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 Panel.
"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 prescription.
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 Family Foundation.
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 http://www.niaid.nih.gov.
The above story is based on materials provided by National Institute Of Allergy And Infectious Diseases. Note: Materials may be edited for content and length.
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