April 30, 2009

Drug Could Cut Hepatitis C Infections In Half

Researchers have reported success with the addition of the anti-viral drug telaprevir to standard treatment of hepatitis C.

A team of researchers at the Duke Clinical Research Institute (DCRI) found that the duration of hepatitis C could be cut in half with the addition of telaprevir.

"Standard treatment for the most common type of hepatitis C is 48 weeks of a combination of two drugs, peginterferon alfa-2a and ribavirin, which cures less than half of patients and has significant side effects that make it very difficult for some patients to continue their treatment," said the study's lead researcher John McHutchison, a hepatologist and gastroenterologist and researcher at the DCRI.

"Our study found that by combining the standard therapy with the direct anti-viral drug telaprevir, we could reduce the duration of treatment by 50 percent, to 24 weeks, and, at the same time, improve the cure rate by 50 percent."

The randomized Phase IIb, double-blinded study, funded by telaprevir's maker Vertex Pharmaceuticals, involved 250 patients on four trial arms.

The researchers measured rates of sustained viral response (SVR) defined as 24 weeks during which the hepatitis C virus remains undetectable in the body after the completion of therapy.

"We can now sit down with our patients and tell them that 2 of 3 patients can be cured with a 24-week course of therapy," said Dr. McHutchison.

"We observed that 67 percent of patients who received standard therapy for 48 weeks in conjunction with 12 weeks of telaprevir were cured of their hepatitis C," he said.

"The rate was 61 percent in the group that took the standard therapy for only 24 weeks in combination with 12 weeks of telaprevir, suggesting that many patients may respond to treatment in only six months as compared to about eleven months, which is significant for this patient population, because the side effects of treatment can be so intense."

While reporting success of trials among patients using telaprevir alongside traditional hepatitis C treatment, researchers noted that the addition of the experimental drug resulted in some added side effects, including rash, nausea and anemia.

"Treating genotype 1 hepatitis C, the most common form of the infection in the United States, can be challenging because the side effects are difficult for many people to endure, the duration of treatment is long, and traditionally less than half of patients are able to be cured of their disease," said Andrew Muir, a gastroenterologist at Duke and a senior investigator on the study.

"Even though telaprevir does produce side effects of its own, its addition to standard therapy was able to improve response rates and shorten the duration of treatment necessary "“ either one alone would have been an advance, and to be able to achieve both is a significant step in the right direction when it comes to treating hepatitis C."

According to the Associated Press, telaprevir is not available commercially. The company expects to seek government approval next year.

Hepatitis C is an infectious disease that can lead to fibrosis and cirrhosis of the liver. It is reported among about 3.2 million Americans and 180 million people worldwide.

The study is been published in the April 30 issue of the New England Journal of Medicine.


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