Monica Gandhi, MD, MPH: The Unknowns of ART in Pregnancy

In a symposium presented at the Annual Conference on Retroviruses and Opportunistic Infections (CROI 2019), Monica Gandhi, MD, MPH, professor of medicine and associate division chief at the University of California San Francisco's Division of HIV, Infectious Diseases, and Global Medicine, discussed the safety of antiretroviral therapy in pregnancy and in women of reproductive potential, as well as the hurdles that exist in receiving comprehensive safety data.

Contagion® sat down with Dr. Gandhi for an exclusive interview to break down her symposium talk on treating HIV in pregnancy.

Interview transcript (modified slightly for readability):Contagion®: What sorts of decisions do women of reproductive potential face when weighing ART options?

Dr. Gandhi: Women face a lot of unknowns unfortunately when weighing what options to use during pregnancy because we don't have great data on the use of antiretrovirals during pregnancy. This session at CROI where we discuss this really talked about how women have been traditionally excluded if they're of reproductive age or pregnant from trials and how we need to completely flip that around and justify our exclusion and and not justify inclusion. But at this moment if you look at all the antiretrovirals that are available to treat HIV in 2019, which is an amazingly wide swath of medications and it's exciting to treat HIV in 2019 with all these options, you have to take away so many of those that are at least not recommended or we don't know enough about them during pregnancy.

Contagion®: What about the safety of pre-exposure prophylaxis (PrEP) in women of reproductive potential?

Dr. Gandhi: In terms of the safety of PrEP in women of reproductive potential, PrEP is safe. There are some theoretical concerns that [in] women who are pregnant taking TDF and FTC, [that] there can be a little bit of bone effect on the fetus. Not a big deal, not something that in a risk-benefit analysis overwhelms the amazing benefit of being protected for the risk of HIV during pregnancy. If one gets HIV during pregnancy, there're such high viral loads and there's a very high rate of transmission to the baby so not good for the mother, not good for the fetus. If you're at risk, take PrEP. That is the right thing [for] we as providers to advise women who are at risk during pregnancy.

Contagion®: How do we shorten the delay that exists between FDA approvals and pregnancy safety data?

Dr. Gandhi: Right now there's big gap between FDA approvals for medications and then having data in women to inform providers so they're not flying blind and figuring out what to use in women. The way to shorten that gap is for drug companies to actually follow FDA guideline. The guidelines—and they're not mandates, they're guidelines and there's really debate about that—say enroll adequate numbers of women in your study to look at a drug's difference to perform sex-delineated outcomes. If we enrolled enough women to begin with, then we would have data on men and women by the time that FDA approval is even filed for a drug. That is the recommendation by the FDA; it is, however, not a mandate. And because it's not a mandate and drug companies are in a hurry, they often do not take the time and the care to enroll adequate numbers of women, and that is true, by the way, for racial and ethnic minorities as well. What would be important is the question of, "can we make this a stronger recommendation?" To say, "enroll adequate numbers of women." Can we say that if you're pregnant, you should be allowed to be in the trial unless there's a very good reason not to? And so all of this is being looked at now and I do have to say that I think changes are coming.