Dr William R. Short Speaks About Changes in Treatment of Pregnant People With HIV After Label Update

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 in a way that is both safe for them and their fetus as well as an effective means of treatment for the disease. This could affect the way that people living with HIV who may become pregnant are treated for the disease.

Transcript

What can be done differently in future clinical trials to treat pregnant people with HIV more effectively?

Sure. So, we know that pregnancy is often an exclusion criteria, when we're looking at new clinical trials or studies. And what happens then is that we have no data. And we have no data on efficacy [and] safety. And so therefore, what that leaves is a person and a clinician to make decisions with very limited evidence.

So, what we need to do, and there's been a big push, is we need to actually start allowing people who are pregnant to be included in clinical trials. There was a recent [book] just released this month, called "Advancing Clinical Research With Pregnant and Lactating Populations." And what I think is really important about that [book]—and I encourage everyone to download it and read it, it's free—is that what it does is it really calls on key players such as the FDA, Congress, and National Institutes of Health to really, really, really work to make sure that we include pregnant people and lactating people in clinical studies. So we don't have to wait 6 or 8 years until that data becomes available.

Because what happens is, when a drug is approved—and a perfect example is Biktarvy, which is the bictegravir or the integrase [strand-transfer inhibitor]—that drug comes to market [and] we have very limited pregnancy data. But guess what? It's used widely in non-pregnant populations. And so, you prescribe it, and you go along, and people don't think, "Well, a pregnancy could happen." A person gets pregnant and then we're playing catch up because most people don't get pregnant and come in in a week and say, "Oh, I'm pregnant," [and] we stop the drug. Most people come in long after really all the organs are formed. So having this data is really, really, really key, and I'm glad we have it. Looking ahead, I think what we need to do is have these studies at the time that drug is FDA approved, then we don't have to worry about [it taking] 4, 6, 8 years until we have this data.

What should doctors keep in mind when treating people with HIV who may become pregnant?

I think my comment that I'll leave most people with is to really think about when you have someone in front of you who is not pregnant, that if there is a possibility, they could become pregnant at some point to really think about the drug that they're on—the antiretroviral—think about that drug. And then also counsel. Counsel what's available. That information is in the label. People are used to pregnancy categories. We no longer use them, we use like pregnancy lactation rule.

So if you pull out the package insert, really what is known about pregnancy, and lactation is all included in that label. So again, it's important to counsel people and patients on that when you have them in front of you, and just think that a pregnancy can occur. And it's important to remember that. But again, I applaud [Gilead] for making that label change. I think it's really important that we have that now.

References

1. FDA approves Biktarvy label update with data for pregnant adults with HIV. News Release. Gilead. April 26, 2024. Accessed May 2, 2024. https://www.gilead.com/news-and-press/press-room/press-releases/2024/4/fda-approves-biktarvy-label-update-with-data-for-pregnant-adults-with-hiv
2. Foster Riley M, Helman A, March A. Advancing Clinical Research with Pregnant and Lactating Populations. The National Academies Press;2024. Accessed May 2, 2024. https://nap.nationalacademies.org/catalog/27595/advancing-clinical-research-with-pregnant-and-lactating-populations-overcoming-real