Updated DHHS Guidelines on HIV Treatment

Last week, the U.S. Department of Health and Human Services (DHHS) and the WHO each released updated versions of their HIV treatment guidelines. Both agencies now endorse prescribing antiretroviral therapy (ART) much earlier in the course of disease than they previously did, and both provide new guidance on which drugs to use. (A complete review of the WHO guidelines, by Dr. Salim Abdool Karim, is available here.)

The DHHS now offers a moderate-to-strong recommendation that asymptomatic patients with CD4 counts between 350 and 500 cells/mm³ be provided lifelong ART. In making this recommendation, the expert panel cites evidence from two large cohort studies showing substantially reduced all-cause mortality in patients who started ART at this CD4-count threshold (JW AIDS Clin Care Apr 17 2009). The panel reports that it was unable to agree on the subject of treating asymptomatic patients with CD4 counts >500 cells/mm³: Half the members believe that such treatment is indicated, based on evidence that it may reduce mortality from non–AIDS-defining conditions, whereas the other half call it “optional” given the still-unknown long-term risks of lifelong ART.

The DHHS has also changed the format of its drug recommendations — from a “one from column A, one from column B” menu to a list of specific regimens. The four “preferred” regimens for treatment-naive, nonpregnant patients are as follows:

• Efavirenz/tenofovir/FTC

• Ritonavir-boosted atazanavir + tenofovir/FTC

• Ritonavir-boosted darunavir + tenofovir/FTC

• Raltegravir + tenofovir/FTC

Other categories of regimens include “alternative regimens” (those that are effective and tolerable but have potential disadvantages compared with preferred regimens) and “acceptable regimens” (those that may be selected for some patients but are less satisfactory than preferred or alternative regimens). A “What Not to Use” section has been substantially updated.

The DHHS guidelines also now say that genotypic testing is the preferred method of determining resistance for most patients, but that phenotypic testing should be added for those with suspected complex mutations and for those who have failed two or more regimens. A new section on managing patients with HIV-2 infection has also been appended.