Agency releases HIV guidelines

August 1, 1997
Pharmaceutical Representative

New guidelines for the treatment of adult and adolescent patients with HIV were recently released by the Department of Health and Human Services and the Henry J. Kaiser Family Foundation.

New guidelines for the treatment of adult and adolescent patients with HIV were recently released by the Department of Health and Human Services and the Henry J. Kaiser Family Foundation.

The guidelines were developed by the Panel on Clinical Practices for Treatment of HIV Infection. The panel was comprised of federal, private sector and academic experts, as well as AIDS interest groups' representatives, health policy groups and payer organizations.

"These guidelines will help standardize and improve the quality of care for HIV-infected persons in the United States," said Sophia Chang, M.D., director of HIV programs for the Kaiser Family Foundation.

Three-prong therapy

The panel focused heavily on the proper use of protease inhibitors, drugs commonly combined with other AIDS medications to create three-drug "cocktails."

According to the guidelines, doctors should begin treatment with three drugs: two nucleoside analogs with one protease inhibitor.

Monotherapy is recommended, however, for HIV-infected pregnant women trying to prevent transmission of the virus to their babies. In cases where the women are healthy and do not require antiretroviral drugs for their own treatment, zidovudine (AZT) used alone can reduce prenatal transmission by 70% to 80%. It should be administered as early as the 14th week and used throughout the pregnancy, including intravenously during labor and delivery. Following birth, the newborn must be treated with the drug during its first six weeks of life.

Treatment strategies

The guidelines recommended aggressive treatment until the HIV virus is barely detectable. They also emphasized the importance of monitoring both the amount of HIV in the patient's blood and the number of CD4+ T-cells, the immune system cells that fight infection, every three or four months.

When patients show signs of resistance, such as increased levels of HIV in the blood, doctors should determine whether the resistance is a result of drug toxicity or drug failure. In cases of drug toxicity, they should substitute one or more alternative medications; in cases of drug failure, they should change at least two drugs, although replacing all three is optimal.

Treatment of one or two nucleoside analogs without a protease inhibitor is not recommended. If patients must stop antiretroviral therapy for an extended time, they should stop all antiretroviral drugs simultaneously to avoid encouraging resistant viral strains.

The panel also stated that physicians and patients should be warned of treatment risks, including drug toxicity and dosing restraints. They should also be aware of the potential for developing drug resistance, the need for indefinite therapy and the possibility that treatment may prevent patients from benefiting from future treatment options.

The panel did not make recommendations for treatment of HIV in children and infants, but may release pediatric guidelines within the next six months. Updates will be made as necessary. Detailed copies of the guidelines are posted on the Internet at http://www.cdcnac.org (National AIDS Clearinghouse's Web site) and http://www .hivatis.org (HIV/AIDS Treatment Information Service's Web site). PR