When the antiviral medication Paxlovid first became available in late 2021, it changed the way doctors thought about treating COVID-19. But for pregnant people who have COVID-19, the choice of whether you feel taking Paxlovid can still be a tough one.
Even though pregnant patients are considered high risk for severe COVID-19, there wasn't a ton of research on the potential safety risks and benefits of taking Paxlovid when pregnant until fairly recently.
That's why so many "providers didn't want to give Paxlovid (to pregnant patients) or were worried about it as a new drug, and a lot of patients were leery about taking it," Dr. Kelly Gebo, epidemiologist and professor of medicine at Johns Hopkins University, tells TODAY.com.
But new evidence suggests that the Paxlovid is safe enough that pregnant people should seriously consider taking it if they develop COVID-19.
"I strongly believe that Paxlovid is an important part of how we minimize risk in the setting of COVID infection for moms and babies," Dr. Neil Silverman, professor of clinical obstetrics and gynecology at the UCLA David Geffen School of Medicine, tells TODAY.com.
When should you consider taking antivirals like Paxlovid?
Antiviral medications can help people diagnosed with COVID-19 and have underlying risk factors that make it more likely that they'll develop severe symptoms.
"As we enter the third year of the pandemic now, we've been able to use antiviral medications for people who are at higher risk of developing more severe outcomes if they wind up getting COVID-19, even if they've been vaccinated — and especially if they have not," says Silverman, who is also the director of UCLA’s infectious diseases in pregnancy program.
Those risk factors can include certain chronic medical conditions, a history of smoking, mental health conditions and pregnancy, according to the Centers for Disease Control and Prevention.
There are two antivirals that high-risk patients can take at home: molnupiravir (Lagevrio), and nirmatrelvir with ritonavir (Paxlovid). Another antiviral medication, remdesivir (Veklury), is only available at health care facilities because it's administered intravenously.
These medications are particularly useful in keeping high-risk patients who’ve been diagnosed with COVID-19 out of the hospital, TODAY.com explained previously.
Pregnant people face unique risks from COVID-19
Being pregnant creates a higher risk for severe COVID-19 symptoms and hospitalization. A COVID-19 infection in pregnancy also poses unique risks to the developing fetus, such as preterm birth, pregnancy loss and stillbirth.
"It's not that the virus gets directly to the fetus," Silverman explains, "but if the mother becomes severely ill, all of the inflammation that is brewing in her system also sets up a risk for preterm labor."
Antivirals like Paxlovid can be helpful "not just for maternal illness, which is obviously important, but also to prevent severe maternal illness from potentially impacting the outcome of the pregnancy," Silverman says.
And that's especially true for pregnant people who aren't vaccinated, he says.
In fact, because pregnancy is considered a risk factor for severe COVID-19, “this makes pregnant patients, including those with pregnancy as their only risk factor, eligible to receive (Paxlovid),” according to the most recent guidance from the American College of Obstetricians and Gynecologists.
Is it safe to take Paxlovid when you're pregnant?
The hesitance around prescribing Paxlovid during pregnancy is often due to a lack of information.
"There is no experience treating pregnant women or breastfeeding mothers with Paxlovid," according to an FDA fact sheet from February 2023. "For a mother and unborn baby, the benefit of taking Paxlovid may be greater than the risk from the treatment."
While pregnant people were not included in the original clinical trials for Paxlovid — which is a common practice, Gebo says — emerging evidence from new research suggests that Paxlovid is generally safe to take during pregnancy, so the potential benefits may outweigh the possible risks in many cases.
For instance, a study published in November 2022 in JAMA Network Open tracked 47 pregnant patients who took Paxlovid for COVID-19. The researchers didn't find any signs that the medication caused an increase in birth defects or delivery complications.
"The reassuring thing is that the patients who took it didn't seem to have any worse fetal outcomes than the general pregnant population," says Gebo, who is also an author on the study.
These preliminary results suggest Paxlovid "might be a drug that is safe for moms and fetuses, particularly high-risk moms who might be at risk of adverse outcomes from a COVID infection," she adds.
On the other hand, the antiviral Lagevrio, which is different from Paxlovid, is specifically not recommended during pregnancy, according to safety information from manufacturer Merck.
“Based on findings from animal reproduction studies, Lagevrio may cause fetal harm when administered to pregnant individuals,” the fact sheet says. “There are no available human data on the use of Lagevrio in pregnant individuals to evaluate the risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.”
With the available evidence, the COVID-19 treatment panel at the National Institutes of Health “recommends against the use of molnupiravir for the treatment of COVID-19 in pregnant patients unless there are no other options and therapy is clearly indicated.”
What we know from previous research
Paxlovid is a type of antiviral called a protease inhibitor, Silverman explains. And it actually contains two drugs: nirmatrelvir (a new protease inhibitor) and ritonavir, another protease inhibitor that helps to boost the effects of nirmatrelvir, Gebo says.
"Obviously, the data are relatively limited because Paxlovid has only been available for the past year," Silverman says. "But we can draw corollaries to our experience using protease inhibitors since the '90s in pregnant people with no long-term outcome issues in those children."
In particular, doctors have been using ritonavir to help HIV patients — including pregnant people — manage the disease for decades now, Silverman says.
And when it comes to nirmatrelvir, experts haven't seen any worrying signs yet. Rather than affecting a part of your immune system, Paxlovid works directly on the virus to keep it from replicating, Gebo explains. “So there is less concern about an adverse consequence to the mom or developing fetus,” she adds.
There's nothing about "this COVID-specific protease inhibitor that would lead any of us to think that it would present a different safety profile than other protease inhibitors that have been used," Silverman agrees.
Bottom line: Talk to your doctor.
Ultimately, pregnancy should not be a reason to avoid Paxlovid, the experts agreed. And if you develop COVID-19 while pregnant, it's worth talking to your doctor about your options, which might include antiviral medications.
Providers should consider prescribing Paxlovid to pregnant patients especially when the patient has another condition that puts them at a higher risk for severe COVID-19, ACOG says.
But ACOG also notes a lack of conclusive data, advising "clinicians (to) weigh the available data against the individual risks of COVID-19 in pregnancy in each situation," the organization says.
It's also important to remember that Paxlovid can interfere with other medications, including some commonly prescribed psychiatric drugs and hormonal birth control options, as TODAY.com explained previously. And people with certain other health conditions, like liver disease, should be extremely cautious when taking Paxlovid, the NIH panel explains.
The key is to talk it over with your doctor, who can give you personalized guidance based on your specific circumstances. Because these medications work better the earlier you take them, it. makes sense to have the discussion when you don't have COVID-19 so you can get it quickly in the event that you test positive.
"It may be that you have an educated conversation with your provider and choose not to take it, which is a perfectly reasonable thing to do," Gebo says. "But I think each and every pregnant patient should discuss it with their provider to make an informed decision that is best for them."
Silverman agrees: "Those of us who work with pregnant people are going to have the best interests of the mom and the baby at heart. We are using the best evidence we have to protect both of them."
