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Pregnancy Outcomes Among ART-Naive and ART-Experienced HIV-Positive Women: Data From the ICONA Foundation Study Group, Years 1997–2013

d'Arminio Monforte, Antonella MD*; Galli, Laura PhD; Lo Caputo, Sergio MD; Lichtner, Miriam MD§; Pinnetti, Carmela MD; Bobbio, Nicoletta MD; Francisci, Daniela MD#; Costantini, Andrea MD**; Cingolani, Antonella MD††; Castelli, Francesco MD‡‡; Girardi, Enrico MD§§; Castagna, Antonella MDfor the ICONA Foundation Study Group

JAIDS Journal of Acquired Immune Deficiency Syndromes: November 1st, 2014 - Volume 67 - Issue 3 - p 258–267
doi: 10.1097/QAI.0000000000000297
Clinical Science

Background: We analyzed antiretroviral therapy (ART) regimens and pregnancy outcomes in naive and ART-experienced HIV-positive women from Italian Cohort Naive Antiretrovirals cohort and investigated frequency and predictors of detectable viral load (VL) at delivery.

Methods: All pregnancies resulting in live births were included. Based on ART at the beginning of pregnancy, pregnancies were allocated either to the ART-naive or ART-experienced group. Analyses were stratified according to calendar periods. Multivariate logistic regression was used to describe predictors of detectable VL at delivery.

Results: One hundred fifty-eight of 2862 women experienced 169 pregnancies (88 in naives and 81 in 70 ART-experienced women). ART regimens varied according to calendar periods; mono–dual combination regimens progressively decreased over time (P value for trend <0.0001). Protease inhibitor–including regimens were the most frequently used regimens at delivery (71.6% vs 63.0% in naives and in ART experienced, P = 0.2). VL was detectable in 35.6% of women at delivery; this was less likely with increasing calendar periods (adjusted odds ratio per 1-year longer: 0.8, 95% confidence interval: 0.7 to 0.9, P = 0.007) and more likely in women with HIV RNA >50 copies per milliliter at pregnancy ascertainment (adjusted odds ratio: 7.1, 95% confidence interval: 1.9 to 33.3, P = 0.006). Nevertheless, no cases of vertical transmission were diagnosed. Preterm birth rate of 17.3% (11.9% vs 22.6% naive and ART experienced, P = 0.1) was reported; this was not associated with ART duration or protease inhibitor–including regimens; 27.2% of infants had <2500 g birth weight.

Conclusions: Antiretroviral regimens prescribed during pregnancy changed over time according to guidelines. Although undetectable VL was not always achieved, no vertical transmission occurred; preterm delivery and low birth weight occurred in some cases and still remain key issues.

*Department of Health Sciences, Clinic of Infectious and Tropical Diseases, University of Milan, Milan, Italy;

Infectious Diseases, San Raffaele Hospital, Milan, Italy;

Infectious Diseases, Bagno a Ripoli Hospital, Florence, Italy;

§Department of Health and Infectious Diseases, University La Sapienza, Polo Pontino, Rome, Italy;

Infectious Diseases, INMI “L. Spallanzani,” I.R.C.C.S, Rome, Italy;

Infectious Diseases, Galliera Hospital, Genova, Italy;

#Infectious Diseases, University of Perugia, Perugia, Italy;

**Clinical Immunology, University of Ancona, Ancona, Italy;

††Infectious Diseases, University Sacro Cuore, Rome, Italy;

‡‡Division of Infectious and Tropical Diseases, Spedali Civili, University of Brescia, Brescia, Italy; and

§§INMI “L. Spallanzani,” I.R.C.C.S, Epidemiology, Rome, Italy.

Correspondence to: Antonella d'Arminio Monforte, MD, Department of Health Sciences, Institute of Infectious and Tropical Diseases, San Paolo University Hospital, Via A Di Rudinì 8, 20142 Milan, Italy (e-mail:

ICONA Foundation Study is sponsored by unrestricted grants from AbbVie, Briston Myers-Squibb, Gilead, Jannsen, Merck Sharp & Dohme, and ViiV Italy.

The authors have no conflicts of interest to disclose.

Presented in part at the 14th European AIDS Conference, October 16–19, 2013, Brussels, Belgium.

The members of the ICONA Foundation Study Group are listed in Appendix 1.

Received March 25, 2014

Accepted June 26, 2014

© 2014 by Lippincott Williams & Wilkins