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Roxanne Smith doesn't know how, when or where she contracted hepatitis C, but two new drugs are helping her fight the virus.




New drugs effectively wipe out hepatitis C

Roxanne Smith doesn't know how, when or where she contracted hepatitis C.

She just knows she now has a good chance of beating it.

"My hope is to kill the virus," the Lincoln woman said. "Kill it dead."

Although some hepatitis C patients in the past have used medications to permanently wipe the virus from their systems, two drugs approved this year by the Food and Drug Administration appear to do the job more successfully.

The drugs are extremely expensive — $25,000 to $50,000 for a course of treatment designed to eliminate the virus, in addition to about $30,000 for other drugs that are part of the treatment. They also have harsh side effects.

Nevertheless, doctors and patients have greeted the new drugs as potent weapons in the fight against a disease that can scar and ruin the liver.

"I think this is one of the biggest advances in medicine this year," said Dr. Marvin Bittner, a Creighton University and VA Medical Center infectious disease expert.

"It's a remarkable accomplishment, by all means," said Dr. Antonio Sanchez, a transplant hepatologist, or liver expert, at the University of Iowa Hospitals and Clinics. Sanchez said hepatitis C patients make up 40 percent to 50 percent of patients needing liver transplants.

The Food and Drug Administration approved both drugs in May.

Dr. Mark Mailliard, a University of Nebraska Medical Center hepatitis expert, said the old treatment strategy eradicated hepatitis C in about 40 percent of patients. The new strategy, based on clinical trials, appears to wipe it out in about 70 percent. Some patients with significant liver scarring or other medical problems aren't candidates for the new therapy.

Hepatitis C is a contagious liver disease that is generally spread by sharing needles or other equipment to inject drugs or medication. The federal Centers for Disease Control and Prevention says that before 1992, when widespread blood-supply screening began, hepatitis C also was commonly spread through blood transfusions.

The CDC estimates that 3.2 million Americans are chronically infected with hepatitis C. Some doctors believe it's much higher because, they say, the prison population and homeless people are undercounted and have high rates of the disease.

More than 800 new cases of the disease have been reported this year in Nebraska and more than 2,000 have been reported in Iowa, state health officials said. In most instances, the virus simmers in the system for years before seriously damaging the liver.

Many viruses, such as HIV and herpes, can only be suppressed and not cured, Mailliard said.

But hepatitis C can be wiped out entirely in some patients.

The new medications, which are in pill form, go by the brand names Incivek and Victrelis and also are known as telaprevir and boceprevir, respectively.

Until the new drugs came along, hepatitis C patients generally took a combination of interferon injections and a medication called ribavirin. That regimen, taken for many weeks, also had an array of side effects, including fatigue, irritability and rashes.

A patient receiving the newest regimen still takes those medications for weeks, plus either Incivek or Victrelis through a portion of that period.

"You take the tough treatment and you make it even tougher," Bittner said. "You take an expensive treatment and you make it even more expensive."

Mailliard, Bittner and others said the new therapy is generally worth the price and pain. Mailliard said he has prescribed the new drugs for about 90 patients and has seen excellent results based on blood tests during the course of therapy. The treatment may last a year, and patients must wait six months before testing reveals whether it has cured them. So it's too early to declare any of those patients cured.

Side effects of the new treatment regimen may include serious rashes, diarrhea, nausea and mouth sores, among others. Mailliard said that with the old regimen, five to 10 percent of patients weren't able to tolerate the effects. It appears that 15 to 20 percent won't be able to tolerate the new therapy, he said.

Most insurance covers the regimen, and both pharmaceutical companies that make the drugs provide financial assistance for those who need it. A spokeswoman for Vertex, which makes Incivek, said the company will provide the medication for free to an uninsured patient whose income is less than $100,000.

Medicaid in Iowa will cover both Incivek and Victrelis, while Nebraska Medicaid so far has asked doctors to use only Victrelis because it's less expensive. Mailliard said this is unfortunate because Incivek may be slightly more effective and the regimen is less complicated and thus easier for patients to understand and use.

Mark Crane, a 53-year-old Omahan, is undergoing the hepatitis C treatment through the VA Medical Center. The VA is covering it and so far, Incivek, interferon and ribavirin appear to be knocking the virus out of his system. Crane is about four months into his treatment.

He said his side effects have included fatigue, fever, nausea and insomnia, but he is pleased with the result.

"It seems to work," Crane said. "It's really good."

Roxanne Smith, whose insurance covers most of the cost, has continued to work as a flight attendant through the almost yearlong treatment period.

"I don't want the fear of it becoming a devastating treatment to keep people from trying," Smith, 57, said.

Smith has completed her Incivek therapy but is still taking interferon and ribavirin to complete the treatment. She had a bit of nausea and some sores in her mouth. She briefly had some weariness and shortness of breath.

"I think I'm one of the lucky ones," she said. "I know people that are in treatment right now that are having real side effects."

She sees this as her chance to push the virus from her system once and for all.

"I'm fighting it," she said of hepatitis C. "It's had me long enough."

Contact the writer: 402-444-1123, rick.ruggles@owh.com


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