, pegylated interferon alone may be as effective as Rebetron, says Dr. Ray Chung, medical director of liver transplantation at Massachusetts General Hospital in Boston.
Also in the pipeline are protease and helicase inhibitors, which could combat replication of the virus directly. Anti-fibrotic drugs to reduce scar tissue in the liver may also help.
Some patients also take an herbal remedy called milk thistle, sold as a dietary supplement. This may improve scores on liver tests, but there’s no evidence it eradicates the virus.
The bottom line is that if you think you’re at risk, get tested. And if you test positive, at least take common-sense steps, like not exacerbating liver damage by drinking alcohol. And of course, talk with a doctor about what treatment, if any, to have.
“This is a pretty stubborn, insidious disease,” says Bochicchio, the New Hampshire contractor. “The virus eats away at your liver, slowly but surely.”
Living with hepatitis C
He’s only 31, still on the verge of a blossoming career as a DNA researcher at Harvard Medical School. But this biochemist, who for professional reasons asked that his name not be used, has been plagued his entire life with hepatitis C.
He was “an Rh baby,” he says, meaning that because of a blood abnormality, he was vulnerable as a fetus to a potentially fatal anemia caused by antibodies in his mother’s blood. Indeed, his mother had lost a previous baby this way.
So he was given transfusions while he was still in the womb – in the 1960s, before tests became available to monitor the blood supply. He often felt, growing up, that he was “getting older faster than I should have been,” but he still played softball, went skiing, hiking and studied. “I had no idea I was sick,” he says.
By the time he was diagnosed with hepatitis C – at 27 – his liver was severely scarred. By 28, he had liver failure. At 29, he had a liver transplant. (Hepatitis C is so prevalent, in fact, it is now the leading cause for liver transplantation.)
To prevent the virus, which still lingered in his body, from attacking the new liver, he underwent therapy with interferon and ribavirin for a year. That treatment, which causes intense flu-like symptoms, was “worse than the disease.. . .You get really depressed and hopeless,” he says.
But “it is something you can get through and I think treatment is worth it, even though it’s horrible,” he says. He urges anyone who may be at risk to get tested and treated.
After all, he’s now virus-free for the first time in his life. And that, he says, is “pretty cool.“