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TENOFOVIR DF IN PREGNANCY: FINDINGS FROM THE ANTIRETROVIRAL PREGNANCY REGISTRY (APR)
R Brown1, D Goodwin2, S Zhang2, E Fagan2
1Columbia University, New York, New York; 2Gilead Sciences, Foster City, California, USA
Aims: Tenofovir disoproxil fumarate (TDF) was licensed in 2001 for the treatment of HIV-1 infection. TDF (Viread) received approval in Canada, US and Europe in 2008 for the treatment of chronic hepatitis B virus (HBV) infection with pregnancy FDA Category B designation.
Methods: The APR is a prospective international registry of voluntary reports to detect major teratogenic effects involving antiretrovirals (ARVs) and anti-HBV drugs administered to pregnant women. Founded in 1989, the APR enrolls ~900 pregnant women/year in US and Canada (~14% of live births to HIV-1 infected women). Numbers of 1st trimester exposures to 11 ARVs, including TDF, are sufficient to detect at least a 2-fold increase in overall birth defects.
Results: Data on TDF exposure in pregnant women (800 live births, most to women with HIV-1 infection and in combination with other ARVs) are captured in the APR. Through January 31, 2008, in 11,209 prospective cases including 98 HIV/HBV co-infected patients and 78 patients with HBV mono-infection reported to the APR (9,400 live births), no overall increase in congenital anomalies in infants following any trimester ARV exposure has been observed, compared to the general population.
Conclusions: Congenital anomaly rates are comparable to those from the CDC population-based birth defects surveillance system (2.72/100 live births). Health care providers are encouraged to report exposures to ARVs and HBV drugs, including TDF, in pregnant women to the APR.