Dr William Short Discusses Bictegravir Label Update, Effect on Pregnant People With HIV

William R. Short, MD, MPH, of the University of Pennsylvania, discusses how a label update for bictegravir can help provide safe and effective HIV treatment for pregnant people.

William R. Short, MD, MPH, an associate professor of clinical medicine at the University of Pennsylvania who provides care for adults with infectious diseases, spoke about the label update for bictegravir (Biktarvy) that was approved on April 26. The medication, which is used primarily to treat people living with HIV, can now be used by pregnant people living with HIV with confidence that it is both safe for them and their fetus as well as an effective means of treatment for the disease.


How important is the label update of bictegravir for pregnant people living with HIV?

Excellent question. So I think this update is extremely important, and actually timely now for pregnant people living with HIV, largely because the drug was approved by the FDA in 2018 and here we are in 2024. And we know from looking at other drugs and products that it takes, on average, about 6 years to get pharmacokinetic data from the time of FDA approval to now. And when we look at safety data, there's a median of about 4 years. So the fact that we actually have that now is extremely important and it can help people live with HIV and their providers feel comfortable that what they're taking is actually safe and effective during pregnancy.

What should patients be aware of when using bictegravir?

So right now, prior to this label update, or prior to this last year, we really didn't have data showing us a couple things. So 1, pharmacokinetic data, which is the level of the drugs. Typically, when drugs get approved, we have pharmacokinetic data, but we know that when someone's pregnant there are actually changes in your body that are normal—they're physiologic and associated with the pregnancy—but those changes can actually bring about a decline in the level of the drugs. And we know what happens when you have declines in the level of those drugs. It may not work, you may have detectable viremia and can lead to transmission. So we want to make sure they're adequate, so that's one thing we need to study. The other thing we need to study and look at is safety. And it's not only safety for the person who's pregnant, but it's also safety for the fetus, and then the newborn. And so finally, now we have that, after all these years. We do have studies to show all of that, which is really what prompted this label change to allow people and providers to know that what we have now is safe and effective and can be used as an alternative in pregnancy.

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