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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=victrelis&utm_content=6.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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