HHS Panel Updates ART Use Guidelines

The US Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents has released an updated version of its recommendations. The revision features a new section on transgender people living with HIV, a rewritten section on substance use and disorders, and update to the HIV-2 infection section.

Transgender People With HIV:

For the first time, the panel has included a section on the recommended use of antiretrovirals among transgender and nonbinary individuals. These populations are particularly vulnerable to HIV and recent estimates indicate that 14% of transgender women are living with HIV and 2% of transgender of men have HIV.

As such, the panel recommends antiretroviral therapy (ART) for all transgender individuals living with HIV. Additionally, HIV care services should be made available within a gender-affirmative care model in order to mitigate potential barriers to treatment adherence, as well as maximize the likelihood of achieving viral suppression.

The panel’s recommendations also note that some antiretroviral drugs may have pharmacokinetic interactions with gender-affirming therapy, and that clinical effects and hormone levels should be routinely monitored. Additionally, the panel reminds clinicians that these hormone therapies are linked to hyperlipidemia, elevated cardiovascular risk, and osteopenia and, therefore, it is important to select an ART regimen that will not increase the risk of these adverse events.

Substance Use Disorders and HIV:

The panel notes that substance use disorders (SUDs) are prevalent among people living with HIV and can contribute to poor health outcomes and, therefore, recommends that screening for SUDs should be a part of routine clinical care.

Continuous substance use should not be considered a contraindication to ART, and the panel indicates that all individuals who use substances can achieve and maintain viral suppression by taking ART.

However, when selecting an ART regimen, providers should be cognizant of potential adherence barriers or comorbidities associated with addiction that could impact care, including potential drug-drug interactions and adverse events associated with the medications being taken.

Providers should also offer all patients with HIV and SUDs evidence-based pharmacotherapy such as tobacco cessation treatment, opioid agonist therapy, etc., as part of HIV care.

Finally, providers should note that once-daily single tablet regimens with high barriers to resistance, low hepatotoxicity, and low potential for drug-drug interactions are preferred for this population of individuals.

HIV-2 Infection:

The guidelines on treating patients with HIV-2 infections have been revised by the panel with updated recommendations on initiation of ART and which regimens to use among patients with mono-infection of HIV-2 or coinfection with HIV-1 and HIV-2.

Previously, it was recommended that individuals with HIV-2 begin ART before clinical progression. Existing data on the treatment of HIV-2 and extrapolation from data on the treatment of HIV-1 suggest that ART should be initiated at or soon after diagnosis to prevent disease progression and transmission.

The panel notes that no randomized controlled trials have determined which treatment regimens are the most effective for treating patients with HIV-2, but highlights that 2 single-arm clinical trials have shown “favorable outcomes” in patients receiving integrase strand transfer inhibitor (INSTI)-based regimens.

Based on this information, the panel recommends the use of an INSTI-based regimen as an initial ART regimen when treating patients with no previous treatment history with HIV-2. Alternatively, a regimen that includes a boosted protease inhibitor that is active against HIV-2, such as darunavir or lopinavir, can be used.

Revisions to additional sections are expected to be released later this year.