New weapon fights hepatitis C

Experimental drug clears hurdle on its way to joining standard drug combinations

Ten years ago, John McHutchison never used the word “cure” when discussing hepatitis C with his patients. But the results seen from drugs cleared for use since then — and particularly a new drug now in the final stages of testing — are changing that, says the gastroenterologist from Duke University in Durham, N.C.

“As far as these patients are concerned, they’re pretty much cured,” McHutchison says. “We don’t need to see them anymore.”

The new drug, called telaprevir, works with a standard hepatitis C drug combination to clear the virus from patients’ blood substantially better than the standard treatment alone, according to a study coauthored by McHutchison and another study, both in the April 30 New England Journal of Medicine. The new findings, in people getting their first course of drugs for the disease caused by the virus, also indicate that typically lengthy hepatitis C treatment could be halved with telaprevir’s addition.

“Telaprevir appears to be a material advance in the therapy of hepatitis C, beginning a new era of treatment,” says physician Jay Hoofnagle of the National Institute of Diabetes and Digestive and Kidney Diseases in Bethesda, Md., writing in an editorial in the same NEJM issue. Unlike existing hepatitis drugs, telaprevir is a protease inhibitor.

A third study finds that about half of people who hadn’t responded to initial treatment for hepatitis C or had relapsed cleared the virus after getting the combination including telaprevir. Those data were presented April 25 in Copenhagen at a meeting of the European Association for the Study of the Liver.

In general, patients are considered cured if they don’t have detectable hepatitis C virus for six months after drug treatment. More than 99 percent of such patients continue to stay free of the virus for the next five years, says Jean-Michel Pawlotsky, a hepatologist at the Henri Mondor Hospital in Créteil, France, and coauthor of the other study in NEJM.

The researchers agree that the drug can cure many of those patients who have received treatment but were still fighting a losing battle with hepatitis C.

“We had to tell them we had nothing to offer,” Pawlotsky says. “Now there might be something to offer.”

McHutchison and his colleagues randomly assigned 250 hepatitis C patients to get the standard drugs ribavirin and peginterferon alfa-2a, with or without telaprevir. The team found that 61 to 67 percent of those getting telaprevir were cured, compared with 41 percent of those not getting it.

Pawlotsky and his colleagues looked at 334 patients in Europe. The cure rates ranged from 60 to 69 percent with telaprevir compared with 46 percent with ribavirin and peginterferon alfa-2a alone, Pawlotsky says.

Both studies in NEJM found that taking telaprevir for three months and the standard drugs for five and a half months worked as well as taking the standard drugs for the usual 11-month course.

In the study reported at the Copenhagen meeting, 453 patients who had failed to respond to earlier treatment or had relapsed afterward were similarly assigned to get telaprevir or not as part of a combination. Hepatologist Michael Manns of the Hannover Medical School in Germany and his colleagues reported that slightly more than half of those getting telaprevir were cured, compared with only 14 percent of those getting just standard drugs.

The studies were funded by Vertex Pharmaceuticals of Cambridge, Mass., which makes telaprevir. Schering-Plough also makes a protease inhibitor, called boceprevir, which tested well against first-time–treated hepatitis C patients, according to other researchers presenting data at the Copenhagen meeting.

About 3.2 million people in the United States have hepatitis C. It infects about 180 million people worldwide. Hepatitis C can cause fatigue, fever, jaundice and abdominal pain. Patients who fail to improve during treatment or who relapse afterward risk developing cirrhosis of the liver and liver cancer. The virus comes in four varieties. In these studies, all patients had genotype 1, the most common and difficult-to-treat kind in Europe and North America.

Both telaprevir and boceprevir are currently in large-scale trials now. McHutchison says he expects both to get approved, possibly as early as 2011.

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