Advertisement

TheBodyPRO.com Covers CROI 2017

News

No Increase in Adverse Birth Outcomes With Maternal TDF/FTC in U.S. Study

February 23, 2017

Among pregnant women with HIV in the U.S., use of tenofovir, emtricitabine, lopinavir/ritonavir (TDF/FTC/LPV/r) was not associated with increased risk of adverse infant birth outcomes when compared to zidovudine, lamivudine, LPV/r (AZT/3TC/LPV/r) or TDF, FTC, atazanavir/ritonavir (TDF/FTC/ATV/r).

In the PROMISE trial, infants of women randomized to TDF/FTC/LPV/r had elevated risk of very preterm birth, very low birth weight, and death compared to those randomized to AZT/3TC/LPV/r.

Data from two large prospective U.S. cohort studies (IMPAACT P1025 and PHACS ) were used to compare risk of adverse birth outcomes for infants with in utero exposure to AZT/3TC/LPV/r, TDF/FTC/LPV/r, and TDF/FTC/ATV/r. The results from this comparison were shown at CROI 2017.

Exposure was classified by first regimen used during pregnancy. The investigators evaluated the risk of the following outcomes: preterm (<37 weeks) and very preterm (<34 weeks) birth, low (<2,500 g) and very low (<1,500 g) birth weight, composite adverse and severe adverse outcomes (outcomes above plus foetal loss, infant mortality).

Of 4,646 enrolled infants, 128 (2.8%), 539 (11.6%) and 954 (20.5%) had mothers who received TDF/FTC/LPV/r, TDF/FTC/ATV/r and AZT/3TC/LPV/r respectively. Table 1 shows risk of outcomes by initial ART regimen.


Table 1. Risk of Outcomes by Initial ART Regimen in Pregnancy
Initial Regimen TDF/FTC/LPV/r TDF/FTC/ATV/r AZT/3TC/LPV/r
Preterm birth 27 (21.4%) 86 (16.1%) 184 (19.5%)
Very preterm birth 5 (4.0%) 26 (4.9%) 44 (4.7%)
Low birth weight 30 (23.8%) 86 (16.2%) 175 (18.8%)
Very low birth weight 1 (0.8%) 10 (1.9%) 18 (1.9%)
Adverse outcome 36 (28.1%) 127 (23.7%) 256 (27.2%)
Severe adverse outcome 7 (5.5%) 28 (5.2%) 51 (5.4%)


In crude and adjusted analyses, the investigators found TDF/FTC/LPV/r was not associated with adverse birth outcomes compared to AZT/3TC/LPV/r or TDF/FTC/ATV/r. The study was underpowered to evaluate severe outcomes. TDF/FTC/LPV/r use in pregnancy was uncommon in the two large U.S. cohorts.


Reference

Rough K et al. TDF/FTC in pregnancy shows no increase in adverse infant birth outcomes in U.S. cohorts. 24th Conference on Retroviruses and Opportunistic Infections (CROI 2017), 13-16 February 2017, Poster abstract 779.
www.croiconference.org/sessions/tdfftc-pregnancy-shows-no-increase-adverse-infant-birth-outcomes-us-cohorts (abstract and poster)


Related Stories

Women on Lopinavir/Ritonavir-Based Regimens at Conception at Higher Risk of Preterm Delivery in UK Study



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.
 


No comments have been made.
 

Add Your Comment:
(Please note: Your name and comment will be public, and may even show up in
Internet search results. Be careful when providing personal information! Before
adding your comment, please read TheBody.com's Comment Policy.)

Your Name:


Your Location:

(ex: San Francisco, CA)

Your Comment:

Characters remaining:


Please note: Knowledge about HIV changes rapidly. Note the date of this summary's publication, and before treating patients or employing any therapies described in these materials, verify all information independently. If you are a patient, please consult a doctor or other medical professional before acting on any of the information presented in this summary. For a complete listing of our most recent conference coverage, click here.

Advertisement

The content on this page is free of advertiser influence and was produced by our editorial team. See our content and advertising policies.