Updated US guidelines: TAF in, Cabenuva out for pregnant people

On December 30, the Department of Health and Human Services updated its HIV prevention and treatment guidelines for pregnant people. The Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States were last updated a year ago. The new guidelines are available for free at HIV.gov.

The new guidelines keep dolutegravir (sold alone as Tivicay and included in the Triumeq, Dovato and Juluca single-tablet regimens) as a preferred medication for people living with HIV who become pregnant. Dolutegravir was previously linked to neural tube birth defects, but further study showed that the risk was not significantly higher compared with regimens that don’t contain the drug.

The updated recommendations add tenofovir alafenamide (TAF)—a component of several HIV combinations, including Descovy, Biktarvy, Genvoya, Odefsey and Symtuza—as a preferred nucleoside reverse transcriptase inhibitor for pregnant people. However, they also included data about weight gain associated with TAF use.

What’s more, when people taking Biktarvy become pregnant, they may need more frequent viral load monitoring. Because there are insufficient data about use of another Biktarvy component, bictegravir, during pregnancy, the guidelines panel recommended that pregnant people using the drug should receive viral load tests every one to two months. The same goes for pregnant people using doravirine (Pifeltro or Delstrigo).

The guidelines say that people who become pregnant while taking modern two-drug regimens, such as Dovato (dolutegravir/lamivudine) or Juluca (dolutegravir/rilpivirine), can stay on those medications into pregnancy, as long as they have had an undetectable viral load for a while. Here, too, they call for viral load testing every one to two months.

The guidelines caution providers to carefully monitor infants born to people using the HIV attachment inhibitor Trogarzo (ibalizumab) because of a monkey study that found “reversible immunosuppression” in infants.

The panel also recommended against using the new long-acting injectable regimen Cabenuva (long-acting injectable cabotegravir/rilpivirine)—not because there’s evidence of harm but because there’s no evidence at all for pregnant people and their infants. They advise that people who have an undetectable viral load on Cabenuva should still switch to another option during pregnancy.

Other updates:

• In keeping with last year’s recommendations, the guidelines expand the use of gender-neutral terms to discuss pregnant people, adding an explanation to the introduction.
• The guidelines have a new section specifically addressing HIV care during pregnancy for transgender and gender-diverse people assigned female at birth and guidance for clinicians on how to counsel gender-diverse and transgender people living with HIV about reproductive options.
• The updated guidelines add a recommendation that clinicians should discuss HIV pre-exposure prophylaxis (PrEP) with pregnant people, in particular people experiencing domestic violence and those who have used multiple courses of post-exposure prophylaxis (PEP).

Click here to read the full recommendations.

By Heather Boerner