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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

December 20, 2018


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Credit: takasuu for iStock via Thinkstock

HIV/AIDS medical practice guidelines are updated at various intervals to reflect the 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 committees of subject matter experts. The experts also consult previous HIV/AIDS medical practice guidelines and HIV treatment and prevention clinical trials, along with evaluating current input from providers, researchers, and people living with HIV.

Due to criticism of the long-form recommendations, the most recent five guidelines were introduced in abbreviated fashion, which may be better suited for the point-of-care setting. These specific guidelines -- Adult and Adolescent Antiretroviral (ARV), Adult and Adolescent Opportunistic Infection (OI), Perinatal, Pediatric ARV, and Pediatric OI guidelines -- include modifications and shorter descriptions. The rest of the guidelines are only available in their full iterations.

Adult and Adolescent ARV Guidelines

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Last updated October 2018: This clinical guideline was 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.

Adult and Adolescent OI Guidelines

Last updated November 2018: This update recommends using the human papillomavirus disease (HPV) vaccine in persons aged 13 to 26 years, rather than the 9-valent HPV recombinant vaccine (0.5 mL at 0, 1 to 2, and 6 months). For patients who have completed a vaccination series with the recombinant bivalent or quadrivalent vaccines, this committee recommends providing an additional full series of the 9-valent recombinant vaccine.

The recommendation included information regarding the recently approved two-dose hepatitis B vaccine conjugated to a TLR9 agonist (Heplisav-B). At this time, there is no data on how this vaccine affects persons living with HIV.

Perinatal ARV Guidelines

Last updated December 2018: 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.

Pediatric ARV Guidelines

Last updated May 2018: 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.

Pediatric OI Guidelines

Last updated July 2018: Live-attenuated influenza vaccine is not recommended, because of decreased effectiveness.

Guidance for Non-HIV-Specialized Providers Caring for Persons with HIV Who Have Been Displaced by Disasters

Last updated September 2018: 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.

Pre-Exposure Prophylaxis

No changes were made to recommendations from the 2016 update.

Occupational Post-Exposure Prophylaxis (PEP)

Last updated May 2018: 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 May 2018: 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.

Prevention With Persons With HIV

No changes were made to recommendations from the 2014 update.

Laboratory Testing

Last updated January 2018: The HIV testing algorithm was updated here. The antigen/antibody immunoassay detects HIV-1 and HIV-2 antibodies and HIV-1 p24 antigen to test for established HIV-1 and HIV-2 infection and for acute HIV-1 infection.

Hormonal Contraception

No changes were made to recommendations from the 2012 update.

HIV Counseling, Testing, and Referral

No changes were made to recommendations from the 2006 update.

TheBodyPRO will continue provide updates for the HIV/AIDS medical practice guidelines. The guidelines are available in full at AIDSInfo.

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.


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