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You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.
Please do not reply to this message.
On November 3, 2008, the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents released a revised version of the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.
The following changes have been made to the January 29, 2008 version of the guidelines. Key new updates are highlighted throughout the posted document (see below).
Format Changes
This revision is developed under a new format, whereby the relevant tables and references for each section are incorporated into the body of the document. Some larger tables are placed in an appendix at the end of the document. A separate PDF file with all the tables can be found at the AIDSinfo Web site.
Rating Changes
A new rating scheme is used in this guideline to be more consistent with other guidelines in infectious diseases. The changes are outlined below:
Strength of Recommendations
The D (should usually not be offered) and E (should never be offered) ratings have been removed. The A, B, and C ratings rate the strength of the statement. For example, an A rating for “not to initiate nevirapine in women with pre-treatment CD4 cell count >250 cells/mm3” indicates a strong recommendation to not initiate nevirapine in these patients.
Quality of Evidence
Previously, only randomized trials with clinical endpoints were given a I ranking. In this new rating scheme, a I ranking includes randomized trials with either clinical or validated laboratory outcomes (e.g., viral load). A II rating includes non-randomized trials or well-designed observational cohort studies with long term clinical outcomes. A III rating remains a recommendation based on expert opinion.
Content Changes
The key changes to the different sections of the guidelines are outlined below:
Laboratory Monitoring
Dual-NRTI Options:
The complete November 3, 2008 version of the adult treatment guidelines is available on the AIDSinfo web site at http://aidsinfo.nih.gov/Guidelines/GuidelineDetail.aspx?MenuItem=Guidelines&Search=Off&GuidelineID=7&ClassID=1
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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