Resource Logo
CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

UNITED STATES: US: Do Not Mix Merck Hepatitis Pill with HIV Drugs




 

Reuters (04.26.12) - Monday, April 30, 2012

The Food and Drug Administration (FDA) said Thursday it is changing the label for Merck & Co.'s hepatitis C virus (HCV) treatment Victrelis following studies indicating it should not be taken with some common HIV drugs.

"Co-administration [of the two drugs] ... is not recommended at this time because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV ... in the blood to increase," FDA said.

Victrelis (boceprevir) was approved last May. FDA and Merck first warned about the issue in February after results of a drug interaction study of healthy patients who took Victrelis and the widely used HIV drug Norvir (ritonavir) as part of a combination protease inhibitor regimen. The study found Victrelis reduced the concentrations of HIV drugs in the blood.

A second, small clinical trial of 98 people presented last month also contributed to FDA's labeling decision, though its results were not as conclusive as the drug interaction study. Some of the HCV/HIV co-infected patients were given Victrelis plus peginterferon/ribavirin, while others received only peginterferon/ribavirin; all patients were given a type of HIV drug. Of 64 patients taking Victrelis, three had a rebound in their HIV, compared to four of the 34 taking the older combination HCV treatment.

Merck said it plans to conduct a larger drug interaction study of Victrelis with other HIV drugs. FDA said it will report any new information about Victrelis and those treatments when it becomes available.

To view the announcement, visit http://www.fda.gov/Drugs/DrugSafety/ucm301616.htm?utm_campaign =Google2&utm_source=fdaSearch&utm_medium=website&utm_term=vict relis&utm_content=6.



 


Copyright © 2012 -CDC Prevention News Update, Publisher. All rights reserved to Information, Inc., Bethesda, MD. The CDC National Center for HIV, STD and TB Prevention provides the following information as a public service only. Providing synopses of key scientific articles and lay media reports on HIV/AIDS, other sexually transmitted diseases and tuberculosis does not constitute CDC endorsement. This daily update also includes information from CDC and other government agencies, such as background on Morbidity and Mortality Weekly Report (MMWR) articles, fact sheets, press releases and announcements. Reproduction of this text is encouraged; however, copies may not be sold, and the CDC HIV/STD/TB Prevention News Update should be cited as the source of the information. Contact the sources of the articles abstracted below for full texts of the articles.



Information in this article was accurate in April 30, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.