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PREP in Pregnancy Does Not Increase Poor Birth Outcomes

April 2017

No increase in poor birth outcomes with PrEP used throughout pregnancy in the Partners Demonstration project reported at CROI 2017.

There are limited safety data to guide the use of PrEP in pregnancy and women are currently counselled with the option to continue or discontinue it during this period.

Birth outcomes from infants exposed to FTC/TDF PrEP throughout pregnancy in the open label Partners Demonstration PrEP study, conducted in Kenya and Uganda, were compared with unexposed infants born to women randomised to placebo who became pregnant in the Partners PrEP Study (comparator).

Of 334 women receiving PrEP, 30 became pregnant and continued its use. Of 621 women receiving placebo, 79 became pregnant (85 pregnancies).

Women in the PrEP exposed and unexposed groups were a median of 25 and 28 years respectively and had a median of two children before study entry.

The investigators reported similar pregnancy outcomes in PrEP-exposed and un-exposed pregnancies. See Table 1.

Table 1: Pregnancy Outcomes PrEP Exposed vs Unexposed Infants
PrEP-Exposed PrEP-Unexposed OR (95% CI) p-Value
Preterm delivery 0 5 (7.7%) 0.4 (0 to 2.3) p=0.4
Pregnancy loss 5 (16.7%) 20 (23.5%) 0.8 (0.3 to 2.5) p=0.7
Congenital anomaly 0 5 (7.7%) Fisher's exact p=0.3

They also reported that infant growth characteristics were similar at 12 months and any early detriment in PrEP exposed infants appeared to catch up by this time.


Data from this small cohort of PrEP exposed babies provide some reassurance that PrEP can be used safely throughout pregnancy.


Heffron R et al. PrEP used in pregnancy does not increase poor birth outcomes.CROI 2017. 13-16 February 2017. Seattle, Washington. Poster abstract 934. (abstract and poster)

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This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.

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