Treatment Issues Vol. 11, no. 2

w ISSUES
C
Principles and Guidelines for the
Treatment of HIV Infection
July 1997
The Office of AIDS Research of the National Institutes of Health (NIH) and the Department of
Health and Human Services made public the Principles and Guidelines for the Treatment of HIV
Infection. These publications are the result of the work of two panels called to formulate both the
principles that should guide the treatment of HIV infection and the guidelines for the practical application of such principles. The two panels attempted to answer the most important questions regarding antiretroviral therapies;
1. When to start treatment.
2. What combination of drugs to use.
3. Who should start therapy.
4. Advantages and disadvantages of starting early therapy.
Principles for the Treatment of HIV Infection (Summary)
1. Ongoing HIV replication leads to immune system damage and progression to AIDS. HIV infection is always harmful, and true long-term survival free of clinically significant immune dysfunction
is unusual.
2. Plasma HIV RNA levels indicate the magnitude of HIV replication and its associated rate of
CD4+ T-cell destruction, while CD4+ T-cell counts indicate the extent of HIV-induced immune damage already suffered. Regular, periodic measurement of plasma HIV RNA levels and CD4+ T-cell
counts is necessary to determine the risk of disease progression in an HIV-infected individual and to
determine when to initiate or modify antiretroviral treatment regimens.
3. As rates of disease progression differ among individuals, treatment decisions should be individualized by level of risk indicated by plasma HIV RNA levels and CD4+ T-cell counts.
4. The use of potent combination antiretroviral therapy to suppress HIV replication to below the
levels of detection of sensitive plasma HIV RNA assays limits the potential for selection of antiretroviral-resistant HIV variants, the major factor limiting the ability of antiretroviral drugs to inhibit
virus replication and delay disease progression. Therefore, maximum achievable suppression of HIV
replication should be the goal of therapy.
5. The most effective means to accomplish durable suppression of HIV replication is the simultaneous initiation of combinations of effective anti-HIV drugs with which the patient has not been previously treated and that are not cross-resistant with antiretroviral agents with which the patient has
been treated previously.
6. Each of the antiretroviral drugs used in combination therapy regimens should always be used
according to optimum schedules and dosages.
7. The available effective antiretroviral drugs are limited in number and mechanism of action, and
cross-resistance between specific drugs has been documented. Therefore, any change in antiretroviral
therapy increases future therapeutic constraints.
8. Women should receive optimal antiretroviral therapy regardless of pregnancy status.
9. The same principles of antiretroviral therapy apply to both HIV-infected children and adults,
although the treatment of HIV-infected children involves unique pharmacologic, virologic, and
immunologic considerations.
10. Persons with acute primary HIV infections should be treated with combination antiretroviral
therapy to suppress virus replication to levels below the limit of detection of sensitive plasma HIV
RNA assays.
11. HIV-infected persons, even those with viral loads below detectable limits, should be considered infectious and should be counseled to avoid sexual and drug-use behaviors that are associated
with transmission or acquisition of HIV and other infectious pathogens.