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Two Winning Drug Tests, One Expected and One a Surprise

[2008-4-9]

An experimental drug from Vertex Pharmaceuticals helped cure more than 60 percent of patients with a tough-to-treat form of hepatitis C, according to data to be presented at a medical meeting that starts today.

The results, eagerly awaited by Wall Street as well as by doctors, represent the highest cure rate yet reported for the condition -- and the treatment was accomplished in half the usual time.

But Vertex might have to share a bit of the limelight with Romark Laboratories, a tiny privately held company that already sells a drug called Alinia that is used to treat diarrhea caused by certain parasites but that suddenly is emerging as a potential treatment for hepatitis C.

In a presentation that has escaped the attention of Wall Street, though it is to be made at the same meeting, researchers are to report that Alinia helped cure as many as 79 percent of hepatitis C patients, although they had a form of the virus that might be slightly easier to treat than the type Vertex took on.

''There will be skepticism because this has come out of right field,'' said Dr. Emmet B. Keeffe, chief of hepatology at Stanford, who is a consultant to Romark. But Dr. Keeffe said that he had overcome his own initial skepticism and that the results were ''pretty exciting.''

Both developments, experts said, will need to be followed up by larger trials. But the progress could be important for patients. At least three million Americans are thought to be infected with the hepatitis C virus, and the number of cases of liver cirrhosis and liver cancer caused by the virus is rising.

The existing treatment -- a combination of two drugs, alpha interferon and ribavirin -- can cause debilitating side effects like flulike symptoms, anemia and depression. The treatment for type 1 hepatitis C, the hard-to-treat form that accounts for 70 percent of the cases in the United States, takes nearly a year.

So the hunt for new drugs has been intense, and Vertex, a publicly traded company based in Cambridge, Mass., is widely acknowledged as the front-runner. Its pill, called telaprevir or VX-950, interferes with a viral enzyme. This is how most AIDS drugs work, but it is a new approach for hepatitis C.

The Romark data come from a study in Egypt of only 96 previously untreated patients. Alinia, also known as nitazoxanide, had previously been tested there as a treatment for parasites.


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