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New HIV treatment guidelines recommend return to “hit hard, hit early” strategy

Posted Dec 03 2009 2:10pm
On December 1, the US Department of Health and Human Services (DHHS) issued new guidelines for antiretroviral therapy (ART) in adults and adolescents.  The DHHS guidelines mark a shift back toward the “hit hard, hit early” ART approach that prevailed in the late 1990s.

The main highlights of the revised guidelines are listed below. (To read the new guidelines in their entirety, visit AIDS Action Committee’s HIV Health Library “Guidelines” web page, and click on the link for “Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents” in the HIV Treatment Guidelines section.)

  • HIV-infected persons with CD4 counts of 500 of less are now recommended to start antiretroviral therapy (ART).  With few exceptions, the previous guidelines recommended that ART be started when people’s CD4 counts were below 350.
  • People with the following conditions are recommended to start treatment, regardless of their CD4 count:  pregnancy, HIV-associated nephropathy (kidney disease), and hepatitis B virus (HBV) coinfection when HBV treatment is indicated.
  • The expert panel responsible for the guidelines was split on whether persons with CD4 counts above 500 should start ART.  Half favored starting ART in this situation, while the other half felt that ART should be optional in this situation (more detail below).
  • The new guidelines provide more specific recommendations on when to use particular types of resistance tests.  Genotypic resistance testing is recommended for most situations, while phenotypic resistance testing is recommended for use in persons infected with HIV with known or suspected complex resistance mutation patterns, particularly mutations involving protease inhibitor drugs.
  • There was one addition to the list of preferred regimens for people starting ART for the first time: raltegravir + tenofovir/emtricitabine (better known by their trade names: Isentress + Truvada).
  • Lopinavir/ritonavir (trade name Kaletra)-based regimens have been demoted from “preferred” to “alternative” for most persons starting ART.  An exception is pregnant women for whom Kaletra + Combivir remains a preferred regimen.


Taking into account the above changes, the four preferred ART options for most people starting ART are now: 

  1. efavirenz/tenofovir/emtricitabine (trade name Atripla);
  2. ritonavir-boosted atazanavir + tenofovir/emtricitabine (trade names Norvir + Reyataz + Truvada);
  3. ritonavir-boosted darunavir + tenofovir/emtricitabine (trade names Norvir + Prezista + Truvada);
  4. and raltegravir + tenofovir/emtricitabine (Isentress + Truvada).

In my opinion, the recommendation to start treatment earlier (CD4 counts of 500 or less) and the debate over whether to start treatment at CD4 counts over 500 are the most newsworthy aspects of the new guidelines.  The rationale for the debate is explained in the following paragraphs taken from the guidelines:

“Panel members favoring earlier initiation of therapy [at CD4 counts over 500] base their recommendation on several recent developments:

  1. Report from at least one recent cohort study demonstrating survival benefit with initiation of antiretroviral therapy at CD4 count >500 cells/mm3;
  2. Growing awareness that untreated HIV infection may be associated with development of many non-AIDS-defining diseases, including cardiovascular disease, kidney disease, liver disease, and malignancy;
  3. Availability of antiretroviral regimens that are more effective, more convenient, and better tolerated than antiretroviral combinations no longer in use;
  4. And increasing evidence that effective antiretroviral therapy reduces HIV transmission.

The other 50% of the Panel members feel that current evidence does not definitively demonstrate clear benefit of antiretroviral therapy in all patients with CD4 count >500 cells/mm3. They also feel that risks of short- or long-term drug-related complications, nonadherence to lifelong therapy in asymptomatic patients, and potential for development of drug resistance may offset possible benefits of earlier initiation of therapy. Thus, pending more definitive supporting evidence, these panel members recommend that therapy in this setting should be optional and considered on a case-by-case basis.”

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