Management of cytomegalovirus infection in pregnancy: is it time for valacyclovir?


Journal

Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
ISSN: 1469-0691
Titre abrégé: Clin Microbiol Infect
Pays: England
ID NLM: 9516420

Informations de publication

Date de publication:
Sep 2020
Historique:
received: 07 02 2020
revised: 26 03 2020
accepted: 05 04 2020
pubmed: 15 4 2020
medline: 3 7 2021
entrez: 15 4 2020
Statut: ppublish

Résumé

Congenital cytomegalovirus (CMV) infection is the leading infectious cause of neurological impairment for which, currently, there are no approved antenatal treatment options. The aim of this article was to summarize the available evidence on the use of valacyclovir during pregnancy to prevent and treat congenital CMV infection and disease. Two databases (PubMed and ClinicalTrial.gov) were reviewed. Six relevant documents were identified, namely one observational study, three clinical trials, two case reports. Most relevant findings were those from two clinical trials. A phase 2/3 placebo-controlled study showed a decrease of 71% (5 of 45 vs 14 of 47) in rate of CMV vertical transmission in women treated with 8 g/day valacyclovir following primary CMV infection in pregnancy. A phase 2, single-arm clinical trial, showed that 8 g/day valacyclovir administered to mothers of symptomatic infected foetuses increased the portion of asymptomatic neonates to 82% (34 of 41), compared with 43% (20 of 47) in untreated pregnancies from a historical cohort. Studies in favour of using valacyclovir during pregnancy for prevention and treatment of congenital CMV infection are emerging but are still few. Randomized clinical trials on large cohorts of patients investigating the efficacy on prevention and treatment of congenital CMV are required. Unfortunately, this will be probably not be feasible at least in the short period. In the meantime, data on the 'off label' use of valacyclovir for CMV in pregnancy could be collected within a multicentre observational study.

Sections du résumé

BACKGROUND BACKGROUND
Congenital cytomegalovirus (CMV) infection is the leading infectious cause of neurological impairment for which, currently, there are no approved antenatal treatment options.
OBJECTIVES OBJECTIVE
The aim of this article was to summarize the available evidence on the use of valacyclovir during pregnancy to prevent and treat congenital CMV infection and disease.
SOURCES METHODS
Two databases (PubMed and ClinicalTrial.gov) were reviewed.
CONTENT BACKGROUND
Six relevant documents were identified, namely one observational study, three clinical trials, two case reports. Most relevant findings were those from two clinical trials. A phase 2/3 placebo-controlled study showed a decrease of 71% (5 of 45 vs 14 of 47) in rate of CMV vertical transmission in women treated with 8 g/day valacyclovir following primary CMV infection in pregnancy. A phase 2, single-arm clinical trial, showed that 8 g/day valacyclovir administered to mothers of symptomatic infected foetuses increased the portion of asymptomatic neonates to 82% (34 of 41), compared with 43% (20 of 47) in untreated pregnancies from a historical cohort.
IMPLICATIONS CONCLUSIONS
Studies in favour of using valacyclovir during pregnancy for prevention and treatment of congenital CMV infection are emerging but are still few. Randomized clinical trials on large cohorts of patients investigating the efficacy on prevention and treatment of congenital CMV are required. Unfortunately, this will be probably not be feasible at least in the short period. In the meantime, data on the 'off label' use of valacyclovir for CMV in pregnancy could be collected within a multicentre observational study.

Identifiants

pubmed: 32289479
pii: S1198-743X(20)30193-2
doi: 10.1016/j.cmi.2020.04.006
pii:
doi:

Substances chimiques

Antiviral Agents 0
Valacyclovir MZ1IW7Q79D

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

1151-1154

Informations de copyright

Copyright © 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Auteurs

L Zammarchi (L)

Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Infectious and Tropical Diseases Unit, Careggi University and Hospital, Florence, Italy; Referral Center for Infectious Diseases in Pregnancy of Tuscany, Florence, Italy. Electronic address: lorenzo.zammarchi@unifi.it.

T Lazzarotto (T)

Virology Laboratory, Department of Specialized, Experimental, and Diagnostic Medicine, Polyclinic St. Orsola, University of Bologna, Bologna, Italy.

M Andreoni (M)

Clinical Infectious Diseases, Tor Vergata University, Rome, Italy.

I Campolmi (I)

Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.

L Pasquini (L)

Fetal Medicine Unit, Department for Women and Children Health, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.

M Di Tommaso (M)

Department of Health Sciences, Obstetrics and Gynecology Branch, University of Florence, Florence, Italy.

G Simonazzi (G)

Division of Obstetrics and Prenatal Medicine, Department of Medical Surgical Sciences, Polyclinic St. Orsola, Bologna, Italy.

L R Tomasoni (LR)

University Department of Infectious and Tropical Diseases, University of Brescia and Spedali Civili General Hospital, Brescia, Italy.

F Castelli (F)

University Department of Infectious and Tropical Diseases, University of Brescia and Spedali Civili General Hospital, Brescia, Italy; UNESCO Chair "Training and Empowering Human Resources for Health Development in Resource-limited Countries, University of Brescia", Italy.

L Galli (L)

Department of Health Sciences, University of Florence, Paediatric Infectious Diseases Division, Anna Meyer Children's University Hospital, Florence, Italy.

B Borchi (B)

Infectious and Tropical Diseases Unit, Careggi University and Hospital, Florence, Italy; Referral Center for Infectious Diseases in Pregnancy of Tuscany, Florence, Italy.

P Clerici (P)

Microbiology Unit, ASST-Ovest Milanese, Legnano Hospital, Legnano, Italy.

A Bartoloni (A)

Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Infectious and Tropical Diseases Unit, Careggi University and Hospital, Florence, Italy.

M Tavio (M)

Unit of Emerging and Immunosuppressed Infectious Diseases, Department of Gastroenterology and Transplantation, Polytechnic University of Marche, Ancona, Italy.

M Trotta (M)

Infectious and Tropical Diseases Unit, Careggi University and Hospital, Florence, Italy; Referral Center for Infectious Diseases in Pregnancy of Tuscany, Florence, Italy.

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