Persons using assistive technology might not be able to fully access information in this file. For assistance, please send e-mail to: mmwrq@cdc.gov. Type 508 Accommodation and the title of the report in the subject line of e-mail.
Notice to Readers: Updated Information Regarding Antiretroviral
Agents Used as HIV Postexposure Prophylaxis for Occupational HIV Exposures
In 1996, the U.S. Public Health Service first recommended using antiretrovirals as postexposure prophylaxis
(PEP) after occupational exposure to human immunodeficiency virus (HIV)
(1). Since the updated HIV PEP
recommendations in 2005 (2), two important changes to antiretroviral use have occurred that affect the management of
occupational exposures.
First, Kaletra® (Abbott Laboratories, Abbott Park,
Illinois), a combination protease inhibitor, is no longer
available in its original formulation: capsules containing 133 mg of lopinavir and 33 mg of ritonavir. Although the
recommended daily prescribed amount of Kaletra ingredients is unchanged, the dosing regimen has changed as a result of the
new Kaletra formulation. The previous dosing regimen for the capsule formulation was three capsules twice daily. Kaletra
is now manufactured only in tablet form, with each tablet containing 200 mg of lopinavir and 50 mg of ritonavir.
To achieve the same recommended daily prescribed amount of the tablet formulation, two tablets of 200 mg of
lopinavir and 50 mg of ritonavir should be taken twice daily. Health-care providers should not prescribe three tablets twice a
day of the new Kaletra formulation; that dose would be the equivalent of 1,200 mg of lopinavir and 300 mg of
ritonavir daily, a higher dose than the recommended 800 mg of lopinavir and 200 mg of ritonavir daily.
Second, on September 10, 2007, Pfizer, Inc. issued a
letter* warning health-care providers about the use of
Viracept® (nelfinavir) (Pfizer, Inc., New York, New York), another protease inhibitor, because the Viracept manufactured
in Europe contained high levels of ethyl methane mesylate (EMS). EMS is a byproduct of the manufacturing process and
a known animal carcinogen, mutagen, and teratogen. The level at which EMS might become carcinogenic or
teratogenic in humans is not known. The warning in the letter applies to pregnant women and states that information about
the ability of EMS to cross the placenta or to enter breast milk is currently unknown. A review of data from
the Antiretroviral Pregnancy Registry, which collects data on approximately 6,000 HIV-infected pregnant women,
indicated that, during January 1989--January 2007, no statistically significant difference was observed in the prevalence of
birth defects among the infants of women who used Viracept compared with those whose mothers used other
antiretroviral therapies (3). Nonetheless, the Food and Drug Administration (FDA) recommends that pregnant women limit
their exposure to EMS during pregnancy. Until further notice, pregnant women who need to begin antiretroviral therapy
or HIV PEP should not be offered regimens containing Viracept. As a precautionary measure, pregnant women
currently receiving Viracept should be switched to an alternative antiretroviral therapy while Pfizer and FDA work to implement
a long-term EMS specification for Viracept. Specific recommendations for use of antiretroviral agents in pregnant
HIV-1--infected patients are indicated in the U.S. Department of Health and Human Services guidelines
(4) and can be consulted to determine an alternative treatment option.
Because nearly 80% of U.S. health-care personnel are
female (5) and many of these women are of child-bearing
age, this updated information about Viracept might be
relevant to the choice of drugs included in an HIV PEP
regimen taken by female health-care personnel. Additional information and guidance regarding management of
specific exposures are available from the National Clinicians' Post-Exposure Prophylaxis Hotline by telephone (888-448-4911) or
online (http://www.ucsf.edu/hivcntr).
Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry international interim report for 1 January 1989 through
31 January 2007. Wilmington, NC: Registry Coordinating Center; 2007. Available at
http://www.apregistry.com.
US Department of Health and Human Services, Panel on Clinical Practices for Treatment of HIV Infection. Guidelines for the use of
antiretroviral agents in HIV-1-infected adults and adolescents---December 1, 2007. Available at
http://aidsinfo.nih.gov/contentfiles/adultandadolescentgl.pdf.
US Department of Labor, Bureau of Labor Statistics. Employed persons by detailed industry and sex, 2006 annual average. Available at
http://www.bls.gov/cps/wlf-table14-2007.pdf.
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of
Health and Human Services.References to non-CDC sites on the Internet are
provided as a service to MMWR readers and do not constitute or imply
endorsement of these organizations or their programs by CDC or the U.S.
Department of Health and Human Services. CDC is not responsible for the content
of pages found at these sites. URL addresses listed in MMWR were current as of
the date of publication.
Disclaimer
All MMWR HTML versions of articles are electronic conversions from ASCII text
into HTML. This conversion may have resulted in character translation or format errors in the HTML version.
Users should not rely on this HTML document, but are referred to the electronic PDF version and/or
the original MMWR paper copy for the official text, figures, and tables.
An original paper copy of this issue can be obtained from the Superintendent of Documents,
U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800.
Contact GPO for current prices.
**Questions or messages regarding errors in formatting should be addressed to
mmwrq@cdc.gov.
