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Does Changing Antiretroviral Therapy in the First Trimester of Pregnancy for Safety Concerns Have an Impact on Viral Suppression?

Peyronnet, Violaine, MDa,b; Warszawski, Josiane, MD, PhDa,c,d; Sibiude, Jeanne, MD, PhDa,b,e; Dialla, Olivia, MCSa; Bourgeois-Moine, Agnès, MDf; Bui, Eida, MDg; Toulza, Caroline Simon, MDh; Peretti, Delphine, MDd; Brunet-Cartier, Cécile, MDi; Avettand-Fenoel, Véronique, MD, PhDj,k; Chenadec, Jérôme L., MD, PhDa; Faye, Albert, MD, PhDe,l; Tubiana, Roland, MDm; Mandelbrot, Laurent, MDa,b,e

JAIDS Journal of Acquired Immune Deficiency Syndromes: April 15, 2019 - Volume 80 - Issue 5 - p 574–584
doi: 10.1097/QAI.0000000000001954
Clinical Science

Objective: To determine whether changing antiretroviral therapy (ART) during pregnancy because of concern about fetal risks led to poorer virological outcomes.

Methods: All pregnancies in women with HIV-1 infection enrolled in the national multicenter prospective French Perinatal cohort at 14 week gestation or more were included between January 2005 and December 2015, if the mother was on ART at conception with a plasma viral load <50 copies/mL. The reasons for a change in the ART were analyzed according to treatment guidelines at the time of the pregnancy and defined as for safety concerns in the absence of reported maternal intolerance. Virological and pregnancy outcomes were studied by survival analysis and logistic regression adjusted for a propensity score established for each patient according to baseline characteristics.

Results: Of 7079 pregnancies in the overall cohort, 1797 had ART at conception with a viral load <50 copies/mL before 14 week gestation. Of these, 22 changed regimens in the first trimester for intolerance, and 411 of the remaining 1775 (23%) solely for safety concerns. The proportion of change was higher when the initial treatment was not recommended in the national guidelines (OR adjusted: 23.1 [14.0–38.2]), than when it was an alternative option (ORa: 2.2 [1.3–3.7]), as compared to recommended first-line regimens. Treatment changes for safety concerns did not lead to poorer virological control, compared with pregnancies without such changes (19.3% vs. 15.6%, HRa: 1.0 [0.7–1.4]).

Conclusions: Changing ART early in pregnancy to regimens considered safer for pregnancy, and neonatal health did not have a destabilizing effect on viral suppression.

aCESP INSERM U1018, AP-HP Hopital Bicètre, le Kremlin Bicètre, France;

bAP-HP Hôpital L. Mourier, Colombes;

cUniv Paris Sud, Le Kremlin-Bicêtre, France;

dAP-HP Hôpital Bicêtre, le Kremlin-Bicêtre, France;

eUniv Paris-Diderot, Paris, France;

fAP-HP Hôpital Bichat, Paris, France;

gAP-HP Hôpital Trousseau, Paris, France;

hCHU de Toulouse, Toulouse, France;

iCHU de Nantes, Nantes, France;

jAP-HP Hôpital Necker-Enfants Malades, Paris, France;

kUniv Paris-Descartes, Paris, France;

lAP-HP Hôpital R. Debré, Paris, France; and

mAP-HP Hôpital Pitié Salpétrière, Paris, France.

Correspondence to: Laurent Mandelbrot, MD, Service de Gynécologie-Obstétrique, Hôpital Louis Mourier, Université Paris-Diderot, 178 rue des Renouillers, 92700 Colombes, France (e-mail:

Supported by the French Agence Nationale de Recherche sur le SIDA (ANRS).

The authors have no conflicts of interest to disclose.

All authors contributed actively to the manuscript and approved the final version.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (

Received September 03, 2018

Accepted November 05, 2018

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.