A Call for Participation in the Ribavirin Pregnancy Registry

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A Call for Participation in the Ribavirin Pregnancy Registry

L. , MD, Associate Professor of MedicineGastroenterology and Liver DiseaseKeck School of MedicineHepatitis Research & Treatment CenterUniversity of Southern CaliforniaLos Angeles, California

Chronic hepatitis C virus (HCV) infection is the leading cause of death from liver disease in the United States. According to recent estimates by the Centers for Disease Control and Prevention (CDC), 3.9 million Americans have been infected with HCV and among those nearly 70% are chronically infected; however, many individuals remain unaware of their infection. Fortunately, the number of new infections per year is on the decline, from 240,000 new cases reported in 1988 to 30,000 cases reported in 2003. This decline is largely attributable to implementation of blood donor screening in the late 1980s and new virus inactivation procedures used for plasma-derived products. Despite this downward trend, the prevention and treatment of HCV infection still remains a major public health concern.

To date, there is no HCV vaccination available and the current treatment of choice for HCV infection is the use of pegylated interferon in combination with the oral nucleoside ribavirin. This treatment results in sustained viral clearance in more than 50% of treated patients as well as improvements in liver histology.

Although ribavirin has proven effective in the treatment of HCV, it is currently contraindicated for use during pregnancy because of the teratogenic and/or embryocidal effects observed in animals exposed to ribavirin. Currently, no data are available for human fetal exposure to ribavirin and the potential risk of birth defects can only be extrapolated from animal data.

Ribavirin is labeled by the US Food and Drug Administration (FDA) as Pregnancy Category X, which warns against its use by female patients or by male patients with female partners who are or may become pregnant during treatment or during the 6 months following ribavirin therapy. Despite these warnings, ribavirin exposure during pregnancy does occur, and there is little or no information available for physicians on how to best counsel women regarding pregnancy outcome. Patients should be advised to notify their physicians immediately in the event of a pregnancy and to report the pregnancy to the Ribavirin Pregnancy Registry.

In 2001, the CDC reported the prevalence of chronic HCV infection to be highest among adults of reproductive age—those 25-45 years of age. Thus, the likelihood of exposure to ribavirin during a pregnancy has the potential to be high and warrants the need for human data regarding embryo and fetal ribavirin exposure.

To assess the actual risk of birth defects due to ribavirin exposure during pregnancy, a public health program, known as the Ribavirin Pregnancy Registry, has been initiated postlabel by the FDA. This is a voluntary program developed to assess outcomes of pregnancies exposed to ribavirin either by direct maternal exposure or by indirect paternal exposure. The Registry board strongly encourages and invites physicians who are currently treating or who have previously treated patients exposed to ribavirin while pregnant to participate in this registry. More information regarding this registry and ways to participate can be found at www.ribavirinpregnancyregistry.com or by calling the registry at 800-593-2214.

The Registry’s aim is to collect prospective observational data on pregnancies and pregnancy outcomes to determine actual risk of ribavirin exposure. Retrospective data are also being collected and analyzed. The overall objectives of the Registry are to 1) determine associations between birth defects and ribavirin exposed pregnancies, 2) estimate the risk of major birth defects following ribavirin exposure, and 3) detect any increase in the prevalence or pattern of birth defects following ribavirin exposure.

The types of data collected include demographics, family history, status of HCV infection, ribavirin exposure information, and prenatal tests. In addition, outcome data such as gestational age, sex, anthropometric measurements, APGAR score, and any identifiable birth defects will be collected. Assessment occurs at each trimester, at outcome, and during the first 12 months of infant development. Data collected by the Registry will be summarized and published twice per year in a Registry Interim Report that will be reported to the FDA.

To ensure the success of the Ribavirin Pregnancy Registry, patients and physicians are needed to report ribavirin-exposed pregnancies and to collect data during pregnancy and following pregnancy outcome. This Registry will undoubtedly help physicians in managing patient care and in assessing risk of birth defects in ribavirin-exposed pregnancies.

Reference

Centers for Disease Control and Prevention. Viral hepatitis C. Available at:

http://www.cdc.gov/ncidod/diseases/hepatitis/c/index.htm. Accessed April 4, 2006.

http://clinicaloptions.com/Hepatitis/Resources/News%20and%20Comment/Expert%20Viewpoints/March%202006.aspx