Paxlovid Safety During Pregnancy
Paxlovid (nirmatrelvir/ritonavir) can be considered for use during pregnancy on a case-by-case basis after thorough discussion with the patient about potential risks and benefits, with a multidisciplinary approach involving hepatology and obstetric services. 1
Evidence for Safety in Pregnancy
- Limited clinical data exists regarding the safety and efficacy of Paxlovid in pregnant women, as pregnant women were excluded from initial clinical trials 2
- Animal studies of nirmatrelvir showed no evidence of teratogenicity or adverse effects on fertility and early embryonic development, even at high doses up to 1000 mg/kg/day 3
- Indirect evidence from ritonavir (one component of Paxlovid) used in HIV treatment during pregnancy has shown no significant teratogenic effects 2
- A small study of 30 pregnant women treated with Paxlovid during the Omicron wave showed effectiveness in reducing symptom duration without severe adverse events, though there was a higher rate of cesarean delivery observed 4
Clinical Experience and Adverse Effects
- In a cross-sectional study of vaccinated pregnant individuals who took nirmatrelvir-ritonavir:
- 91.7% experienced dysgeusia (taste disturbance)
- 50% experienced COVID rebound (either positive test results or return of symptoms)
- No significant adverse pregnancy outcomes were reported 5
- The most common reason for declining Paxlovid during pregnancy was concern about unknown risks 5
Current Recommendations
- Treatment during pregnancy should be considered only on a case-by-case basis after thorough discussion with the patient about potential risks and benefits 1
- Decision-making should involve a collaborative approach between hepatology and obstetric services 1
- For pregnant women with COVID-19 requiring treatment, dexamethasone is currently the only proven and recommended experimental treatment for those who are mechanically ventilated or require supplemental oxygen 6
Breastfeeding Considerations
- There is insufficient data regarding Paxlovid use during lactation 2
- For other antiviral medications like tenofovir, studies have shown low levels in breast milk and substantially lower drug exposures than in utero, suggesting breastfeeding may be compatible with some antiviral treatments 1
Clinical Decision-Making Algorithm
- Assess COVID-19 severity and risk factors for progression to severe disease
- Consider gestational age and underlying maternal conditions
- Discuss potential risks and benefits with the patient
- Involve a multidisciplinary team including obstetrics and infectious disease specialists
- If treatment is initiated, monitor closely for adverse effects and pregnancy outcomes
Conclusion
While limited data exists on Paxlovid use during pregnancy, the available evidence suggests it may be considered in certain situations where the potential benefits outweigh the unknown risks. Animal studies are reassuring, and small human studies have not shown severe adverse effects, but more research is needed to establish definitive safety guidelines.