Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents
INTRODUCTION
These guidelines were developed by the Panel on Clinical Practices for
Treatment of HIV Infection, convened by the Department of Health and Human
Services (DHHS) and the Henry J. Kaiser Family Foundation. The guidelines
contain recommendations for the clinical use of antiretroviral agents in
the treatment of adults and adolescents (defined in Considerations for
Antiretroviral Therapy in the HIV-Infected Adolescent) who are infected
with the human immunodeficiency virus (HIV). Guidance for the use of antiretroviral
treatment in pediatric HIV infection is not contained in this report. Although
the pathogenesis of HIV infection and the general virologic and immunologic
principles underlying the use of antiretroviral therapy are similar for
all HIV-infected persons, unique therapeutic and management considerations
apply to HIV-infected children. In recognition of these differences, a
separate set of guidelines will address pediatric-specific issues related
to antiretroviral therapy.
These guidelines are intended for use by physicians and other healthcare
providers who use antiretroviral therapy to treat HIV-infected adults and
adolescents. The recommendations contained herein are presented in the
context of and with reference to the first section of this report, Principles
of Therapy for HIV Infection, formulated by the National Institutes of
Health (NIH) Panel to Define Principles of Therapy of HIV Infection. Together,
these reports provide the pathogenesis-based rationale for therapeutic
strategies as well as practical guidelines for implementing these strategies.
Although the guidelines represent the current state of knowledge regarding
the use of antiretroviral agents, this field of science is rapidly evolving,
and the availability of new agents or new clinical data regarding the use
of existing agents will result in changes in therapeutic options and preferences.
The Antiretroviral Working Group, a subgroup of the Panel, will meet several
times a year to review new data; recommendations for changes in this document
would then be submitted to the Panel and incorporated as appropriate. Copies
of this document and all updates are available from the CDC National AIDS
Clearinghouse (1-800-458-5231) and are posted on the Clearinghouse World
Wide Web site( http://www.cdcnac.org). In addition, copies and updates
also are available from the HIV/AIDS Treatment Information Service (1-800-
448-0440; Fax 301-519-6616; TTY 1-800-243-7012) and on the ATIS World Wide
Web site (http://www.hivatis.org). Readers should consult these web sites
regularly for updates in the guidelines. These recommendations are not
intended to substitute for the judgment of a physician who is expert in
caring for HIV-infected persons. When possible, the treatment of HIV-infected
patients should be directed by a physician with extensive experience in
the care of these patients. When this is not possible, the physician treating
the patient should have access to such expertise through consultations.
Each recommendation is accompanied by a rating that includes a letter
and a Roman numeral (Table 1), similar to the rating schemes described
in previous guidelines on the prophylaxis of opportunistic infections (OIs)
issued by the U.S. Public Health Service and the Infectious Diseases Society
of America (1). The letter indicates the strength of the recommendation
based on the opinion of the Panel, and the Roman numeral rating reflects
the nature of the evidence for the recommendation (Table 1).
Thus, recommendations based on data from clinical trials with clinical
endpoints are differentiated from recommendations based on data derived
from clinical trials with laboratory endpoints (e.g., CD4+T cell count
or plasma HIV RNA levels); when clinical trial data are not available,
recommendations are based on the opinions of experts familiar with the
relevant scientific literature. The majority of current clinical trial
data regarding the use of antiretroviral agents has been obtained in trials
enrolling predominantly young to middle-aged males. Although current knowledge
indicates that women may differ from men in the absorption, metabolism,
and clinical effects of certain pharmacologic agents, clinical experience
and data available to date do not indicate any substantial sex differences
that would modify these guidelines. However, theoretical concerns exist,
and the Panel urges continuation of the current efforts to enroll more
women in antiretroviral clinical trials so that the data needed to reevaluate
this issue can be gathered expeditiously.
This report addresses the following issues: the use of testing for plasma
HIV RNA levels (viral load) and CD4+T cell count; initiating therapy in
established HIV infection; initiating therapy in patients who have advanced-stage
HIV disease; interruption of antiretroviral therapy; changing therapy and
available therapeutic options; the treatment of acute HIV infection; antiretroviral
therapy in adolescents; and antiretroviral therapy in the pregnant woman.
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