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On December 1, 2007, the U.S. Department of Health and Human Services released updated guidelines for the treatment of HIV-infected patients. Prompted by the availability of new drugs, as well as new data from clinical trials and cohort studies, the DHHS now recommends more-widespread use of resistance testing, earlier initiation of antiretroviral therapy, and use of human leukocyte antigen (HLA) B*5701 testing before abacavir use. Specific recommendations are as follows:
Drug resistance testing is now recommended for all HIV-infected patients at the time they enter into care, regardless of when they will start treatment. For patients who do not start therapy immediately, repeat testing may be considered when treatment is initiated. These recommendations are based on the fact that, in the absence of therapy, resistant viruses may decline to undetectable levels but still increase the risk for treatment failure when therapy is eventually initiated.
Viral tropism testing is recommended whenever maraviroc use is being considered.
HLA B*5701 testing is recommended whenever abacavir use is being considered, so as to reduce the incidence of hypersensitivity reactions. Patients who test positive for the allele should not receive abacavir.
For asymptomatic patients, antiretroviral therapy should be initiated when CD4 counts fall below 350 cells/mm3. In certain groups of patients, treatment should be initiated regardless of CD4-cell count; these groups include pregnant women, patients with HIV-associated nephropathy, and patients coinfected with hepatitis B virus (HBV) for whom anti-HBV therapy is indicated.
Notably, these new guidelines are similar to those of the European AIDS Clinical Society (EACS), which were released just a few weeks before the DHHS guidelines. A major difference is that the EACS guidelines include new recommendations on which antiretrovirals to use for initial treatment, whereas the DHHS does not plan to release new recommendations on this topic until 2008. The EACS guidelines have downgraded AZT/3TC to an “alternative” nucleoside combination, leaving tenofovir/FTC and abacavir/3TC as “recommended” combinations. Also, the EACS guidelines consider ritonavir-boosted atazanavir to be an “alternative” PI, noting that the drug, although approved by the FDA for initial treatment, is not approved for this purpose by the European Medicines Agency.