In a recent study published in Obstetrics & Gynecology, researchers investigated the short-term outcomes of treating pregnant patients exhibiting mild to moderate symptoms of coronavirus disease 2019 (COVID-19) with Paxlovid, which is a combination of the antivirals nirmatrelvir and ritonavir.
Study: Short-term Pregnancy Outcomes After Nirmatrelvir–Ritonavir Treatment for Mild-to-Moderate Coronavirus Disease 2019 (COVID-19). Image Credit: Nutlegal Photographer/Shutterstock
Background
One of the antiviral therapies approved by the United States Food and Drug Administration for emergency use during the COVID-19 pandemic is Paxlovid. It is a combination therapy consisting of antivirals nirmatrelvir and ritonavir. When administered within five days of onset of symptoms, the therapy has been seen to reduce the hospitalization and mortality risk during severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections.
The treatment has also shown promising results against the SARS-CoV-2 Omicron variant. However, no clinical trials have evaluated the efficacy of the treatment in pregnant COVID-19 patients.
About the study
In the present descriptive study, pregnant patients diagnosed with COVID-19 confirmed through positive polymerase chain reaction (PCR) tests of nasopharyngeal swabs were considered eligible for nirmatrelvir-ritonavir treatment if they exhibited mild to moderate symptoms in the previous five days and did not require oxygen or hospitalization.
Pregnant patients who were unvaccinated were also eligible for the therapy. A follow-up was conducted eight to 10 days following the onset of symptoms to assess the resolution of disease symptoms, completion of treatment, and adverse reactions to the treatment.
Results
The results reported that all 11 patients who were eligible for the nirmatrelvir-ritonavir treatment agreed to the treatment, but four of the pregnant patients did not initiate treatment. The treatment regimen consisted of 300 mg of nirmatrelvir and 100 mg of ritonavir administered orally twice daily for five days.
The treatment was initiated approximately two days from the onset of symptoms after teleconsultation with a maternal-fetal medicine specialist. The average gestation age of the participants was 26 3/7 weeks, and six of the patients had completed the primary vaccinations, while four had also received booster doses.
Apart from one patient who developed dysgeusia and discontinued treatment after two days, none of the patients reported any adverse reactions. All COVID-19 symptoms were resolved in the remaining seven patients without additional medical requirements.
Out of the seven pregnant patients that completed the nirmatrelvir-ritonavir treatment regimen, labor was induced in one at 37 2/7 weeks due to cholestasis of pregnancy. Another patient was diagnosed with hypertension after delivery at 40 3/7 weeks, but the neonate was healthy. A third patient opted for induced labor at 39 1/7 weeks and delivered a healthy baby. The remaining four patients were still pregnant when the study was completed, with no complications from the COVID-19 treatment. The perinates were also healthy and showed no adverse effects of the nirmatrelvir-ritonavir treatment.
Conclusions
To summarize, the study investigated the short-term outcomes of nirmatrelvir-ritonavir treatment in pregnant patients diagnosed with mild to moderate COVID-19, not requiring oxygen or hospitalization.
All patients who received the nirmatrelvir-ritonavir treatment reported a complete resolution of all COVID-19 symptoms after completing the treatment. One patient developed dysgeusia, but none of the others developed any adverse reactions. Furthermore, there were no complications during the pregnancy or birth, and no adverse effects were observed for the fetus or neonates.
The authors believe that despite the promising results of this study, more clinical trials need to be conducted to determine the safety and efficacy of oral COVID-19 antivirals in pregnant patients, including studies on long-term outcomes and adverse reactions in neonates.
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