HIV Guidelines: Quick Hitters From the Recent HHS Update

With the entire world embroiled in combat against the COVID-19 pandemic, it is easy to forget that HIV remains a global epidemic according to the World Health Organization. As the number of HIV treatment options have burgeoned and patient management has democratized well beyond HIV specialists into fields such as primary and family care, clinicians are compelled to remain abreast of key practice updates.

The US Health and Human Services (HHS) treatment guidelines are revised regularly by a rotating panel of practicing HIV clinicians, researchers, and expert consultants. They represent the "gold standard" of our accumulated knowledge regarding the optimal approaches to antiretroviral therapy within the US.

Among the most notable changes are a treatment for use in pregnant women as well as an increase in use of two-drug regimens.

The June 3, 2021, update to the guidelines marks their first revision in a year and a half.

Dolutegravir (Tivicay) Cleared for Use in Pregnancy

The latest update essentially clarifies that dolutegravir is safe for use in women of childbearing age who may become pregnant. Prior data from 2018 study, suggested a link between dolutegravir exposure in the birth parent and neutral tube defects in infants. Subsequent research ultimately found that those early findings significantly overestimated the overall risk of neural tube defects. Accordingly, the updated HHS treatment guidelines now clear the use of dolutegravir “for most people with HIV who are of childbearing potential.”

While this new recommendation is reassuring, patients still require counseling on the risks and benefits of using this drug during pregnancy.

In a corresponding move, raltegravir—which was the drug of choice over dolutegravir in patients of childbearing age—gets a downgrade. Raltegravir has a lower barrier to resistance than dolutegravir and bictegravir. Raltegravir-based regimens also have a higher pill burden than other integrase strand transfer inhibitor (INSTI)–based regimens and are not available as part of a single-tablet regimen. 

Two-drug Regimens Continue to Gain Momentum

Two drug regimens with a high barrier to resistance—such as those containing boosted darunavir or dolutegravir—continue to accrue favorable data. Dolutegravir/lamivudine is FDA approved for initial therapy for treatment‐naïve individuals provided their viral load is less than 500,000 copies/mL and there is no demonstrated resistance to either drug. Dolutegravir/rilpivirine, on the other hand, is only recommend as a switch therapy for patients with sustained viral suppression for over 6 months and no evidence of resistance to either agent.

As data continues to mount affirming the potency of these regimens, so too does the HHS guidelines’ confidence in recommending them—such that the latest update more fully embraces their use as a switch regimen in people who are experiencing virologic failure.

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