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Experimental Drug for Hepatitis C Promising, Studies Show
Date:4/23/2013

By Steven Reinberg
HealthDay Reporter

TUESDAY, April 23 (HealthDay News) -- A new treatment for difficult-to-treat hepatitis C has higher cure rates, takes less time and causes fewer side effects than the current therapy, new research finds.

When the new drug, sofosbuvir, is combined with the medication ribavirin, cure rates are as high as traditional therapy, which pairs ribavirin and pegylated interferon, the researchers say. But patients taking sofosbuvir -- a once-a-day pill -- are spared the severe side effects associated with interferon.

"This is an exciting time in which we are witnessing a fundamental paradigm shift in the way we treat hepatitis C," said researcher Dr. Ira Jacobson, chief of the division of gastroenterology and hepatology at the Weill Cornell Medical College in New York City.

Many people with hepatitis C can't or won't use interferon, Jacobson said. Its side effects can include sleep problems, anxiety, irritability and depression as well as fatigue, headaches, fever and muscle aches.

Hepatitis C is a virus spread by infected blood during transfusions, injection drug use or sexual contact. Untreated hepatitis C can cause progressive liver disease, such as cirrhosis, liver cancer and liver failure.

In one of two new studies involving sofosbuvir, researchers treated patients who hadn't responded to interferon treatment or couldn't take it because of other medical conditions.

Among patients for whom interferon was not an option, three months of the ribavirin-sofosbuvir combo resulted in a 78 percent cure rate.

For those who had not responded to interferon, 73 percent were cured after four months' treatment with ribavirin and sofosbuvir, the researchers found.

Side effects from sofosbuvir were generally mild and included fatigue, nausea, headache, insomnia, itching, anemia and dizziness.

Dr. David Bernstein, chief of the division of hepatology at North Shore University Hospital in Manhasset, N.Y., voiced enthusiasm for the new treatment. "I think this is a tremendous advance in our treatment for hepatitis C," said Bernstein.

Standard treatment with interferon can last for 48 weeks, he said.

Sofosbuvir is now in the final phase of U.S. Food and Drug Administration trials. Bernstein said that, if approved, it should become the standard of care.

The results were published online April 23 in the New England Journal of Medicine. They are also scheduled for presentation Friday at a meeting of the European Association for the Study of the Liver in Amsterdam, the Netherlands.

In another study, researchers evaluated previously untreated patients with hepatitis C, either the subtype known as genotype 2 or the harder-to-treat genotype 3.

Patients were randomly assigned to receive either sofosbuvir and ribavirin for 12 weeks or ribavirin and interferon for 24 weeks. The cure rates were similar for both therapies: 67 percent.

The trials were funded by Gilead Sciences, maker of sofosbuvir. The company wouldn't comment on sofosbuvir's potential cost prior to its approval. Jacobson consults and lectures on behalf of Gilead Sciences.

Given sofosbuvir's proven benefit, these therapies can have a significant health-care impact that should save lives, said study co-author Dr. David Nelson.

"Potent direct-acting antiviral agents will allow high cure rates without the need for interferon, which should expand treatment options to the majority of hepatitis C-infected patients," said Nelson, a professor of medicine and associate dean of clinical research at the University of Florida in Gainesville.

"With these well-tolerated treatment regimens and high cures rates, the focus now needs to shift to finding the millions of undiagnosed hepatitis C patients and assuring access to care," Nelson said.

Some 170 million people worldwide are infected with hepatitis C, and 350,000 die each year from the disease. In the United States, about 4 million people are infected, according to the U.S. Centers for Disease Control and Prevention (CDC).

Because many people don't know they have hepatitis C, the CDC recommends that all baby boomers be tested for the virus.

Hepatitis C is the leading cause of liver transplants in the United States, Bernstein noted.

More information

For more information on hepatitis C, visit the U.S. National Library of Medicine.

SOURCES: Ira Jacobson, M.D., chief, division of gastroenterology and hepatology, Weill Cornell Medical College, New York City; David Nelson, M.D., professor of medicine and associate dean, clinical research, University of Florida, Gainesville; David Bernstein, M.D., chief, division of hepatology, North Shore University Hospital, Manhasset, N.Y.; April 23, 2013, New England Journal of Medicine, online; presentation, European Association for the Study of the Liver, Amsterdam, the Netherlands, April 24-28, 2013


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