A total of 431 pregnancies occurred. The researchers found that pregnancy incidence did not differ significantly by study group, and that there was no statistically significant association between women receiving PrEP and those receiving placebo and the occurrence of pregnancy losses, which was 42.5 percent for women receiving FTC+TDF, 32.3 percent for those receiving placebo, and 27.7 percent for those receiving TDF alone. After July 2011 (when the placebo group was discontinued), the frequency of pregnancy loss was 37.5 percent for FTC+TDF and 36.7 percent for TDF alone.
Occurrence of preterm birth, congenital anomalies, kidney function and growth throughout the first year of life did not differ significantly for infants born to women who received PrEP vs placebo.
The authors write that for some outcomes, including pregnancy loss, preterm birth, congenital anomalies, and infant mortality, confidence intervals were wide (suggesting uncertainty in the result and the need for more data), including both a null effect and potential harm, and thus definitive statements about safety of PrEP in the periconception period cannot be made.
"These results should be discussed with HIV-uninfected women receiving PrEP who are considering becoming pregnant."
(doi:10.1001/jama.2014.8735; Available pre-embargo to the media at http://media.jamanetwork.com)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Editorial: Integrating HIV Prevention Into Practice
Bradley M. Mathers, M.B.Ch.B., M.D., and David A. Cooper, M.D., D.Sc., of the University of New South Wales, Sydney, Australia, comment on the findings of this study in an accompanying editorial.
" it appears (from the magnitude and asymmetry of t
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