A new drug to treat people newly diagnosed with hepatitis C, a serious and sometimes deadly chronic liver ailment that infects nearly 4 million mostly unsuspecting Americans, was approved this week by the U.S. Food and Drug Administration and is available at the University of Rochester's Strong Memorial Hospital.
The treatment, Rebetron, is a combination of two antiviral drugs that is currently being used to treat patients who suffer a relapse of the disease, which can result in cirrhosis of the liver and even liver cancer. Hepatitis C is much more dangerous than other types of hepatitis, including Type A, which is sometimes spread by food handlers, and Type B, which is spread through contact with the blood of an infected person. Those patients typically recover within a few weeks.
FDA approval makes the medicine available to people who have just been diagnosed with hepatitis C and are beginning treatment. Up to now the combination was available to new patients only through research studies, including one at the University.
"The new treatment is truly a breakthrough for some patients who have suffered from the disease for decades with little relief," says Thomas Shaw-Stiffel, director of the University's Liver Service and a widely recognized liver expert who has been using the drug to treat some patients. "I have several patients who feel more energetic than they have in years - they're back out playing tennis or they've returned to jobs they had given up."
In recent studies physicians have shown that the new treatment is much more likely than today's standard treatment to kill off enough of the virus so that the level of virus in a person's blood becomes undetectable and relatively harmless, though it remains in the body and can intensify at any time.
Physicians estimate that about 4 million people in the United States are infected with the virus, but only about 5 percent know it. Many newly infected patients have no symptoms, while others simply feel like they're having a bout with the flu. Though patients may feel fine for years, the disease damages the liver over the course of the next 10 or 20 years. Most infections are related either to injected drug use or through blood transfusions before 1990, when suppliers began screening for the virus. Others at risk include health care workers or people who have had tatoos.
In the Rochester area alone, it's likely that about 20,000 individuals have hepatitis C, says Shaw-Stiffel. Nationwide about 10,000 people each year die of the disease. At least 20 percent of people with hepatitis C eventually develop liver cirrhosis, where the liver gradually hardens and fails to filter blood adequately. Hepatitis C is the leading cause of liver transplants in the nation today.
"It's a silent, insidious epidemic," says Shaw-Stiffel. "For many of these patients the infection is a result of exposure years ago, when they were much younger. Now they've got families, and they're worried about infecting their spouse or children."
A study recently published in the New England Journal of Medicine showed that Rebetron's combination of interferon injections and ribavirin capsules is more effective than the interferon injections that have been standard for people just beginning treatment. After a year with the new treatment, the combination reduced the virus to undetectable levels in 38 percent of patients, three times as many as in the group treated only with interferon. Viral levels remained undetectable for several months after the treatment was completed.
The results are even more remarkable for those suffering a relapse of the virus: The new treatment nearly eliminates the virus in half the patients treated, compared to just 5 percent of patients in relapse who receive interferon alone. Earlier this year the FDA approved Rebetron, made by Schering-Plough Corp., for the treatment of patients who have a relapse.
The drug combination itself is no picnic. Like treatment with interferon alone, Rebetron can cause depression as well as flu-like symptoms like headache, fatigue, and fever as it activates the body's immune system to fight off the virus. Nevertheless, few patients discontinue its use because it's so much more effective than the traditional treatment.