U.S. Antiretroviral Therapy Guidelines

NOTE: The full text of these guidelines is available on the Internet.

Table of Contents

Why Do the Guidelines Keep Changing?

We keep learning more about the best way to fight HIV. In 1998, the US Department of Health and Human Services created a panel of physicians, researchers, and consumers to develop treatment guidelines. They constantly review AIDS research results. The guidelines are updated at least once each year. This fact sheet reflects the guidelines as of April 2016.

NOTE: These are guidelines, not rules. Patients should receive individualized care from a health care provider with experience treating HIV infection. The full text of these guidelines is available on the Internet at http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf

Viral Load and CD4 Cell Testing

Viral load and CD4 cell tests provide critical information for decisions on antiretroviral therapy (ART). Before changing treatment, the tests should be repeated to confirm the results. Fact Sheet 124 has more information on CD4 cell tests and Fact Sheet 125 covers viral load testing.

Resistance Testing

Viral resistance testing helps health care providers choose the most effective drugs. See Fact Sheet 126 for more information. Resistance testing is recommended for patients starting therapy, when viral load is not controlled by new medications, or when it "breaks through" a regimen that used to work. The guidelines recommend resistance testing before starting ART. This can show if the person got infected with drug-resistant virus

Other Laboratory Tests

The guidelines recommend using a viral tropism test (see fact sheet 129) before starting therapy with a CCR5 inhibitor. They also suggest using a genetic test, HLA-B*5701 before starting abacavir (see fact sheet 416),

When to Start Treatment

Treatment is recommended for all people living with HIV, regardless of CD4 count.

Regardless of CD4 count, treatment is strongly recommended for all pregnant patients, and patients with HIV-associated nephropathy (a kidney disorder) or those who need treatment for hepatitis B.

Goals of Therapy

The guidelines list the following goals for HIV therapy. Treatment goals are the same for people starting therapy and those who have been on therapy for a long time:

  • Reduce viral load as much as possible for as long as possible
  • Restore or preserve the immune system
  • Reduce sickness and death due to HIV
  • Prolong the duration and quality of life
  • Prevent HIV transmission

The following tools are suggested to help achieve these goals:

  • Selection of initial ART
  • Maximize adherence. Help the patient take medications correctly.

What Drugs Should Be Used First?

The guidelines recommended 6 ART regimens for people starting anti-HIV treatment.

Five of the six regimens use a HIV integrase inhibitor with two nukes:

One regimen uses a protease inhibitor with two nukes:

Several other combinations are categorized as "alternative" or "other" regimens, including previously recommended Atripla, Complera and atazanavir (Reyataz). These regimens have possible disadvantages compared with the recommended regimens or have less study data.

Factors to Consider in Choosing Initial ART

The guidelines recommend considering pre-treatment

  • Viral load
  • CD4 count
  • HIV resistance test results
  • HLA-B*5701 status
  • Patient preferences and anticipated adherence

Selection should also consider the patient's

  • Cardiovascular disease
  • Kidney and bone disease
  • Mental health
  • Neurologic disease
  • Drug addiction treatment
  • Pregnancy or pregnancy potential
  • Co-infection with hepatitis B virus, hepatitis C virus and tuberculosis

ART Adherence

Taking ART correctly, every day, is critical for the medications to work; this is called adherence. The guidelines recommend involving the patient in ART selection, to assess adherence at every clinic visit, to identify the type and reasons for non-adherence.

Other Parts of the Guidelines?

The guidelines also discuss virologic failure, poor CD4 recovery, regimen switching and the discontinuation or interruption of treatment.