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Pre-exposure prophylaxis for HIV prevention does not improve pregnancy outcomes

Clinical Question:
Does antiretroviral pre-exposure prophylaxis improve pregnancy outcomes in HIV-serodiscordant heterosexual couples?

Bottom Line:
Pre-exposure antiretroviral prophylaxis to prevent HIV virus acquisition among HIV-serodiscordant heterosexual couples did not result in any significant differences in pregnancy incidence, birth outcomes, and infant growth. (LOE = 1b-)

Mugo NR, Hong T, Celum C, et al, for the Partners PrEP Study Team. Pregnancy incidence and outcomes among women receiving preexposure prophylaxis for HIV prevention. A randomized clinical trial. JAMA 2014;312(4):362-371.  [PMID:25038355]

Study Design:
Randomized controlled trial (double-blinded)



Outpatient (any)

Antiretroviral pre-exposure prophylaxis prevents HIV acquisition in heterosexual and homosexual serodiscordant couples. It remains uncertain if it improves pregnancy outcomes when given to heterosexual HIV-serodiscordant couples. Between July 2008 and November 2010, these investigators enrolled 4747 heterosexual HIV-serodiscordant couples from 9 sites in Kenya and Uganda in a randomized (uncertain allocation concealment) 3-group trial comparing oral tenofovir disoproxil fumarate (300 mg daily), emtricitabine/tenofovir disoproxil fumarate (200 mg/300 mg daily), or matched placebo. At enrollment HIV-infected partners did not meet guidelines for initiation of antiretroviral therapy (CD4 count < 350 cells/uL or symptomatic HIV-1 disease). Because of the demonstration of the efficacy and safety of pre-exposure prophylaxis in preventing HIV acquisition, in July 2011 study participants originally assigned to placebo were offered rerandomization to 1 of the 2 active pre-exposure prophylaxis groups. Women underwent monthly testing for pregnancy and study medication was discontinued after a positive test result for the duration of pregnancy and breastfeeding. The estimated exposure time to study medication in the event of pregnancy was approximately 6 weeks or less. Monthly HIV testing also continued throughout pregnancy and breastfeeding, and women seroconverting to HIV received referral for initiation of antiretroviral therapy and were pulled from the study. Live-born infants were observed for the first year of life. Follow-up retention remained greater than 95% for the duration of the study. During the primary, placebo-controlled analysis period, 288 pregnancies occurred among 267 HIV-uninfected women for an overall pregnancy incidence of 10.3 per 100 person-years. Pregnancy incidence did not differ significantly between the 3 treatment groups. Using intention-to-treat analysis, no significant differences occurred between the 2 active treatment groups and the placebo group in pregnancy losses, preterm births, or congenital anomalies. An additional 143 pregnancies occurred after the placebo group was discontinued in July 2011. The overall occurrence of adverse pregnancy outcomes remained not statistically different between the 2 pre-exposure prophylaxis groups. There were also no significant groups differences in overall infant mortality or indices suggesting growth retardation.


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