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HIV Spotlight on Center on Caring for the Newly Diagnosed Patient

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What's New in the U.S. HIV Clinical Guidelines

February 22, 2019


doctor consulting with a patient

Credit: takasuu for iStock via Thinkstock

U.S. HIV/AIDS medical practice guidelines are updated at periodic intervals to reflect the latest recommendations directed at clinical providers serving persons living with HIV. These federal guidelines, issued by the U.S. Department of Health and Human Services (HHS), are available on AIDSinfo. Each set of guidelines is vetted by a committee of subject matter experts. The experts also consult previous HIV/AIDS medical practice guidelines, recent results from HIV treatment and prevention clinical trials, and new input from providers, researchers, and people living with HIV.

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Due to criticism of the long-form recommendations, the most recent iterations of five key guideline documents were introduced in two formats: a classic "full" version as well as an abbreviated version that may be better suited for the point-of-care setting. The brief versions of these five guideline documents -- Adult and Adolescent Antiretroviral (ARV), Adult and Adolescent Opportunistic Infection (OI), Perinatal, Pediatric ARV, and Pediatric OI -- include modifications and shorter descriptions. The rest of the guidelines are only available in their full iterations.

We briefly summarize recent changes to each of the guidelines below, starting with the most recently updated document.

Adult and Adolescent OI Guidelines

Last updated on Feb. 15, 2019 (brief version; full version).

These guidelines' most recent update eliminated a long-standing recommendation to administer primary prophylaxis for disseminated Mycobacterium avium complex disease (MAC) in all patients with a CD4 count below 50. They now state that primary propylaxis for MAC is not recommended for patients who immediately start antiretroviral therapy for HIV. They also add that primary prophylaxis initiation is only indicated for patients whose antiretroviral therapy is not fully suppressive.

In addition to the prophylaxis adjustments, the updated guidelines also include additional information regarding drug-drug interactions between rifabutin and more recently approved HIV antiretrovirals.

Pediatric OI Guidelines

Last updated on Feb. 8, 2019 (brief version; full version).

A number of minor updates were made to these guidelines in the first two months of 2019. Previously existing sections on Candida infections, isosporiasis (cystoisosporiasis), and Mycobacterium avium complex disease (MAC) were "updated to reflect the new recommendation rating system and references were added," according to the "What's New" section of guidelines document.

Pediatric ARV Guidelines

Last updated on Dec. 14, 2018 (brief version; full version).

The committee states, "Didanosine [ddI, Videx] or stavudine [d4T, Zerit] should never be used as part of an ARV regimen, due to the significant toxicities of these drugs and the availability of safer agents."

The panel made changes to regimens categorized as "preferred" or "alternative" in their respective medication class. In the updates from earlier in 2018, raltegravir (Isentress) and tenofovir alafenamide (TAF) used in combination with emtricitabine (FTC, Emtriva) moved to the preferred category, while Genvoya, tenofovir disoproxil fumarate (Viread, TDF), and zidovudine (AZT, Retrovir) became listed as "alternative."

More specifically, raltegravir became a preferred INSTI regimen from birth to 6 years old.

Genvoya, an FDC tablet that contains elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, is now an alternative regimen for children aged 6 to 12 years and weighing more than 55 pounds. However, Genvoya continues to be a preferred regimen for patients aged at least 12 years old and weighing 77 pounds or more who are not sexually active.

TAF used in combination with emtricitabine is now a preferred NRTI backbone option for children and adolescents older than 6 years who are not sexually active. TAF was previously a preferred option only for those aged 12 years or older.

Tenofovir disoproxil fumarate used in combination with lamivudine or emtricitabine is now considered an alternative NRTI backbone option for children between 2 and 12 years old; the potential risks of decreased bone mineral density should be weighed against the benefits of therapy.

Zidovudine used in combination with lamivudine or emtricitabine was changed from a preferred to an alternative NRTI backbone for children and adolescents older than 6 years who are not sexually active.

Perinatal ARV Guidelines

Last updated on Dec. 7, 2018 (brief version; full version).

The HHS Panel on Antiretroviral Guidelines for Adults and Adolescents updated guidance on the use of dolutegravir in adults and adolescents with HIV who are pregnant or of childbearing potential.

Adult and Adolescent ARV Guidelines

Last updated on Oct. 25, 2018 (brief version; full version).

This clinical guideline was most recently updated to provide guidance for clinicians on several issues, including the following:

  • Resistance testing. The experts have updated the guideline with some details on the benefits and limitations of various HIV-1 proviral DNA genotypic resistance tests, especially when a patient has low-levels of viremia.
  • Co-receptor tropism testing. The panel now recommends using a proviral DNA tropism assay to assess co-receptor usage before maraviroc (Selzentry, Celsentri) is initiated as part of a new regimen for patients who have undetectable HIV RNA.
  • Virologic failure options in treatment-experienced patients. This section was updated with information for clinicians on new treatment options that may be viable options for patients who are experiencing first-line treatment failure, as well as using the newly approved ibalizumab (Trogarzo) for patients with multidrug-resistant HIV.
  • Optimizing ART in the setting of viral suppression. This section reflects the panel’s recommendations on how best to determine how to change regimens for people who have achieved viral suppression, including people who are pregnant.
  • Guidance on the use of dolutegravir (Tivicay, DTG) in people who are pregnant. This section was updated to provide guidance for clinicians who are considering prescribing dolutegravir or other integrase strand transfer inhibitors (INSTIs) in persons who are pregnant; express plans to get pregnant; or are heterosexually active, of childbearing potential, and not using any form of birth control or contraception.
  • Newly approved ARV regimens. New guidelines were added for using several newly approved ARVs, including:
    • Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy, B/F/TAF)
    • Elvitegravir/cobicistat/emtricitabine with tenofovir alafenamide or tenofovir disoproxil fumarate (Genvoya, EVG/c/FTC/TAF or Stribild, EVG/c/FTC/TDF)
    • Doravirine (Pifeltro)
    • Dolutegravir plus lamivudine (DTG plus 3TC, Epivir)

The fourth section, titled, "Exposure-Response Relationship and Therapeutic Drug Monitoring," was removed.

Caring for Persons with HIV Who Have Been Displaced by Disasters

Last updated on Sept. 14, 2018 (full version only).

The recommendations reflect three central principles during a natural disaster such as a hurricane: ARVs should be available for all regardless of CD4 count, and interruptions in ARVs should be avoided or kept at a minimum. If a patient reports successful ARV use without side effects, their treatment regimen should continue with as little disruption as possible. Practical application may look like having web-based resources available and devising adherence management strategies with each patient prior to a disaster.

Occupational Post-Exposure Prophylaxis (PEP)

Last updated on May 23, 2018 (full version only).

An interim statement was attached to the guidelines stating that the use of dolutegravir should be avoided in adults and adolescents who are pregnant or of childbearing potential. The preferred PEP regimen in these cases is raltegravir, tenofovir, and emtricitabine.

Non-Occupational Post-Exposure Prophylaxis

Last updated on May 23, 2018 (full version only).

An interim statement was attached to the guidelines stating that the use of dolutegravir should be avoided in adults and adolescents who are pregnant or of childbearing potential. The preferred PEP regimen in these cases is raltegravir, tenofovir, and emtricitabine.

Laboratory Testing

Last updated in January 2018.

Although the core recommendations have not been updated since 2014, a series of technical updates have been issued in subsequent years. The most recent is a January 2018 "quick reference guide" on the recommended algorithm for conducting HIV testing of serum and plasma specimens.

Pre-Exposure Prophylaxis

This document has not been revised since a "2017 Update" version was published online in March 2018.

Prevention With Persons With HIV

This document has not been updated since Dec. 30, 2016.

Hormonal Contraception

This document has not been updated since June 22, 2012.

HIV Counseling, Testing, and Referral

This document has not been updated since Sept. 22, 2006.

Stephen Hicks is a writer and public health advocate with a background in sexual health and harm reduction. He is based in Washington, D.C.

Myles Helfand is the executive editor and general manager of TheBody.com and TheBodyPRO.com. Follow Myles on Twitter: @MylesatTheBody.


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