Dear
Healthcare Professional:
Bristol-Myers
Squibb would like to inform you that therapy with Baraclude
(entecavir) is not recommended
for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral
therapy (HAART) due to the potential for the development of HIV (human immunodeficiency
virus) resistance.
Accordingly,
the Baraclude Full Prescribing Information has been updated to
include the following information in the boxed WARNINGS [1]:
"Limited
clinical experience suggests there is a potential for the development of resistance
to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors
if BARACLUDE is used to treat chronic hepatitis B virus infection in patients
with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended
for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral
therapy (HAART). See WARNINGS: Co-infection with HIV."
In
addition, the MICROBIOLOGY section of the Baraclude
Full Prescribing Information has been revised to include the following additional
information:
Antiviral
Activity against HIV
"A
comprehensive analysis of the inhibitory activity of
entecavir against a panel of laboratory and clinical
human immunodeficiency virus type 1 (HIV-1) isolates using a variety of cells
and assay conditions yielded EC50 values ranging from 0.026 to >
10 μM; the lower EC50 values were observed
when decreased levels of virus were used in the assay. In cell culture, entecavir
selected for an M184I substitution in HIV reverse transcriptase at micromolar
concentrations, confirming inhibitory pressure at high entecavir
concentrations. HIV variants containing the M184V substitution showed loss of
susceptibility to entecavir."
Consistent
with clinical practice guidelines for chronic hepatitis B management [2,3]
the WARNINGS section of the Baraclude Full Prescribing
Information has been updated with the following information:
"Before
initiating BARACLUDE therapy, HIV antibody testing should be offered to all patients.
BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use."
Other
changes in the WARNINGS and PRECAUTIONS sections and PATIENT
INFORMATION have been made consistent with the information described above.
Please refer to the enclosed Baraclude Full Prescribing Information, including boxed WARNINGS,
for more information.
Bristol-Myers
Squibb remains committed to providing
you the most current and accurate information available for our products.
If
you have any questions about this new information or require additional medical
information, please contact Bristol-Myers Squibb at 1-800-321-1335.
If
you have had a patient who experienced an adverse event following, or coincident
with the use of Baraclude (entecavir), please contact
Bristol-Myers Squibb at 1-800-321-1335 or the FDA MedWatch
program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787).
Please
refer to the accompanying Important Information about Baraclude and the enclosed Baraclude
Full Prescribing Information, including boxed WARNINGS.
