An updated version of the "Guidelines for the Use of Antiretroviral Agents in
HIV-Infected Adults and Adolescents" has been posted to the AIDS Treatment
Information Service (ATIS) Web site, www.hivatis.org.
The Guidelines were developed by the Panel on Clinical Practices for the
Treatment of HIV Infection, a joint effort of the Department of Health and
Human Services and the Henry J. Kaiser Family Foundation. The Guidelines
were constructed as a "living document" and are updated frequently by the
"We feel that the Guidelines are an invaluable resource to all health care
providers who care for HIV-infected individuals," says Anthony S. Fauci,
M.D., director of the National Institute of Allergy and Infectious Diseases
(NIAID) and co-chair of the Panel. The Guidelines were published in
hard-copy form in the Morbidity and Mortality Weekly Report and in the
Annals of Internal Medicine in 1998; however, they are updated frequently on
the ATIS Web site. In addition, a hard copy of the most recent version of
the Guidelines can be obtained for free by calling 1-800-448-0440.
Included in the latest version of the Guidelines are recommendations for the
use of the recently approved anti-HIV drug abacavir (trade name Ziagen).
Abacavir is a potent anti-HIV agent belonging to a class of drugs known as
nucleoside analog reverse transcriptase inhibitors. This family of drugs
also includes zidovudine (AZT) and lamivudine (3TC).
Clinical trials of abacavir combined with AZT and 3TC have shown that this
combination suppresses HIV replication and boosts CD4+ T-cell counts to a
degree comparable to widely used treatment regimens that combine a protease
inhibitor drug with AZT and 3TC. CD4+ T cells are the crucial immune system
cells depleted during the course of HIV disease.
The Panel notes that the potential advantages of the abacavir+AZT+3TC
regimen include ease of administration (two pills twice daily), and the
opportunity to save other classes of potent anti-HIV drugs, some with a
higher incidence of undesirable side effects, for later use.
However, "The Panel is concerned about the ability of the abacavir+AZT+3TC
regimen to adequately suppress HIV replication in individuals with high
baseline levels of plasma viral load," says John G. Bartlett, M.D., chief of
the division of infectious diseases at the Johns Hopkins University Medical
Center and co-chair of the Panel.
In addition, abacavir has been associated with a hypersensitivity syndrome
that can be life-threatening. In clinical trials, the hypersensitivity
syndrome associated with abacavir occurred in approximately 5 percent of
patients. In cases where the drug was discontinued because of
hypersensitivity reactions and then re-introduced, life-threatening
exacerbations of the hypersensitivity syndrome occurred. A medication guide
and warning card providing information about recognizing the abacavir
hypersensitivity syndrome should be dispensed with each abacavir
Currently, the Panel recommends using the abacavir-containing regimen as an
"alternative" to the preferred regimens delineated in the Guidelines, which
include two nucleoside analog reverse transcriptase inhibitors in
combination with either a protease inhibitor or efavirenz, a non-nucleoside
reverse transcriptase inhibitor.
The Panel also considered recently published data suggesting that
HIV-infected women experience more rapid disease progression compared with
men who have the same level of virus in their bloodstream. These data were
obtained in studies of women who were injecting drug users, and the results
have not been consistently observed in other studies. The Panel therefore
did not recommend that women begin antiretroviral therapy earlier than men,
but will continue to closely follow developments in this field.
The revised Guidelines also include a hypertext link to a brief discussion
of the controversy surrounding the use of the drug hydroxyurea in the
treatment of HIV infection. In addition, tables and charts in the
Guidelines have been updated and reorganized in a more user-friendly way.
In the near future, the Panel will issue an additional update to the
Guidelines delineating its recommendations regarding the use of the recently
approved protease inhibitor, amprenavir (Agenerase).
Co-conveners of the Panel on Clinical Practices for the Treatment of HIV
Infection are Eric Goosby, M.D., on behalf of the Department of Health and
Human Services, and Sophia Chang, M.D., on behalf of the Henry J. Kaiser
NIAID is a component of the National Institutes of Health (NIH). NIAID
conducts and supports research to prevent, diagnose and treat illnesses such
as HIV disease and other sexually transmitted diseases, tuberculosis,
malaria, asthma and allergies. NIH is an agency of the U.S. Department of
Health and Human Services.
The Henry J. Kaiser Family Foundation, based in Menlo Park, Calif., is an
independent health care philanthropy and is not associated with Kaiser
Permanente or Kaiser Industries.
Press releases, fact sheets and other NIAID-related materials are available
on the NIAID Web site at www.niaid.nih.gov.