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Learning Objective:
By the end of the presentation, participants will be able to:
Reinforce pregnancy prevention in women and men using ribavirin
Describe the importance of monitoring pregnancy exposures to ribavirin
Refer exposed pregnant women to the Ribavirin Pregnancy Registry (RPR)
Background:
Ribavirin has significantly improved treatment outcomes in patients with chronic HCV when combined with alpha interferon. However, ribavirin is teratogenic in animal models; teratogenicity in human is unclear. Despite product label warnings, pregnancies continue to occur in women exposed to ribavirin. As requested by the FDA, ribavirin manufacturers are conducting the RPR to evaluate birth defect risk primarily, following direct ribavirin exposure and secondarily, following indirect ribavirin exposure.
Setting:
Operated in the US, the RPR is a call center-based registry collecting data by phone, fax, and mail from health care providers (HCPs) and patients.
Population e.g. API Youth, MSM, IDU:
The Registry enrolls pregnant women following direct exposure (i.e., female taking ribavirin during or 6 months prior to pregnancy) or indirect exposure (i.e., through sexual contact with a male taking ribavirin during or 6 months prior to pregnancy).
Project Description:
The RPR is a prospective, observational, exposure-registration and follow-up study. Exposed women are followed throughout pregnancy; their infants are followed for 1 year.
Results/Lessons Learned:
A unique feature of RPR is the inclusion of male exposures in the evaluation of birth defect risk. Enrollment is ongoing as the current sample size is insufficient to evaluate risk. Enrollment has recently benefited by the implementation of a waiver of documentation of informed consent (US 21 CFR 56.109(c)(1)). However, achieving sufficient live births may be complicated by interferon's abortifacient effects. The Registry's success relies on patients and HCPs who report ribavirin pregnancy exposures and assist in obtaining pregnancy outcome and postnatal information on live birth outcomes. For more information, contact RPR: 800-593-2214 or www.RibavirinPregnancyRegistry.com
Web Page: www.RibavirinPregnancyRegistry.com
See more of Poster Session #2
See more of The 2005 National Viral Hepatitis Prevention Conference