The ribavirin pregnancy registry: Findings after 5 years of enrollment, 2003-2009

Susan S. Roberts, Richard K. Miller, Judith K. Jones, Karen L. Lindsay, Michael F. Greene, Willis C. Maddrey, Ian T. Williams, John Liu, Robert J. Spiegel

Research output: Contribution to journalArticle

40 Citations (Scopus)

Abstract

INTRODUCTION: Ribavirin, with interferons or pegylated interferons, is used to treat chronic hepatitis C. Ribavirin is contraindicated in pregnancy (FDA Pregnancy Category X) and in men whose partners may become pregnant. In 2003, the Ribavirin Pregnancy Registry was established to monitor pregnancy exposures to ribavirin and to evaluate the potential human teratogenicity of prenatal exposure. METHODS: This voluntary registry enrolls pregnant women who have been exposed to ribavirin during pregnancy or during the six months prior to conception either directly, by taking ribavirin, or indirectly through sexual contact with a man taking ribavirin. Women are followed until delivery; live born infants are followed for one year. The Registry aims to enroll 131 live births following direct (maternal) exposure to ribavirin and 131 live births following indirect (male) exposures. RESULTS: After more than five years of operation, the Registry has enrolled 49 live births with direct exposure and 69 live births following indirect exposure. Six outcomes with birth defects have been reported. All were among live born infants: torticollis (2), hypospadias (1), polydactyly and a neonatal tooth (1), glucose-6-phosphate dehydrogenase deficiency (1), ventricular septal defect and cyst of 4th ventricle of the brain (1). Three received direct exposures ([6.1% (95% CI: 1.2, 16.9)], three were exposed indirectly [4.3% (95% CI: 0.9, 12.2)]. CONCLUSIONS: Although current enrollment is far short of the required sample size, preliminary findings have not detected a signal indicating human teratogenicity for ribavirin. However, findings must be interpreted with caution concerning direct or indirect prenatal ribavirin exposures.

Original languageEnglish (US)
Pages (from-to)551-559
Number of pages9
JournalBirth Defects Research Part A - Clinical and Molecular Teratology
Volume88
Issue number7
DOIs
StatePublished - Jul 2010

Fingerprint

Ribavirin
Registries
Pregnancy
Live Birth
Interferons
Polydactyly
Glucosephosphate Dehydrogenase Deficiency
Fourth Ventricle
Maternal Exposure
Torticollis
Hypospadias
Ventricular Heart Septal Defects
Chronic Hepatitis C
Sample Size
Cysts
Pregnant Women
Tooth

ASJC Scopus subject areas

  • Developmental Biology
  • Pediatrics, Perinatology, and Child Health
  • Embryology
  • Medicine(all)

Cite this

The ribavirin pregnancy registry : Findings after 5 years of enrollment, 2003-2009. / Roberts, Susan S.; Miller, Richard K.; Jones, Judith K.; Lindsay, Karen L.; Greene, Michael F.; Maddrey, Willis C.; Williams, Ian T.; Liu, John; Spiegel, Robert J.

In: Birth Defects Research Part A - Clinical and Molecular Teratology, Vol. 88, No. 7, 07.2010, p. 551-559.

Research output: Contribution to journalArticle

Roberts, SS, Miller, RK, Jones, JK, Lindsay, KL, Greene, MF, Maddrey, WC, Williams, IT, Liu, J & Spiegel, RJ 2010, 'The ribavirin pregnancy registry: Findings after 5 years of enrollment, 2003-2009', Birth Defects Research Part A - Clinical and Molecular Teratology, vol. 88, no. 7, pp. 551-559. https://doi.org/10.1002/bdra.20682
Roberts, Susan S. ; Miller, Richard K. ; Jones, Judith K. ; Lindsay, Karen L. ; Greene, Michael F. ; Maddrey, Willis C. ; Williams, Ian T. ; Liu, John ; Spiegel, Robert J. / The ribavirin pregnancy registry : Findings after 5 years of enrollment, 2003-2009. In: Birth Defects Research Part A - Clinical and Molecular Teratology. 2010 ; Vol. 88, No. 7. pp. 551-559.
@article{652e1785648d43648d4f297a7e29c250,
title = "The ribavirin pregnancy registry: Findings after 5 years of enrollment, 2003-2009",
abstract = "INTRODUCTION: Ribavirin, with interferons or pegylated interferons, is used to treat chronic hepatitis C. Ribavirin is contraindicated in pregnancy (FDA Pregnancy Category X) and in men whose partners may become pregnant. In 2003, the Ribavirin Pregnancy Registry was established to monitor pregnancy exposures to ribavirin and to evaluate the potential human teratogenicity of prenatal exposure. METHODS: This voluntary registry enrolls pregnant women who have been exposed to ribavirin during pregnancy or during the six months prior to conception either directly, by taking ribavirin, or indirectly through sexual contact with a man taking ribavirin. Women are followed until delivery; live born infants are followed for one year. The Registry aims to enroll 131 live births following direct (maternal) exposure to ribavirin and 131 live births following indirect (male) exposures. RESULTS: After more than five years of operation, the Registry has enrolled 49 live births with direct exposure and 69 live births following indirect exposure. Six outcomes with birth defects have been reported. All were among live born infants: torticollis (2), hypospadias (1), polydactyly and a neonatal tooth (1), glucose-6-phosphate dehydrogenase deficiency (1), ventricular septal defect and cyst of 4th ventricle of the brain (1). Three received direct exposures ([6.1{\%} (95{\%} CI: 1.2, 16.9)], three were exposed indirectly [4.3{\%} (95{\%} CI: 0.9, 12.2)]. CONCLUSIONS: Although current enrollment is far short of the required sample size, preliminary findings have not detected a signal indicating human teratogenicity for ribavirin. However, findings must be interpreted with caution concerning direct or indirect prenatal ribavirin exposures.",
author = "Roberts, {Susan S.} and Miller, {Richard K.} and Jones, {Judith K.} and Lindsay, {Karen L.} and Greene, {Michael F.} and Maddrey, {Willis C.} and Williams, {Ian T.} and John Liu and Spiegel, {Robert J.}",
year = "2010",
month = "7",
doi = "10.1002/bdra.20682",
language = "English (US)",
volume = "88",
pages = "551--559",
journal = "Teratology",
issn = "1542-0752",
publisher = "Wiley-Liss Inc.",
number = "7",

}

TY - JOUR

T1 - The ribavirin pregnancy registry

T2 - Findings after 5 years of enrollment, 2003-2009

AU - Roberts, Susan S.

AU - Miller, Richard K.

AU - Jones, Judith K.

AU - Lindsay, Karen L.

AU - Greene, Michael F.

AU - Maddrey, Willis C.

AU - Williams, Ian T.

AU - Liu, John

AU - Spiegel, Robert J.

PY - 2010/7

Y1 - 2010/7

N2 - INTRODUCTION: Ribavirin, with interferons or pegylated interferons, is used to treat chronic hepatitis C. Ribavirin is contraindicated in pregnancy (FDA Pregnancy Category X) and in men whose partners may become pregnant. In 2003, the Ribavirin Pregnancy Registry was established to monitor pregnancy exposures to ribavirin and to evaluate the potential human teratogenicity of prenatal exposure. METHODS: This voluntary registry enrolls pregnant women who have been exposed to ribavirin during pregnancy or during the six months prior to conception either directly, by taking ribavirin, or indirectly through sexual contact with a man taking ribavirin. Women are followed until delivery; live born infants are followed for one year. The Registry aims to enroll 131 live births following direct (maternal) exposure to ribavirin and 131 live births following indirect (male) exposures. RESULTS: After more than five years of operation, the Registry has enrolled 49 live births with direct exposure and 69 live births following indirect exposure. Six outcomes with birth defects have been reported. All were among live born infants: torticollis (2), hypospadias (1), polydactyly and a neonatal tooth (1), glucose-6-phosphate dehydrogenase deficiency (1), ventricular septal defect and cyst of 4th ventricle of the brain (1). Three received direct exposures ([6.1% (95% CI: 1.2, 16.9)], three were exposed indirectly [4.3% (95% CI: 0.9, 12.2)]. CONCLUSIONS: Although current enrollment is far short of the required sample size, preliminary findings have not detected a signal indicating human teratogenicity for ribavirin. However, findings must be interpreted with caution concerning direct or indirect prenatal ribavirin exposures.

AB - INTRODUCTION: Ribavirin, with interferons or pegylated interferons, is used to treat chronic hepatitis C. Ribavirin is contraindicated in pregnancy (FDA Pregnancy Category X) and in men whose partners may become pregnant. In 2003, the Ribavirin Pregnancy Registry was established to monitor pregnancy exposures to ribavirin and to evaluate the potential human teratogenicity of prenatal exposure. METHODS: This voluntary registry enrolls pregnant women who have been exposed to ribavirin during pregnancy or during the six months prior to conception either directly, by taking ribavirin, or indirectly through sexual contact with a man taking ribavirin. Women are followed until delivery; live born infants are followed for one year. The Registry aims to enroll 131 live births following direct (maternal) exposure to ribavirin and 131 live births following indirect (male) exposures. RESULTS: After more than five years of operation, the Registry has enrolled 49 live births with direct exposure and 69 live births following indirect exposure. Six outcomes with birth defects have been reported. All were among live born infants: torticollis (2), hypospadias (1), polydactyly and a neonatal tooth (1), glucose-6-phosphate dehydrogenase deficiency (1), ventricular septal defect and cyst of 4th ventricle of the brain (1). Three received direct exposures ([6.1% (95% CI: 1.2, 16.9)], three were exposed indirectly [4.3% (95% CI: 0.9, 12.2)]. CONCLUSIONS: Although current enrollment is far short of the required sample size, preliminary findings have not detected a signal indicating human teratogenicity for ribavirin. However, findings must be interpreted with caution concerning direct or indirect prenatal ribavirin exposures.

UR - http://www.scopus.com/inward/record.url?scp=77954753594&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77954753594&partnerID=8YFLogxK

U2 - 10.1002/bdra.20682

DO - 10.1002/bdra.20682

M3 - Article

C2 - 20564430

AN - SCOPUS:77954753594

VL - 88

SP - 551

EP - 559

JO - Teratology

JF - Teratology

SN - 1542-0752

IS - 7

ER -