Draft HIV/AIDS Treatment Guidelines Available

June 23, 1997

All people with CDC-defined AIDS should receive combination antiretroviral therapy, preferably with three drugs including a protease inhibitor, according to comprehensive new Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents, made available today for public comment. The Guidelines were developed by the Panel on Clinical Practices for Treatment of HIV Infection, which was convened jointly by the Department of Health and Human Services (DHHS) and the Henry J. Kaiser Family Foundation.

"The decisions about treatments for people with HIV/AIDS should be guided by regular monitoring of the amount of HIV in the patient's blood (viral load) as well as the number of CD4+ T cells, the immune system cells that fight infection," says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

Dr. Fauci and John G. Bartlett, M.D., professor of medicine and chief of infectious diseases, Johns Hopkins University School of Medicine, co-chair the Panel that includes federal, private sector and academic experts in the clinical treatment and care of HIV-infected people, as well as representatives of AIDS interest groups, health policy groups and payer organizations.

The Guidelines recommend starting treatment with three drugs and changing at least two drugs when there are indications that treatment is failing, such as when HIV levels in the blood increase. Treatment with only two drugs, in general, is considered less than optimal.

Treatment with only one drug is not recommended. However, zidovudine (AZT) as monotherapy is recommended as prophylaxis to prevent HIV transmission to a baby and should be given to relatively healthy HIV-infected pregnant women who do not require antiretroviral drugs for their own treatment. These women and their newborns should receive AZT, according to the regimen recommended by the Public Health Service Task Force, to reduce the risk of HIV transmission to the babies.

HHS Secretary Donna E. Shalala praised the Panel for its efforts. "Today, we are providing much-needed guidance to patients and medical practitioners," Shalala said. "We have reason to celebrate that a diagnosis of HIV disease is no longer an automatic death sentence. At the same time, we recognize that these new medical guidelines raise important public policy issues, and we're working rapidly to address them."

DHHS Office of HIV/AIDS Policy and the Kaiser Family Foundation convened the three-year panel in December 1996. "We recognize that treatment decisions have become increasingly complex with the many new drugs available and new ways of monitoring disease progression. The Guidelines, which will be updated periodically, reflect the current state of knowledge about HIV disease and antiretroviral drugs," says Eric P. Goosby, M.D., director of the DHHS Office of HIV/AIDS Policy.

"These Guidelines will help standardize and improve the quality of care for HIV-infected persons in the United States. The Foundation is pleased to have joined with the Department of Health and Human Services in this unique public-private partnership to bring national attention to the rapid changes in HIV therapies," says Sophia Chang, M.D., director of HIV programs, Kaiser Family Foundation. "The Guidelines relied in part on a companion document, Report of the NIH Panel to Define Principles of Therapy of HIV Infection," explains Dr. Goosby, "and together they provide the scientific rationale for therapeutic strategies as well as practical guidelines for implementing the strategies."

The NIH Panel was sponsored by the NIH Office of AIDS Research and chaired by Charles C. Carpenter, M.D., professor of medicine, Brown University School of Medicine.

Panelists included AIDS clinicians and researchers. The mission of the NIH Panel was to review the current state of knowledge of antiretroviral therapies and prepare a document outlining Principles that would guide therapeutic decisions.

Both documents, announced in the Federal Register June 19, 1997, are available for a 30-day comment period. The draft documents are available from the National AIDS Clearinghouse (1-800-458-5231) and on their Web site http://www.cdcnac.org and from the HIV/AIDS Treatment Information Service (1-800-448-0440) and on their Web site http://www.hivatis.org.

After consideration of comments, both documents will be published in the Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report.

NIH/National Institute of Allergy and Infectious Diseases

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