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HHS updates antiretroviral guidelines
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The Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents has released updated guidelines for antiretroviral use in adults and adolescents.
In a statement about the update, officials with HHS began by urging the development of protocols and patient participation in clinical trials for HIV medications. The panel’s recommendations affected a few areas of HIV management, including CD4 T-cell testing, drug-resistance testing, ART changes and tuberculosis coinfection.
CD4 T-cell testing
HHS now recommends that a person who is taking HIV medication and has a CD4 count “well above the threshold for opportunistic infection risk” can safely get a new CD4 count every 6 to 12 months instead of the usual 3- to 6-month period, which could mean fewer tests and cost for the patient and physician. However, the panel noted, if there are changes in the patient’s clinical status, such as new HIV-associated clinical symptoms or initiation of treatment with interferon, corticosteroids or antineoplastic agents, testing should continue.
Drug-resistance testing
The panel provides more specific recommendations on when to use genotypic testing to detect resistance to integrase strand transfer inhibitors (INSTIs), noting:
“Because standard genotypic drug-resistance testing involves testing for mutations in the reverse transcriptase (RT) and protease (PR) genes, if transmitted INSTI resistance is a concern, providers may wish to supplement standard genotypic resistance testing with genotypic testing for resistance to this class of drugs.”
ART changes
The recent approval of maraviroc (Selzentry, ViiV Healthcare) combined with zidovudine/lamivudine (ZDV/3TC) prompted the HHS to list this as an “acceptable regimen.” The panel also noted that maraviroc combined with tenofovir/emtricitabine (TDF/FTC) or abacavir (ABC)/3TC may be “acceptable, but more definitive data are needed.” Regimens that include saquinavir boosted with ritonavir are now listed as regimens that “may be acceptable but should be used with caution” because of data released recently that show prolonged PR and QT intervals with this combination. Also in this update, HHS officials have added a new table format, which provides clinicians with a list of the most common and/or severe known antiretroviral-associated adverse events listed by drug class.
TB coinfection
The panel also recommended more aggressive HIV treatment for people who have both TB and HIV, but who have not yet begun their antiretroviral regimens. This updated guideline recommends that patients who are coinfected should begin HIV medications within 2 to 4 weeks after starting TB treatment if their CD4 count is 500 or less, and within 8 weeks of TB treatment if it is more than 500.
The updated guidelines can be viewed and downloaded at http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
The updated HHS guidelines address several issues of practical relevance to front-line HIV care providers. Decreasing the frequency of monitoring CD4+ T cell counts in HIV-infected individuals with high CD4+ T cell counts makes good sense. This will result in cost savings and is consonant with the zeitgeist of health care reform. New recommendations to 'consider' testing for integrase inhibitor resistance in antiretroviral naive individuals are not surprising. Historically, as new antiretroviral drugs have been introduced into practice, drug resistance has become increasingly prevalent resulting in transmission of drug resistant virus. In the case of raltegravir, which has a low mutational barrier and is rapidly gaining a foothold in standard practice, it is only a matter of time before primary drug resistance will emerge as a significant problem. Thus, within a few years the recommendations will undoubtedly evolve from 'considering' testing for integrase inhibitor resistance to routinely testing for this resistance.
–Elizabeth Connick, MD
Infectious Disease News Editorial Board member
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