Food and Drug Administration - December 5, 2007
Richard Klein & Kimberly Struble

Laboratory Assessment

• Drug Resistance Testing - The Panel recommends performing genotypic drug resistance testing for all treatment-naïve patients entering into clinical care, regardless of whether antiretroviral therapy is to be initiated (AIII). This recommendation is based on the fact that transmitted resistance mutation may be detected at a time point more proximal to the time of infection than later. Repeat testing may be considered at the time when therapy is to be initiated (CIII).

• Tropism Assay - The Panel recommends tropism testing prior to the initiation of a CCR5 antagonist, such as maraviroc (AII). Coreceptor tropism testing might also be considered for patients exhibiting virologic failure on maraviroc (or any CCR5 inhibitor) (BIII).

• HLA-B*5701 Testing - The Panel recommends HLA-B*5701 testing prior to initiating abacavir therapy to reduce the risk of hypersensitivity reaction (AI). HLA-B*5701-positive patients should not be prescribed 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 ABC with appropriate clinical counselling and monitoring for any signs of abacavir-associated hypersensitivity reaction (CIII).

When to Start Antiretroviral Therapy

1. The Panel 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 those with a CD4 T-cell count <200 cells/mm3 and with a history of AIDS (AI) than for those with CD4 T-cell counts between 200 and 350 cells/mm3 (AII).

2. The Panel also recommends treatment for the following groups regardless of CD4 T-cell count:

a) pregnant patients (AI);
b) patients with HIV associated nephropathy (AI);
c) patients coinfected with hepatitis B when treatment for hepatitis B virus is indicated (BIII).

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

Management of Treatment-Experienced Patients

This section was revised to include (1) 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 virologic failure; and (2) a discussion of immunologic failure.

Tables Update

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

The complete December 1, 2007 version of the adult treatment guidelines is available on the AIDSinfo web site at http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

071205
FD071201

SOURCE: Food and Drug Administration (FDA).

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, the National Library of Medicine, Roche and Trimeris, and donations from users like you. Always watch for outdated information. This article first appeared in 2007. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2007. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .