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New Hepatitis C Drug Close to Gaining FDA Approval

Last Updated: April 28, 2011.

 

Agency panel gives unanimous support to telaprevir, boceprevir as treatments for liver-damaging disease

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Agency panel gives unanimous support to telaprevir, boceprevir as treatments for liver-damaging disease.

THURSDAY, April 28 (HealthDay News) -- Two new drugs that could change the way hepatitis C is treated have been unanimously recommended for approval by a panel of U.S. health experts.

On Thursday, a Food and Drug Administration advisory committee voted 18-0 that telaprevir, made by Vertex Pharmaceuticals Inc., is both safe and effective despite a high rate of rashes that has been reported among those taking it. On Wednesday, the same panel threw its full support behind boceprevir, a new medication from Merck & Co.

Although not required to follow the recommendations of its expert panels, the FDA typically does; a final decision is expected by May 23. The agency convened the two-day meeting to review both drugs, which block the enzyme that allows the hepatitis virus to replicate. Many experts believe that, if approved, boceprevir and telaprevir could revolutionize treatment of hepatitis C-linked disease.

The U.S. Centers for Disease Control and Prevention estimated 17,000 new hepatitis C virus infections in the United States in 2007. Many people with the disease have no symptoms until it has caused liver damage, sometimes so severe that a liver transplant is needed.

Intravenous drug users are particularly susceptible to the disease.

Studies found that when used with two older drugs, boceprevir reduced levels of the virus more effectively than the existing treatments. Merck hopes to sell the medication under the brand name Victrelis, according to Dow Jones.

Debra Birnkrant, director of the FDA's antiviral drugs division, said that both medications appear to increase the cure rate "to more than 30 percent above what we have today," Dow Jones reported.

The new drugs take treatment of hepatitis C in a new direction. Both boceprevir and telaprevir block protease, an enzyme that helps the virus reproduce. The earlier drugs, pegylated interferon and ribavirin, were meant to boost the immune system's defense against the virus. Together, the combined medications may offer new hope for the thousands of Americans with the contagious liver disease.

Asked if the available data supported use of boceprevir in combination with standard treatment of pegylated interferon and ribavirin, the panel of medical experts voted 18-0 in favor of its approval on Wednesday, Dow Jones reported.

One of the boceprevir studies found it effective for 66 percent of patients taking the three-drug regimen compared to 38 percent of those who received the standard two-drug treatment, Dow Jones said.

Some concerns still need to be addressed, including how to treat black patients, for whom the drugs seem to be less effective.

Studies submitted by the manufacturers showed the new drugs, when added to existing treatments, shortened the length of medication therapy, thereby reducing potential side effects. Patients currently require nearly 12 months of treatment.

Telaprevir's cure rates appear to be better than boceprevir's, the Associated Press reported.

Until the early 1990s, when testing of the nation's blood supply became routine, hepatitis C was often contracted from blood transfusions. Today, it is most commonly associated with injection drug use. It is also transmitted through sexual contact with an infected person, the CDC said.

Earlier this year, a study from the Johns Hopkins School of Public Health called for greater efforts to reduce the population of hepatitis C-infected injection drug users. That study found that new cases of hepatitis C were decreasing only among younger injection drug users who had recently starting using the drugs.

More information

To learn more about hepatitis C, visit the U.S. National Library of Medicine.

SOURCES: U.S. Centers for Disease Control and Prevention; Associated Press

Copyright © 2011 HealthDay. All rights reserved.


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