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No difference in pregnancy outcomes found among women on PrEP
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There were no differences in pregnancy incidence, birth outcomes or infant growth among serodiscordant couples in which HIV-negative women were receiving pre-exposure prophylaxis, or PrEP, according to new data.
“However, given that the confidence intervals for the birth outcomes were wide, definitive statements about the safety of PrEP in the periconception period cannot be made,” researchers from the department of global health at the University of Washington, wrote in JAMA. “These results should be discussed with HIV-uninfected women receiving PrEP who are considering becoming pregnant.”
As part of the Partners PrEP study, 1,785 HIV-negative female partners of serodiscordant heterosexual couples were randomly assigned to tenofovir (Viread, Gilead Sciences), combination tenofovir/emtricitabine (Truvada, Gilead Sciences) or placebo. The women underwent pregnancy tests each month and discontinued treatment in the event of pregnancy for the duration of pregnancy and breast-feeding. As a secondary objective of the Partners PrEP study, the researchers evaluated pregnancy data and birth outcomes among women who became pregnant while taking PrEP.
There were 413 pregnancies during the study period. Through July 2011, when the placebo treatment group was discontinued, there were 288 pregnancies and no difference in incidence between the three groups. Ninety-six of the pregnancies resulted in pregnancy loss. By group, 42.5% of pregnancies in the tenofovir/emtricitabine group were lost compared with 32.3% in the placebo group and 27.7% in the tenofovir group.
After July 2011, there were 143 pregnancies and no difference in incidence between the remaining two groups. Fifty-two of the pregnancies resulted in loss. The frequency of pregnancy loss was 37.5% for tenofovir/emtricitabine and 36.7% for tenofovir alone.
The researchers found no difference in the occurrence of preterm birth, congenital anomalies or growth throughout the first year of life among the infants born.
“The desire for pregnancy among serodiscordant couples is often great and can override fear of HIV transmission associated with conception attempts,” the researchers wrote. “Our findings provide additional evidence to support the option of periconception administration of antiretroviral PrEP for HIV-uninfected women in both high- and low-income populations, along with other strategies such antiretroviral treatment of their HIV-infected partners and limiting unprotected sex to peak fertility periods to reduce the risk of sexual transmission of HIV.”
Disclosure: Gilead Sciences donated the medication for this study.
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