Report of the NIH Panel to Define Principles of Therapy of HIV Infection; and, Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents
Published Date:April 24, 1998
Corporate Authors:Centers for Disease Control and Prevention (U.S.) ; Centers for Disease Control and Prevention (U.S.) ; Henry J. Kaiser Family Foundation ; ... More ▼
CD4 Lymphocyte Count
Drug Resistance, Microbial
Drug Therapy, Combination
Pregnancy Complications, Infectious
Virus Diseases In Children
Anti-HIV Agents/Therapeutic Use
HIV Infections/Drug Effects
HIV Infections/Drug Therapy
HIV Infections/Treatment/United States
Pregnancy Complications, Infectious/Drug Therapy
Virus Diseases In Children/Treatment/United States
Series:MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports; v. 47, no. RR-5
Description:Report of the NIH Panel to Define Principles of Therapy of HIV Infection / the material in this report was prepared for publication by: Mark B. Feinberg, Office of AIDS Research, National Institutes of Health, in collaboration with Jonathan E. Kaplan, Division of AIDS, STD, and TB Laboratory Research, National Center for Infectious Diseases and Division of HIV/AIDS Prevention–Surveillance, and Epidemiology, National Center for HIV, STD, and TB Prevention -- Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents / the material in this report was prepared for publication by Sharilyn K. Stanley, National Institute of Allergy and Infectious Diseases, National Institutes of Health, in collaboration with Jonathan E. Kaplan, Division of AIDS, STD, and TB Laboratory Research, National Center for Infectious Diseases and Division of HIV/AIDS Prevention–Surveillance, and Epidemiology, National Center for HIV, STD, and TB Prevention.
Report of the NIH Panel to Define Principles of Therapy of HIV Infection: Recent research advances have afforded substantially improved understanding of the biology of human immunodeficiency virus (HIV) infection and the pathogenesis of the acquired immunodeficiency syndrome (AIDS). With the advent of sensitive tools for monitoring HIV replication in infected persons, the risk of disease progression and death can be assessed accurately and the efficacy of anti-HIV therapies can be determined directly. Furthermore, when used appropriately, combinations of newly available, potent antiviral therapies can effect prolonged suppression of detectable levels of HIV replication and circumvent the inherent tendency of HIV to generate drug-resistant viral variants. However, as antiretroviral therapy for HIV infection has become increasingly effective, it has also become increasingly complex. Familiarity with recent research advances is needed to ensure that newly available therapies are used in ways that most effectively improve the health and prolong the lives of HIV-infected persons. To enable practitioners and HIV-infected persons to best use rapidly accumulating new information about HIV disease pathogenesis and treatment, the Office of AIDS Research of the National Institutes of Health sponsored the NIH Panel to Define Principles of Therapy of HIV Infection. This Panel was asked to define essential scientific principles that should be used to guide the most effective use of antiretroviral therapies and viral load testing in clinical practice. Based on detailed consideration of the most current data, the Panel delineated eleven principles that address issues of fundamental importance for the treatment of HIV infection. These principles provide the scientific basis for the specific treatment recommendations made by the Panel on Clinical Practices for the Treatment of HIV Infection sponsored by the Department of Health and Human Services and the Henry J. Kaiser Family Foundation. The reports of both of these panels are provided in this publication. Together, they summarize new dta and provide both the scientific basis and specific guidelines for the treatment of HIV-infected persons. This information will be of interest to health-care providers, HIV-infected persons, HIV/AIDS educators, public health educators, public health authorities, and all organizations that fund medical care of HIV-infected persons.
Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents: With the development and FDA approval of an increasing number of antiretroviral agents, decisions regarding the treatment of HIV-infected persons have become complex; and the field continues to evolve rapidly. In 1996, the Department of Health and Human Services and the Henry J. Kaiser Family Foundation convened the Panel on Clinical Practices for the Treatment of HIV to develop guidelines for the clinical management of HIV-infected persons. This report includes the guidelines developed by the Panel regarding the use of laboratory testing in initiating and managing antiretroviral therapy, considerations for initiating therapy, whom to treat, what regimen of antiretroviral agents to use, when to change the antiretroviral regimen, treatment of the acutely HIV-infected person, special considerations in adolescents, and special considerations in pregnant women. Viral load and CD4+ T cell testing should ideally be performed twice before initiating or changing an antiretroviral treatment regimen. All patients who have advanced or symptomatic HIV disease should receive aggressive antiretroviral therapy. Initiation of therapy in the asymptomatic person is more complex and involves consideration of multiple virologic, immunologic, and psychosocial factors. In general, persons who have <500 CD4+ T cells per mm3 should be offered therapy; however, the strength of the recommendation to treat should be based on the patient's willingness to accept therapy as well as the prognosis for AIDS-free survival as determined by the HIV RNA copy per mL of plasma and the CD4+ T cell count. Persons who have >500 CD4+ T cells per mm3 can be observed or can be offered therapy; again, risk of progression to AIDS, as determined by HIV RNA viremia and CD4+ T cell count, should guide the decision to treat. Once the decision to initiate antiretroviral therapy has been made, treatment should be aggressive with the goal of maximal viral suppression. In general, a protease inhibitor and two nucleoside [corrected] reverse transcriptase inhibitors should be used initially. Other regimens may be utilized but are considered less than optimal Many factors, including reappearance of previously undetectable HIV RNA, may indicate treatment failure. Decisions to change therapy and decisions regarding new regimens must be carefully considered; there are minimal clinical data to guide these decisions. Patients with acute HIV infection should probably be administered aggressive antiretroviral therapy; once initiated, duration of treatment is unknown and will likely need to continue for several years, if not for life. Special considerations apply to adolescents and pregnant women and are discussed in detail.
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