New US guidelines strengthen recommendation for ART irrespective of CD4 count (January 2016)

Simon Collins, HIV i-Base

US DHHS guidelines cover

On 29 January 2016, the leading US HIV treatment guidelines were updated online, strengthening the recommendation for early treatment. [1]

The main change is a stronger rating for using ART irrespective of CD4 count; increased to the highest A1 (strongest recommendation based on highest quality of scientific evidence). This change was based on results from the START and TEMPRANO studies. [2. 3]

The recommendations are similarly strengthened (also to A1) for people diagnosed in early infection, noting “earlier ART initiation may result in less residual immune dysfunction during treatment, which theoretically may result in reduced risk of disease for decades to come”.

While recognising some circumstances where treatment might be deferred, the guidelines broadly view access to treatment as an essential right for all HIV positive people, irrespective of mental health, substance use and psychological issues.

The main recommendations are listed below.

  • ART is recommended for all HIV positive individuals, regardless of CD4 cell count, to reduce the
    morbidity and mortality associated with HIV infection (AI).
  • ART is also recommended for HIV positive individuals to prevent HIV transmission (AI).
  • When initiating ART, it is important to educate patients on the benefits and considerations regarding ART, and to address strategies to optimize adherence. On a case-by-case basis, ART may be deferred because of clinical and/or psychosocial factors, but therapy should be initiated as soon as possible.
  • Antiretroviral therapy (ART) is recommended for all individuals with HIV-1 infection (AI) including those with early HIV-1 infection.
  • ART is especially important for older patients because they have a greater risk of serious non-AIDS complications and potentially a blunted immunologic response to ART.
  • The fixed-dose combination of elvitegravir/cobicistat/tenofovir alafenamide/FTC is included as a new preferred first-line option.


  1. US Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. January 2016. (PDF download)
  2. The INSIGHT START Study Group. Initiation of antiretroviral therapy in early asymptomatic infection. NEJM (20 July 2015). DOI: 10.1056/NEJMoa1506816.
  3. The TEMPRANO ANRS 12136 Study Group. A trial of early antiretrovirals and isoniazid preventive therapy in Africa. N Engl J Med 2015; 373:808-822. (27 August 2015). DOI: 10.1056/NEJMoa1507198.

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