| Title: |
In Utero Exposure to Zidovudine and Heart Anomalies in the ANRS French Perinatal Cohort and the Nested PRIMEVA Randomized Trial |
| Authors: |
Sibiude, Jeanne; Le Chenadec, Jérôme; Bonnet, Damien; Tubiana, Roland; Faye, Albert; Dollfus, Catherine; Mandelbrot, Laurent; Delmas, Sandrine; Lelong, Nathalie; Khoshnood, Babak; Warszawski, Josiane; Blanche, Stéphane; for the French National Agency for Research on AIDS and Viral Hepatitis French Perinatal Cohort/Protease Inhibitor Monotherapy Evaluation Trial; Crenn-Hebert, Catherine; Floch-Tudal, Corinne; Mazy, Fabienne; Joras, Marine; Meier, Françoise; Mortier, Emmanuel; Briquet, Catherine; Duro, Dominique; Ichou, Houria; Marty, Laurence; Ceccaldi, Pierre-François; Banige, Maïa; Uludag, Agnès Villemant; Zarouk, Virginie; Lefort, Agnès; Ben Salah, Mariam; Hittinger, Gilles; Chamouilli, Jean-Marc; Burle, Christian; Lafeuillade, Alain; Philip, Gisèle; Medus, Marie; Bachelard, Germaine; Malet, Martine; Dendale-Nguyen, Joëlle; Guimard, Thomas; Guimard, Karine; Brossier, Jean-Pierre; Perré, Philippe; Esnault, Jean-Luc; Stragier, Olivier Bollengier; Leautez-Nainville, Sophie; Suaud, Isabelle; Martha, Sandrine-Anne; Martha, Benoît; Maurel, Elise; Françoise, Michel; Barat, Muriel; Murger, Patricia; Rouha, Mahfoud; Lumbroso, Philippe; Checoury, Alain; Perfezou, Pascale; Blondin, Gilles; Duthé, Jean-Charles; Ansart, Séverine; Martin, Luc De Saint; Le Moine, Philippe; Daniel, Corinne; Calvez, Christian; Boutaric, Emmanuelle; Rohan, Jennifer; Arvieux, Cédric; Bauville, Estelle; Dupre, Christelle; Lotton, Pascal; Ouamara-digue, Enora; Poinsignon, Yves; Grelier, Anne; Mousset, Gaetane; Cudeville, Corinne; Mouton-Rioux, Virginie; Niault, Mathilde; Belzic, Isabelle; Moreau, Philippe; Le Coz, Marie-Françoise; Vaillant, Odile Luycx; De Morel, Philippe; Vitrat, Virginie; Tardif, Didier; Gaillat, Jacques; Vanderbergh, Anne; Braig, Suzanne; Clavere, Gaelle; Dehlinger-Paul, Marion; Mohamed, Khaled; Echard, Marie; Camus, Michel; Heller-Roussin, Brigitte; Winter, Cécile; Benveniste, Elyane; Firtion, Ghislaine; Pannier, Emmanuelle; Costa, Myriam; Launay, Odile; Ceron, Dominique Salmon; Belkacem, Touraia; Matheron, Sophie; Elaoun, Neila; Allal, Lahcene; Moine, Agnès Bourgeois; Bodard, Marylène; Damond, Florence; Huri, Virginie; Garrait, Valérie; Hau, Isabelle; Touboul, Claudine; Ratsimbazafy, Lanto; Kommé, Christiane; Elharrar, Brigitte; Richier, Laurent; Cotte, Laurent; Labaune, Jean-Marc; Rudigoz, René-Charles; Brochier, Corinne; Ogoudjobi, Stanislas; Elleau, Christophe; Runel-Belliard, Camille; Pistone, Thierry; Delveaux, Sandrine; Muanza, Blandine; Diallo, Mama Doufari; Sow, Marie-Thérèse; Samar, Ketty; Osman, Zafer; Carpentier, Bénédicte; Dienga, Etienne; Partisani, MariaLuisa; Entz-Werle, Natacha; David, Eric; Rey, David; Seaume, Hervé; Ducrocq, Sarah; Bailly-Salin, Philippe; de San Pedro, Christine; Tricoire, Joëlle; Berrebi, Alain; Simon-Toulza, Caroline; Truillet, Véronique; Chiabrando, Julie; Armand, Evelyne; Cayla, Claudine; Chacé, Anne; Matheron, Isabelle; Miantezila, Joe; Bry, Sandrine; Couderc, Sophie; Armangaud, Didier; Narcy, Catherine; Routier, Corinne; Nassar, Rania; Questiaux, Elisabeth; Zakaria, Ahmed; Dauphin, Hélène; Goissen, Céline; Belloy, Marie; Delassus, Jean-Luc; Favret, Mme; Cheneau, Christine; Lang, Jean-Marie; Genet, Philippe; Brault, Dominique; Allisy, Christine; Gerbe, Juliette; Masse, Virginie; Wifaq, Bouchra; Courdavault, Laurence; Gabor, Petra; Tordjeman, Nathalie; Lebrette, Marie-Gisèle; Selleret, Lise; Hervé, François; Samama, Déborah; Vaudre, Geneviève; Bolot, Pascal; Khuong-Josses, Marie-Aude; Ekoukou, Dieudoné; Bounan, Stéphane; Ghibaudo, Nelly; Andris, Sabrine; Lemercier, Delphine; Frange, Pierre; Veber, Florence; Fisher, Alain; Mourey, Marie-Christine; Granier, Michèle; Devidas, Alain; Donnadieu, Anne-Claire; Nguyen, Rose; May, Adrien; Chabrol, Amélie; Chevojon, Pierre; Moussa, Zaitoun Abdallah; Sanchez, Audrey; Malbrunot, Claire; Neizelien, Joelle; Agher, Nouara; Pluchart, Claire; Rouger, Christine; Bonmarchand, Manuela; Shneider, Luminata; Caby, Fabienne; Calin, Ruxandra-Oana; Bourse, Patricia; Lupin, Catherine; Coursol, Anne; Laurent, Juliette; Ferry, A; Deschaud, Martine; Blum, Laurent; Chambrin, Véronique; Labrune, Philippe; Clech, Laure; Raho-Moussa, Mariem; Pauly-Ravelly, Isolde; Jault, Thierry; Bouabdallah, Soufiane; Sanchez, Lydie; Sanchez, Anita; Johnson, Ama; Louchard, Agnès; Lachassine, Eric; Benoist, Laurence; Jeantils, Vincent; Gaudelus, Joel; Benbara, Amélie; Borgne, Anne; Karaoui, Leïla; Elbert, Véronique Lefevre; Balaz, Valérie; Bongain, André; Monpoux, Fabrice; Deville, Anne; Galiba, Eliane; Doumet, Antoine; Joutel, Martine; Schmidt, Jean-Luc; Decaux, Nathalie; Cravello, Ludovic; Errichiello, Katia; Hubert, Claire; Tabone, Marie-Dominique; Courcoux, Mary-France; Leverger, Guy; Carbonne, Bruno; Schnurgier, Aurélie; Jensen, Aurore; Pinquier, Didier; Clavier, Brigitte; Pinto-Cardoso, Gaelle; Levine, Martine; Marouts, Erianna Bellaton; Borie, Constance; Boissinot, Christine; Leveille, Sandrine; Boumediene, Marie Astride; Peretti, Delphine; Fourcade, Corinne; Colmant, Claire; Bourdic, Katia; Chirouze, Catherine; Mauvais, Cécile Hafner; Catteau, Odile; Gardiennet, Quentin; Reliquet, Véronique; Brunet-Cartier, Cécile; Winer, Norbert; Vaucel, Edouard; Rodallec, Audrey; Garnier-André, Elisabeth; Briandet, Claire; Brouard, Jacques; Goubin, Pascale; Demersay, Arnaud Chalvon; Tassi, Sylvie; Lavarenne, Gaelle; Hentgen, Véronique; Messaoudi, Fabienne; Carre, Nathalie; Rajguru, Mandovi; Kebaïli, Kamila; Billiemaz, Kareen; Fanget, Cécile; Ronat, Véronique; Abrudan, Ramona; Moulin, Alice; Fialaire, Pascale; Proust, Stéphanie; Rehaim, Sami; Arsac, Philippe; Mesnard, Louis; Werner, Evelyne; Dukiel, Nathalie; Desmergers, Baya; Ciraru-Vigneron, Nicole; Mouchnino, Geneviève; Ayral, Dominique; Keltoumi, Nora; Falgairou, Vincent; Vintejoux, Emmanuelle; Lalande, Muriel; Reynes, Jacques; Segondy, Michel; De Gennes, Christiane; Clavel, Cyril; Cazassus, François; Walter, Véronique; Mazingue, Françoise; Hammou, Yamina; Paquiez, Odile; D'angelo, Sophie; Ajana, Faiza; Boquet, Laurence; Ajana, Faïza; Hatchuel, Yves; Nahri, Imad; Zebelus, Jenny; Genet, Claire; Ducroix-Roubert, Sophie; Aubrard, Yves; Constanty, Anne; Weinbreck, Pierre; Piet, Emilie; Jacquier, Françoise; Robert, Julie; Michaud, Christophe; Safwan, Hassan; Boutet, Arnaud; Grand-Courault, Carole; Autret, Fanny; Habibi, Fakher; Azria, Elie; Abdelhadi, Mohamed; Elenga, Narcisse; Bocket, Laurence; Taillet, Françoise; Perilhou, Anais; Rachas, Antoine; Rouzioux, Christine |
| Publisher Information: |
Oxford University Press |
| Publication Year: |
2015 |
| Collection: |
HighWire Press (Stanford University) |
| Subject Terms: |
HIV/AIDS |
| Description: |
Background. Antiretroviral (ARV) regimens during pregnancy are highly effective in preventing mother-to-child transmission of human immunodeficiency virus (HIV). Congenital heart defects (CHDs) and anomalies in cardiac function have been reported in zidovudine (ZDV)–exposed uninfected children. We explored these associations in a large observational cohort and a randomized clinical trial. Methods. Since 1986, the French Perinatal Cohort prospectively enrolled all HIV-infected women in 90 centers and collected follow-up on their children through 2 years of age. All CHDs were reviewed by a specialist blinded to exposures. Additionally, in a randomized trial (PRIMEVA ANRS 135) of 2 ARV regimens during pregnancy, 1 of which was without nucleoside reverse transcriptase inhibitors, infants had a specific follow-up including echocardiography at 1 month and 12 months. Results. Among 12 888 children included, ZDV exposure in the first trimester was significantly associated with CHD (1.5% vs 0.7%; adjusted odds ratio, 2.2 [95% confidence interval, 1.3–3.7]; P < .001). This association was significant for ventricular septal defects (1.1% vs 0.6%; P = .001) and other CHDs (0.31% vs 0.11%; P = .02). In the randomized trial, among 50 infants, girls (but not boys) exposed in utero to ZDV/lamivudine/ritonavir-boosted lopinavir (LPV/r) had a higher left ventricular shortening fraction at 1 month (40% vs 36%; P = .008), and an increased posterior wall thickness at 1 year (5.4 mm vs 4.4 mm; P = .01) than the LPV/r group. Conclusions. This study confirms a specific association between in utero exposure to ZDV and CHDs, and a long-lasting postnatal myocardial remodeling in girls. A potential common mechanism, including the involvement of mitochondrial dysfunction, must be explored, and long-term consequences on cardiac function warrant specific attention. Clinical Trials Registration. NCT00424814. |
| Document Type: |
text |
| File Description: |
text/html |
| Language: |
English |
| Relation: |
http://cid.oxfordjournals.org/cgi/content/short/61/2/270; http://dx.doi.org/10.1093/cid/civ260 |
| DOI: |
10.1093/cid/civ260 |
| Availability: |
http://cid.oxfordjournals.org/cgi/content/short/61/2/270; https://doi.org/10.1093/cid/civ260 |
| Rights: |
Copyright (C) 2015, Infectious Diseases Society of America |
| Accession Number: |
edsbas.ABBDF179 |
| Database: |
BASE |