Friday, November 30, 2007

Pill makes it easier to boost platelets in Hepatitis C patients
by Kelly Winget, DCRI Communications

Many patients with the Hepatitis C virus (HCV) develop low platelet levels, which is a major reason that they can't endure necessary antiviral treatments. Previously, patients had to rely on drug infusions or injections to boost their platelet count, but a new drug appears to be an effective alternative.

Eltrombopag is a pill that can be taken once a day, and DCRI researchers have learned that it boosts platelet counts in a majority of patients at three different dosage levels. Patients in the trial were then able to start or continue conventional antiviral treatment.

John McHutchison, MD, associate director of the DCRI, led the multi-center, world-wide phase II drug trial of GlaxoSmithKline's eltrombopag. It is marketed as Promacta in the U.S. and Revolade in Europe. The trial enrolled 74 patients with low platelet counts and cirrhosis of the liver caused by an HCV infection.

The results are published in the November 29 issue of New England Journal of Medicine.

“We feel this is an important development for many people infected with the hepatitis C virus world-wide,” said McHutchison. “A significant number of patients with HCV infection will at some point develop platelet problems that will compromise their getting the best treatments we have. Anything we can do to prevent that from happening would improve their care.”

Participants in the trial were randomized to be in a control group or to receive 30, 50 or 75 milligrams of eltrombopag daily. All of the patients had platelet levels between 20,000 and 70,000. A normal range is between 145,000 and 450,000.

The trial was testing the safety and effectiveness of the drug at different doses. Researchers found that patients responded better with higher amounts of eltrombopag. Among the participants who received the lowest dose of the drug, 74 percent saw a significant increase in their platelet counts. But 79 percent and 95 percent of patients who received the higher doses saw significant increases in their platelets.

“We are encouraged by these results and are already working on another multi-center, international, phase III trial where we hope these results will be confirmed,” said McHutchison.

Approximately 4 million people in the U.S. and 170 million worldwide carry the hepatitis C virus. The virus causes inflammation and scarring in the liver. Although it is curable for roughly half of those who have it, it can cause significant liver damage, liver cancer and death when not treated effectively. HCV infection is a common cause of cirrhosis and the most common reason that patients require a liver transplant.