Updated U.S. DHHS Guidelines for Treatment of Adults and Adolescents with HIV

An updated version of the U.S. Department of Health and Human Services (DHHS) Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents has been released.

The latest revision, dated December 1, 2007, includes new information on:

• Lab tests during the initial clinic visit for newly diagnosed patients;
• Updated recommendations on when to start antiretroviral treatment;
• Management of treatment-experienced patients, including suggestions on use of the recently FDA-approved entry inhibitor (CCR5 antagonist) maraviroc (Selzentry/Celsentri) and integrase inhibitor raltegravir (Isentress).

Changes to the guidelines are summarized in the "What's New in the Document?" section located at the front of the guidelines. The changes are also highlighted in yellow throughout the text and tables.

Following are the specific changes to this latest edition of the guidelines, made since the previous revision dated October 10, 2006. Additional revisions to other sections of the guidelines will be released in 2008.

The strength of the recommendations is included in parentheses, with “A” indicating the strongest recommendation, “C” indicating optional, and “E” indicating never recommended; the quality of scientific evidence supporting the recommendations is ranked from I (at least 1 randomized clinical trial) to III (expert opinion).

Laboratory Assessment

• Drug-resistance Testing -- The DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents recommends genotypic drug resistance testing for all treatment-naive patients entering clinical care, regardless of whether they will immediately start antiretroviral therapy (AIII). This recommendation is based on the fact that transmitted drug-resistance mutations may be detected soon after infection. Repeat testing may be considered when therapy is to be initiated (CIII).

• Viral Tropism Assay -- The panel recommends tropism testing prior to the initiation of a CCR5 antagonist, such as maraviroc (AII), to determine which co-receptors a person’s HIV is using; these drugs should only be used by patients with exclusively CCR5-tropic virus. Co-receptor tropism testing might also be considered for patients exhibiting virological failure while taking maraviroc or another CCR5 antagonist (BIII).

• HLA-B*5701 Testing -- The panel recommends HLA-B*5701 testing prior to initiating abacavir (Ziagen) to reduce the risk of hypersensitivity reactions (AI). HLA-B*5701 positive patients should not be given abacavir (AI), and the positive status should be recorded as an abacavir allergy in the patient’s medical record (AII).

When HLA-B*5701 screening is not readily available, it remains reasonable to initiate abacavir with appropriate clinical counseling and monitoring for any signs of abacavir-associated hypersensitivity reactions (CIII).

When to Start Antiretroviral Therapy

• The panel now recommends that antiretroviral therapy should be initiated in patients with history of an AIDS-defining illness or with a CD4 T-cell count < 350 cells/mm³. The data supporting this recommendation are stronger for patients with a CD4 count < 200 cells/mm³ and with a history of AIDS (AI) than for those with CD4 counts between 200 and 350 cells/mm³ (AII). This recommendation is consistent with the latest revision of the European AIDS Clinical Society (EACS) guidelines, presented this past October. 

• The panel also recommends treatment for the following groups regardless of CD4 -cell count:
• Pregnant women (AI);
• Patients with HIV-associated nephropathy (kidney disease) (AI);
• Patients coinfected with hepatitis B virus (HBV) when anti-HBV treatment is indicated (BIII).

• The optimal time to initiate therapy in asymptomatic patients with a CD4 cell count > 350 cells/mm³ is not well defined. The decision about whether or to start treatment in these patients should take into account the potential benefits and risks associated with therapy, co-morbidities, and patient readiness and willingness to adhere to long-term treatment.

Management of Treatment-Experienced Patients

This section was revised to include a review of the newer classes of antiretroviral agents (CCR5 antagonists and integrase inhibitors) and their roles in the management of treatment-experienced patients with virological failure; and a discussion of immunological failure (lack of adequate CD4 cell recovery).

Updated Tables

Various tables in the guidelines have been updated to reflect new recommendations and new information on specific antiretroviral drugs.

Click here to access the complete document: Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. (Revised December 1, 2007).

12/04/07

Source
DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. December 1, 2007).