Hepatitis C, a silent killer, meets its match

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Determined to get rid of the hepatitis C infection that was slowly destroying his liver, Arthur Rubens tried one experimental treatment after another. None worked, and most brought side effects, like fever, insomnia, depression, anemia and a rash that "felt like your skin was on fire."

But this year, Mr. Rubens, a professor of management at Florida Gulf Coast University, entered a clinical trial testing a new pill against hepatitis C. Taking it was "a piece of cake." And after three months of treatment, the virus was cleared from his body at last.

"I had a birthday in September," Mr. Rubens, 63, said. "I told my wife I don't want anything. It would take away from the magnitude of this gift."

Medicine may be on the brink of an enormous public health achievement: turning the tide against hepatitis C, a silent plague that kills more Americans annually than AIDS and is the leading cause of liver transplants. If the effort succeeds, it will be an unusual conquest of a viral epidemic without using a vaccine.

"There is no doubt we are on the verge of wiping out hepatitis C," said Mitchell L. Shiffman, the director of the Bon Secours Liver Institute of Virginia and a consultant to many drug companies.

Over the next three years, starting within the next few weeks, new drugs are expected to come to market that will cure most patients with the virus, in some cases with a once-a-day pill taken for as little as eight weeks, and with only minimal side effects.

That would be a vast improvement over current therapies, which cure about 70 percent of newly treated patients but require six to 12 months of injections that can bring horrible side effects.

The latest research on the experimental drugs was presented at The Liver Meeting in Washington, which ends Tuesday.

But the new drugs are expected to cost from $60,000 to more than $100,000 for a course of treatment. Access could be a problem, particularly for the uninsured and in developing countries. Even if discounts or generic drugs are offered to poor countries, there are no international agencies or charities that buy hepatitis C medications, as there are for HIV and malaria drugs.

And some critics worry that the bill will be run up when huge numbers of people who would have done fine without them turn to the drugs. That is because many people infected with hepatitis C never suffer serious liver problems.

"The vast majority of patients who are infected with this virus never have any trouble," said Ronald Koretz, emeritus professor of clinical medicine at the University of California, Los Angeles.

But it is impossible to tell in advance whether an infected individual will go on to suffer serious consequences. For patients who can afford them, the temptation to take the new drugs before trouble arises will be powerful.

An estimated 3 million to 4 million Americans are infected with hepatitis C, and about 150 million worldwide -- three to five times the number who have HIV. Most people who are infected do not know it, because it can take decades for the virus to damage the liver sufficiently to cause symptoms.

In the U.S., the number of new infections has fallen to about 17,000 a year, from more than 200,000 per year in the 1980s, according to the Centers for Disease Control and Prevention. There has been a recent rise in cases among young people who inject pain medicines or heroin.

About 16,600 Americans had hepatitis C listed as a cause of death on death certificates in 2010, though that might vastly understate the mortality linked to the disease, according to the CDC. Although there are fewer new infections, the number of deaths is expected to keep rising as the infections incurred years ago increasingly take their toll.

Hepatitis C is spread mainly by the sharing of needles, though it can also be acquired during sex. The virus was transmitted through blood transfusions before testing of donated blood began in 1992. Mr. Rubens, the recently cured patient, believes he was infected when he worked as a paramedic long ago.

The main treatment has been interferon alfa, given in weekly injections for 24 or 48 weeks, combined with daily tablets of ribavirin. Neither drug was developed specifically to treat hepatitis C. The combination cures about half the patients, but the side effects -- flulike symptoms, anemia and depression -- can be brutal.

The new drugs, by contrast, are specifically designed to inhibit the enzymes the hepatitis C virus uses to replicate, the same approach used to control HIV. As with HIV, two or more hepatitis C drugs will be used together to prevent the virus from developing resistance.

To be sure, many of the new drug combinations have not been extensively tested yet. Side effects might still show up. And the drugs are not expected to work as well for patients with severe cirrhosis or those co-infected with HIV.

"I just don't think we know the answer until we get more widespread clinical experience," said Charles M. Rice, a hepatitis C expert at Rockefeller University. "We may be in for some surprises still."

These new drugs are likely to alter the calculus about who gets treated and when.


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