Merck, Vertex Hepatitis Drugs Up For FDA Review This Week
Hepatitis C is caused by the virus HCV. It is spread the same way as hepatitis B, through contact with an infected person's blood, semen, or body fluid. Like hepatitis B, hepatitis C causes swelling of the liver and can cause liver damage that can lead to cancer. Most people who have hepatitis C develop a chronic infection. This may lead to a scarring of the liver, called cirrhosis. Blood banks test all donated blood for hepatitis C, greatly reducing the risk for getting the virus from blood transfusions or blood products.
Study results were announced at the 44th annual meeting of the European Association for the Study of the Liver in Copenhagen in April, 2009. When used in combination with peginterferon alfa-2b and ribavirin, boceprivir use resulted in significantly higher sustained viral response (SVR) rates in the most difficult-to-treat patients with genotype 1.
Boceprevir faces a review by the FDA's Antiviral Drugs Advisory Committee this week. A similar product, telaprevir, from Vertex Pharmaceuticals Inc., will be reviewed by the panel also. Both drugs are widely expected to be recommended for approval, as they have shown strong effectiveness in improving the cure rates in patients that use standard therapy for the liver disease. Both drugs are known as protease inhibitors, which are designed to block an enzyme that helps the hepatitis C virus replicate.
Hepatitis C is a liver disease caused by infection with the hepatitis C virus, which is spread when the blood of an infected person enters the body of someone previously not infected. The Centers for Disease Control and Prevention said most people become infected by sharing needles or other equipment used to inject drugs, although the agency said people who receive body piercings or tattoos with nonsterile instruments are also at risk of becoming infected with hepatitis C. About 3.2 million Americans are infected with hepatitis C.
The FDA is being very open about the risks however of these new drugs. They state than there is an "increased frequency and severity of anemia" or a decrease in the number of red blood cells when boceprevir is added to pegylated interferon and ribavirin, two other drugs currently used to treat hepatitis C.
The Administration is also making public that there was an increased number of reported psychiatric symptoms of "suicidal and homicidal ideation" in the boceprevir arms of the studies compared to the control groups. However, the FDA said "it is difficult to make any meaningful clinical conclusions from this observation." Reports of suicidal ideation occurred in less than 1% of patients in the studies.
Merck, in a document also posted on FDA's website, said boceprevir "fulfils a significant unmet medical need" for the treatment of hepatitis C infection. Merck has proposed a brand name of Victrelis for boceprevir.
We will see if these new proposed drugs will be released in an effort to battle hepatitis C. Stay tuned.
Sources: The New England Journal of Medicine and The U.S. Food and Drug Adminstration
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