What's New in the Guidelines

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Reviewed
Sep. 21, 2022

September 21, 2022

Selection of Antiretroviral Therapy for Individuals Who Acquire HIV After Having Received Long-Acting Cabotegravir for Pre-Exposure Prophylaxis

In this update, several sections of the guidelines have been revised with discussions on factors that clinicians should consider when selecting an antiretroviral (ARV) regimen for individuals who acquire HIV after having received long-acting cabotegravir (CAB-LA) for HIV pre-exposure prophylaxis (PrEP). Because of the long half-life of CAB-LA, the Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) recommends performing genotypic resistance testing, including testing for integrase resistance, before starting antiretroviral therapy (ART). If resistance testing results are not available before ART initiation, the Panel recommends initiating a boosted darunavir regimen while awaiting results confirming no resistance to the integrase strand transfer inhibitor (INSTI) drug class. The sections updated with this new information include the following:

Dolutegravir and Neural Tube Defects

Previously, the Tsepamo study from Botswana reported a higher prevalence of neural tube defects (NTDs) in women who received dolutegravir (DTG) during conception than with other ARV drugs. An updated report from the same study showed that the prevalence of NTDs is not significantly different from those on non-DTG regimens. For persons of childbearing potential who are trying to conceive, DTG-based regimens are among the recommended options for most individuals initiating ART. The following sections have been updated with this new information:

Laboratory Testing

The Panel updated the following sections relating to laboratory tests to be done at the time of ART initiation and the frequency of monitoring during follow-up:

Drug-Resistance Testing

This section has been updated with two key new recommendations:

  • The Panel now recommends drug-resistance testing for people with virologic failure and HIV-RNA levels >200 copies/mL (AI for >1,000 copies/mL, AIII for 501–‍1,000 copies/mL, CIII for confirmed HIV RNA 201–500 copies/mL). For people with confirmed HIV-RNA levels >200 copies/mL but <500 copies/mL, drug-resistance testing may be unsuccessful but should still be considered.
  • The Panel previously recommended that resistance testing should be done within 4 weeks of discontinuation of an ARV regimen. However, given the long half-lives of the long-acting injectable ARV drugs, resistance testing (including testing for resistance to INSTIs) should be performed in all persons who have experienced virologic failure on a regimen of long-acting cabotegravir and rilpivirine (RPV) or acquired HIV after receiving CAB-LA as PrEP, regardless of the amount of time since drug discontinuation (AIII).
     

Optimizing Antiretroviral Therapy in the Setting of Viral Suppression

This section has been revised with the following key updates:

  • The Panel recommends that for regimen optimization in the setting of existing nucleoside reverse transcriptase inhibitor (NRTI) resistance, two NRTIs—tenofovir alafenamide or tenofovir disoproxil fumarate plus emtricitabine (FTC) or lamivudine (3TC)—should be included in the regimen with a fully active drug that has a high resistance barrier, such as DTG, boosted darunavir (BIII), or bictegravir (CIII).
  • The Panel recommends that pregnant persons who present to care on CAB-LA and RPV should be switched to a Preferred or an Alternative three-drug ARV regimen recommended for use in pregnancy per the Perinatal Guidelines (AIII).
     

Virologic Failure

This section has been updated to harmonize with the recommendations in the Drug-Resistance Testing section of the guidelines with regard to drug-resistance testing in patients in a failing long-acting ARV regimen and recommendations for resistance testing in patients with HIV viral load >200 copies/mL. The section also added clinical trial data from the DAWNING and NADIA studies, in assessing the roles of an INSTI or boosted protease inhibitor–based regimen in patients with failure to first-line non-nucleoside reverse transcriptase inhibitor–based regimens.
 

Adherence to the Continuum of Care

This section continues to stress the importance of assessing adherence and assisting patients to ensure uninterrupted access to treatment and care. The section also noted that the Panel recommends against the use of the long-acting ART regimen of intramuscular CAB and RPV in people who have detectable viral load due to suboptimal adherence to ART and who have ongoing challenges with retention in HIV care, except in a clinical trial (AIII).
 

Other Updates

Minor updates have been made to the following sections:

September 1, 2022

Drug–Drug Interactions Tables

  • The Panel updated the Drug–Drug Interactions tables (Tables 24af) with guidance on the interaction potentials between antiretroviral drugs and antiviral drugs (brincidofovir, cidofovir, or tecovirimat) that are currently being used to treat monkeypox.
     

January 20, 2022

Early (Acute and Recent) HIV Infection

  • In the previous version of the guidelines, the Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) suggested that an HIV RNA level of <10,000 copies/mL in a person suspected to have acute HIV may represent a false-positive test result. The section was updated to revise this threshold. The Panel noted that given the improved sensitivity and specificity of current HIV RNA tests in the presence of compatible symptoms or exposure history, even a low HIV RNA concentration (e.g., <3,000 copies/mL) in the setting of a negative or indeterminate HIV antibody test result may represent acute HIV. The Panel noted that, in rare cases, an HIV RNA <3,000 copies/mL may represent a false-positive quantitative test result. In that case, repeat testing should be done to confirm the diagnosis.
  • In this revision, the Panel also provided updated information regarding diagnosis of acute HIV in individuals who are receiving pre-exposure prophylaxis and subsequent initiation of antiretroviral therapy (ART).
     

Discontinuation or Interruption of Antiretroviral Therapy

  • This section has been updated to include discussions regarding discontinuation or interruption of long-acting antiretroviral drugs, including ibalizumab and the intramuscular formulations of cabotegravir and rilpivirine. The section also includes discussions regarding steps to take before and during ART interruption for people with HIV who participate in clinical trials that involve analytical treatment interruptions.

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