Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
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Food and Drug Administration - October 10, 2006
Richard Klein & Kimberly Struble
On October 10, 2006, the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents released a new revision of the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.
The following are among changes that have been made to the May 4, 2006 version of the guidelines:
* The Panel confirms that the regimens with the most experience in demonstrating virologic and immunologic efficacy are those composed of 1 NNRTI + 2 NRTI or of a PI (with or without ritonavir boosting) + 2 NRTI. The Panel also confirms that the selection of an antiretroviral regimen should be individualized, based on patient- and drug-specific factors.
* The Panel revised its recommendations for preferred and alternative antiretroviral components based on reported results from several randomized trials in treatment-naïve patients and on safety data that have emerged since the last revision. Specific recommendations can be found in Tables 6a (Antiretroviral Components Recommended for Treatment of HIV-1 Infection in Treatment Naïve Patients) and 6b (Antiretroviral Components That Are Acceptable as Initial Antiretroviral Components but Are Inferior to Preferred or Alternative Components). Rationale for the recommendations is outlined in the text.
The following tables have been updated:
* Table 6 has been revised and divided into Tables 6a and 6b to reflect the above revisions.
* Tables 7 and 9 have been updated to reflect changes in the recommendations.
* Table 10 has been updated with results from several recently published clinical trials.
* Tables 11-13, 15, and 17-19 have been updated to include information regarding darunavir and the fixed-dose combination of efavirenz/emtricitabine/ tenofovir (Atripla(tm)) and new safety information and black box warnings regarding rare cases of intracranial hemorrhages occurring in patients receiving tipranavir.
* Tables 20-22b have been updated to include darunavir drug-drug interactions.
* Tables 28 and 29 have been revised according to updates in the Perinatal Guidelines to incorporate preclinical and clinical data relevant to the use of darunavir during pregnancy and new recommendations on antiretroviral use during pregnancy.
* Table 30 has been updated to include information on expanded access programs for two investigational agents, TMC125 and MK-0518.
The complete October 10, 2006, version of the adult treatment guidelines is available here, www.aegis.org/files/fda/2006/FD061010AdultGL.pdf, and on the AIDSinfo web site at http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Changes will be found highlighted in yellow.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
SOURCE: Food and Drug Administration (FDA).
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