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
University of North Carolina-Wilmington, 28403-5995, USA.
Birth Defects Res A Clin Mol Teratol. 2010 Jul;88(7):551-9. doi: 10.1002/bdra.20682.
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.
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.
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)].
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.
利巴韦林与干扰素或聚乙二醇化干扰素联合使用，用于治疗慢性丙型肝炎。利巴韦林在孕期禁用（美国食品药品监督管理局妊娠用药X类），对于其伴侣可能怀孕的男性也禁用。2003年，建立了利巴韦林妊娠登记处，以监测孕期暴露于利巴韦林的情况，并评估产前暴露的潜在人类致畸性。
这个自愿登记处招募在孕期或受孕前六个月内直接（通过服用利巴韦林）或间接（通过与服用利巴韦林的男性发生性接触）暴露于利巴韦林的孕妇。对这些女性进行随访直至分娩；对活产婴儿进行一年的随访。该登记处的目标是登记131例直接（母亲）暴露于利巴韦林后的活产儿以及131例间接（父亲）暴露后的活产儿。
经过五年多的运作，该登记处已登记49例直接暴露后的活产儿和69例间接暴露后的活产儿。已报告6例出生缺陷病例。所有病例均为活产婴儿：斜颈（2例）、尿道下裂（1例）、多指并生及新生牙（1例）、葡萄糖-6-磷酸脱氢酶缺乏症（1例）、室间隔缺损和脑第四脑室囊肿（1例）。3例为直接暴露[6.1%（95%可信区间：1.2，16.9）]，3例为间接暴露[4.3%（95%可信区间：0.9，12.2）]。
虽然目前登记的数量远低于所需样本量，但初步研究结果尚未发现表明利巴韦林具有人类致畸性的信号。然而，对于产前直接或间接暴露于利巴韦林的情况，研究结果必须谨慎解读。
