From the Guidelines
Remdesivir should be used in pregnant women with COVID-19 only when the potential benefits outweigh the possible risks to the mother and fetus, as current evidence from compassionate use programs and pregnancy registries has not identified significant safety concerns or adverse pregnancy outcomes specifically attributed to remdesivir 1.
Key Considerations
- The standard adult dosing regimen for COVID-19 is 200 mg IV on day 1, followed by 100 mg IV daily for a total treatment duration of 5-10 days, depending on disease severity, and pregnant women with COVID-19 requiring antiviral therapy should receive the same dosing as non-pregnant adults 1.
- Remdesivir works by inhibiting viral RNA-dependent RNA polymerase, preventing viral replication, and animal studies have not shown evidence of harm to the developing fetus at clinically relevant doses 1.
- However, pregnancy-specific pharmacokinetic data is lacking, and the drug should be used as part of a comprehensive treatment approach for COVID-19 in consultation with infectious disease specialists and maternal-fetal medicine experts who can help weigh individual risk-benefit considerations 1.
Safety and Efficacy
- The FDA recommends that clinicians assess kidney and hepatic function at baseline and during treatment, and not use remdesivir in patients with an estimated glomerular filtration rate <30 mL/min/1.73 m2 or discontinue its use if alanine aminotransferase levels increase to >10 times the upper limit of normal or if alanine aminotransferase elevation is accompanied by signs or symptoms of liver inflammation 1.
- Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and after administration of remdesivir, and additional adverse events include metabolic, hepatic, and renal events 1.
Clinical Judgment
- The decision to initiate treatment with remdesivir in hospitalized patients with COVID-19 should be based on clinical judgment, and remdesivir should not necessarily be initiated in patients hospitalized for a primary diagnosis unrelated to COVID-19 who have incidentally tested positive for severe acute respiratory syndrome coronavirus 2 1.
- For hospitalized patients with COVID-19 whose condition worsens within a 5-d course to require supplemental oxygen but not mechanical ventilation, extending the use of remdesivir should be based on clinical judgment and the balance of benefits and harms 1.
From the FDA Drug Label
Available data from a clinical trial (IMPAACT 2032), published reports, the COVID-PR pregnancy exposure registry, and compassionate use of remdesivir in pregnant individuals have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes following exposure in the second and third trimester However, there are insufficient pregnancy data available to evaluate the risk of remdesivir exposure during the first trimester. In nonclinical reproductive toxicity studies, remdesivir demonstrated no adverse effect on embryo-fetal development when administered to pregnant animals at systemic exposures (AUC) of the predominant circulating metabolite of remdesivir (GS-441524) that were 4 times (rats and rabbits) the exposure in humans at the recommended human dose (RHD)
The safety of remdesivir in pregnancy is not fully established, particularly in the first trimester, due to insufficient data. However, available data from the second and third trimester do not indicate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes 2.
- Key points:
- No increased risk of major birth defects or adverse outcomes in the second and third trimester
- Insufficient data for the first trimester
- No dose adjustments recommended for pregnant patients It is essential to weigh the potential benefits and risks of remdesivir treatment in pregnant individuals, considering the maternal and fetal risks associated with untreated COVID-19.
From the Research
Safety of Remdesivir in Pregnancy
- The use of remdesivir in pregnant women with severe COVID-19 has been studied in several research papers 3, 4, 5, 6, 7.
- A study published in 2021 found that remdesivir was well tolerated in pregnant women with severe COVID-19, with a low incidence of serious adverse events (16%) 3.
- Another study published in 2022 found that remdesivir improved the clinical condition of pregnant patients with COVID-19, especially those who had a better clinical status at baseline and received earlier remdesivir treatment 4.
- A systematic review of antiviral therapy for COVID-19 in pregnancy found that remdesivir was associated with improved clinical outcomes, including lower rates of ICU admission, decreased length of hospitalization, and decreased progression to critical disease 5.
- A review of remdesivir for COVID-19 in pregnancy and lactation found that despite the lack of data from clinical trials, accumulating evidence from post-marketing registries, compassionate use programs, and case series/reports suggests that remdesivir may be safe and effective in pregnancy 6.
- A secondary analysis of the COVID in Pregnancy Registry found that remdesivir appears to be safe and well tolerated in pregnant women with moderate, severe, or critical COVID-19, with no cases of recorded adverse reaction 7.
Adverse Events
- The most commonly reported adverse event associated with remdesivir use in pregnancy was transaminitis, which was more common in patients who received a 10-day course of treatment compared to a 5-day course 4.
- Another study found that 16.7% of patients had the medication discontinued due to transaminitis 7.
- Other adverse events reported in the studies included pregnancy-related hypertension, chorioamnionitis, stroke, delivery with estimated blood loss >1000 mL, diagnosis of pulmonary embolism or deep venous thromboembolism, or maternal death 7.