Maintenance darunavir/ritonavir monotherapy to prevent perinatal HIV transmission, ANRS-MIE 168 MONOGEST study

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Mandelbrot, Laurent | Tubiana, Roland | Frange, Pierre | Peytavin, Gilles | Le Chenadec, Jérôme | Canestri, Ana | Morlat, Philippe | Brunet-Cartier, Cécile | Sibiude, Jeanne | Peretti, Delphine | Chambrin, Véronique | Chabrol, Amélie | Bui, Eida | Simon-Toulza, Caroline | Paul, Christelle | Delmas, Sandrine | Avettand-Fenoel, Véronique | Warszawski, Josiane | Capitant, Catherine | Fournier, Isabelle | Saillard, Juliette | Marchand, Lucie | Meyer Elie Azria, Laurence | Rouveix, Elisabeth | Goetghebuer, Tessa | Barin, Françis | Leroy, Valeriane | Arvieux, Cédric | Blanche, Stéphane | Dommergues, Marc A. | Guerin, Corinne | Pollard, Helène | Plantier, Jean Christophe | Avettand Fenoel, Veronique | Diallo, Alpha Ahmadou | Meier, Françoise | Floch, Corinne | Dommergues, Marc | Blanc, Christine | Selleret, Lise | Hessamfar, Mojgan Bonarek | Caldato, Sabrina | Houllier, Marie | Fourcade, Corinne | Letourneau, Alexandra | Clech, Laure | Chabrol, Amelie | Canon, Berengère | Granier, Michèle | Dollfus, Catherine | Brazet, Edith | Abbal, Julie | Matheron, Sophie | Bourgeois Moine, Agnès | Pannier, Emmanuelle | Marcou, Valérie | Medus, Marie | Wajszczak, Ilona | Genet, Philippe | Tordjeman, Nathalie | Brault, Dominique | Rami, Agathe | Maraux, Barbara | Bottero, Julie | Benbara, Amélie | Lachassine, Eric | Rosenthal, Éric | Naqvi, Alissa | Bongain, André | Monpoux, Fabrice | Cotte, Laurent | Huissoud, Cyril L. | Labaune, Jean Marc | Dupon, Michel | Roux, Denis | Elleau, Christophe | Duvivier, Claudine | Driessen, Marine | Avettand-Fenoel, Veronique | Gardiennet, Elise | Karmochkine, Marina | Zucman, David | Laperrelle, Juliette | Winer, Norbert | Reliquet, Véronique | Mambert, Marina | Levier, Axel | Ladjal, Hayette | Houel, Cleìa | Lebas, Barbara | Rahmoun, Manal | Eliette, Véronique | Resch, Martine | Arezes, Elisa

Edité par CCSD ; Oxford University Press (OUP) -

International audience. Objectives: Because NRTIs can have fetal toxicities, we evaluated a perinatal NRTI-sparing strategy to prevent perinatal HIV transmission. Our primary objective was to determine the proportion maintaining a viral load (VL) of <50 copies/mL up to delivery on darunavir/ritonavir monotherapy, without requiring treatment intensification.Methods: In a one-arm, multicentre Phase 2 clinical trial, eligible patients in the first trimester of pregnancy on ART with plasma VL<50 copies/mL received maintenance monotherapy with darunavir/ritonavir, 600/100 mg twice daily. VL was monitored monthly. ART was intensified in the case of VL>50 copies/mL. Neonates received nevirapine prophylaxis for 14 days.Results: Of 89 patients switching to darunavir/ritonavir monotherapy, 4 miscarried before 22 weeks' gestation, 2 changed treatment for elevated liver enzymes without virological failure, and 83 were evaluable for the main outcome. Six had virological failure confirmed on a repeat sample (median VL=193 copies/mL; range 78-644), including two before switching to monotherapy. In these six cases, ART was intensified with tenofovir disoproxil fumarate/emtricitabine. The success rate was 75/83, 90.4% (95% CI, 81.9%-95.7%) considering two patients with VL missing at delivery as failures, and 77/83, 92.8% (95% CI, 84.9%-97.3%) when considering them as successes since both had undetectable VL on darunavir/ritonavir throughout pregnancy. In ITT, the last available VL before delivery was <50 copies/mL in all of the patients. There was no case of perinatal HIV transmission.Conclusions: Darunavir/ritonavir maintenance monotherapy required intensification in nearly 10% of cases. This limits its widespread use, thus other regimens should be evaluated in order to limit exposure to antiretrovirals, particularly NRTIs, during pregnancy.

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