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Among New HIV Treatment Recommendations, All Adult HIV Patients Should Be Offered Antiretroviral Therapy, Regardless of CD4 Cell Count

EMBARGOED FOR EARLY RELEASE: 10 A.M. (ET) SUNDAY, JULY 22, 2012

Media Advisory: To contact Melanie A. Thompson, M.D., email drmt@mindspring.com, or contact Donna Jacobsen, Executive Director of IAS-USA at DJacobsen@iasusa.org or 415-544-9400.


WASHINGTON, D.C. – Included in the 2012 International Antiviral Society-USA panel recommendations for human immunodeficiency virus (HIV) patient care is that all adult patients, regardless of CD4 cell count, should be offered antiretroviral therapy (ART), according to an article in the July 25 issue of JAMA, a theme issue on HIV/AIDS. Other new recommendations include changes in therapeutic options and modifications in the timing and choice of ART for patients with an opportunistic illness such as tuberculosis.

Melanie A. Thompson, M.D., of the AIDS Research Consortium of Atlanta, presented the findings of the article at a JAMA media briefing at the International AIDS Conference.

“Since the first antiretroviral drug was approved 25 years ago, improvements in the potency, tolerability, simplicity, and availability of ART have resulted in dramatically reduced numbers of opportunistic diseases and deaths where ART is accessible,” according to background information in the article. “New trial data and drug regimens that have become available in the last 2 years warrant an update to guidelines for ART in HIV-infected adults in resource-rich settings.”

Dr. Thompson and colleagues with the International Antiviral Society-USA panel conducted a review of the medical literature to identify relevant evidence published since the last report (2010), as well as data that had been published or presented in abstract form at scientific conferences in the past 2 years. The revised guidelines reflect new data regarding recommendations of when to initiate ART, new options for initial and subsequent therapy, ART management in the setting of special conditions, new approaches to monitoring treatment success and quality, and managing antiretroviral failure.

Among the primary recommendations of the panel are that treatment is recommended for all adults with HIV infection. The researchers found that there is no CD4 cell count threshold at which starting therapy is contraindicated, but the strength of the recommendation and the quality of the evidence supporting initiation of therapy increase as the CD4 cell count decreases and when certain concurrent conditions are present. Patients should be monitored for their CD4 cell count, and also HIV-1 RNA levels, ART adherence, HIV drug resistance, and quality-of-care indicators.

Initial regimens that are recommended include 2 nucleoside reverse transcriptase inhibitors (tenofovir/emtricitabine or abacavir/lamivudine) plus a nonnucleoside reverse transcriptase inhibitor (efavirenz), a ritonavir-boosted protease inhibitor (atazanavir or darunavir), or an integrase strand transfer inhibitor (raltegravir). “The aim of therapy continues to be maximal, lifelong, and continuous suppression of HIV replication to prevent emergence of resistance, facilitate optimal immune recovery, and improve health” the authors write. Alternatives in each class are recommended for patients with or at risk of certain concurrent conditions, including cardiovascular disease, reduced kidney function, or tuberculosis.

The primary reasons for switching regimens include virologic, immunologic, or clinical failure and drug toxicity or intolerance. Switching regimens in virologically suppressed patients to reduce toxicity, improve adherence and tolerability, and avoid drug interactions can be done by switching 1 or more agents in the regimen. “Confirmed treatment failure should be addressed promptly and multiple factors considered,” the researchers write.

“Although it is crucial to intensify efforts to find a cure for persons who are already infected and an effective vaccine for those who are not, many of the tools needed to control the HIV/AIDS pandemic are already at hand. Critical components of the tool kit to eradicate AIDS include expanded HIV testing, increased focus on engagement in HIV care, early and persistent access to ART, and attention to improving ART adherence. These must occur in the context of strategies to address social determinants of health, including the elimination of stigma and discrimination,” the authors conclude.

(JAMA. 2012;308[4]:387-402. Available pre-embargo to the media at http://media.jamanetwork.com)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.