Remdesivir | TERIS agent - 6800

TERIS Summary
TERIS Agent Number: 6800 Bibliographic Search Date: 05/2020
Agent Name: REMDESIVIR    

 

Remdesivir is a nucleotide analog with broad-spectrum antiviral activity that is administered intravenously in the treatment of SARS-CoV-2 (which causes COVID-19) and other serious viral infections.


Magnitude of Teratogenic Risk to Child Born After Exposure During Gestation:
 
UNDETERMINED

Quality and Quantity of Data on Which Risk Estimate is Based:
 
VERY LIMITED

Comments:   

MITOCHONDRIAL DNA DEPLETION AND MITOCHONDRIAL DYSFUNCTION HAVE BEEN REPORTED AMONG CHILDREN WHOSE MOTHERS WERE TREATED DURING PREGNANCY WITH NUCLEOSIDE ANALOG REVERSE TRANSCRIPTASE INHIBITORS (PLEASE SEE AGENT SUMMARY ON ZIDOVUDINE FOR MORE INFORMATION). IT IS NOT KNOWN IF THIS CAN OCCUR WITH REMDESIVIR.

Summary of Teratology Studies:

No stillbirths or neonatal deaths were reported among 33 infants born to 64 women with severe or critical COVID-19 disease during the second or third trimester of pregnancy in one series (Pierce-Williams et al., 2020). Seventeen of the 64 women were treated with remdesivir.

 

Six pregnant women were given remdesivir in a randomized, controlled trial of four different medications designed to treat Ebola virus disease (Mulangu et al., 2019). No serious adverse neonatal events attributable to remdesivir were reported in this study.

 

Animal teratology studies of remdesivir conducted by the manufacturer have not been published in the peer-reviewed literature.

 

 

Selected References:
(Each paper is classified as a review [R], human case report [C], human epidemiological study [E], human clinical series [S], animal study [A], or other [O].)

Mulangu S, Dodd LE, Davey RT Jr, Tshiani Mbaya O, Proschan M, Mukadi D, Lusakibanza Manzo M, Nzolo D, Tshomba Oloma A, Ibanda A, Ali R, Coulibaly S, Levine AC, Grais R, Diaz J, Lane HC, Muyembe-Tamfum J-J; PALM Writing Group: A randomized, controlled trial of ebola virus disease therapeutics. N Engl J Med 381(24):2293-2303, 2019. [E]

 

Pierce-Williams RAM, Burd J, Felder L, Khoury R, Bernstein PS, Avila K, Penfield CA, Roman AS, DeBolt CA, Stone JL, Bianco A, Kern-Goldberger AR, Hirshberg A, Srinivas SK, Jayakumaran JS, Brandt JS, Anastasio H, Birsner M, O'Brien DS, Sedev HM, Dolin CD, Schnettler WT, Suhag A, Ahluwalia S, Navathe RS, Khalifeh A, Anderson K, Berghella V: Clinical course of severe and critical COVID-19 in hospitalized pregnancies: a US cohort study. Am J Obstet Gynecol MFM 2020 May 8 (published ahead of print). [S]

COVID-19 PREGNANCY STUDIES

 

Pregnancy studies have been established for women infected with, or exposed to, the SARS-CoV-2 coronavirus (which causes COVID-19) during pregnancy.

Healthcare providers are encouraged to enroll such patients, whether or not they have been treated with remdesivir, in the MotherToBaby Pregnancy Study by calling 877-311-8972 (https://mothertobaby.org/join-study/) or in the PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) Study by calling 415-754-3729 (https://priority.ucsf.edu/).