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Updated Antiretroviral Treatment Guidelines Include Cost Considerations

The U.S. Department of Health and Human Services (DHHS) this week released an update to its Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Among the major changes are the addition of a new section on cost considerations and a recommendation for less frequent CD4 T-cell monitoring for people without advanced disease.

Changes to the guidelines are highlighted in an introductory section, What's New in the Guidelines? Among the key changes in the latest edition:

• New section on Cost Considerations and Antiretroviral Therapy. Past versions did not formally discuss expenses related to antiretroviral therapy (ART), but the new edition includes an overview of costs as they relate to adherence, cost-sharing, prior authorization, and use of generic drugs, with strategies for cost containment that do not compromise treatment effectiveness.
• Change in recommended frequency of CD4 monitoring. The guidelines panel emphasizes that viral load, rather than CD4 count, is the most important measure of response to ART. CD4 count should be assessed when a person initiates care, but after starting ART it is most helpful for people with advanced HIV disease to guide discontinuation of opportunistic infection prophylaxis or treatment. Frequent monitoring is generally not required for people with high CD4 counts and consistent viral load suppression, and the panel now advises that CD4 testing be done annually for people with 300-500 cells/mm³ and is optional for those with >500 cells/mm³. Monitoring of CD8 cells is not clinically useful and not routinely recommended.
• The classification of "Preferred" regimens has been changed to "Recommended," recognizing the expanded range of effective and well-tolerated options. Regimens for people starting ART for the first time are divided into those recommended for all treatment-naive patients regardless of baseline viral load and additional options for people starting with low viral load (<100,000 copies/mL).
• Given the large number of Recommended and Alternative options, several drugs are no longer recommended for first-line therapy, including zidovudine (AZT, Retrovir), nevirapine (Viramune), unboosted atazanavir (Reyataz), boosted fosamprenavir (Lexiva) or saquinavir (Invirase), and maraviroc (Selzentry or Celsentri).
• A new subsection summarizing clinical trial data on first-line ART strategies for people who cannot use either tenofovir (Viread, also in Truvada, Atripla, Complera, and Stribild) or abacavir (Ziagen, also in Epzicom or Kivexa).
• More emphasis on switching antiretrovirals in people with viral suppression. The panel emphasizes that the key principle is maintaining undetectable viral load without compromising future treatment options, and notes that a patient’s prior treatment history, response to ART, resistance profile, and drug tolerance should be considered when contemplating a regimen switch. A new table has been added to guide switching due to adverse events.

The guidelines panel welcomes feedback on the revised recommendations. Comments can be e-mailed to JLIB_HTML_CLOAKING with the subject line "Comments on the Adult and Adolescent ARV Guidelines" by May 16, 2014.

5/2/14

Reference

Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. May 1, 2014.

Other Sources

Aids.gov. Updated HHS Adult and Adolescent Antiretroviral Treatment Guidelines Released. blog.AIDS.gov. May 1, 2014.

R Klein, K Struble, and S Morin, FDA. Revised HHS Adult and Adolescent Antiretroviral Treatment Guidelines available. HIV/AIDS Update. May 1, 2014.