Rilpivirine in HIV-1-positive women initiating pregnancy: to switch or not to switch?
Authors: Frange Pierre , Tubiana Roland , Sibiude Jeanne , Canestri Ana , Arvieux Cédric , Brunet-Cartier Cécile , Cotte Laurent , Reynes Jacques , Mandelbrot Laurent , Warszawski Josiane , Le Chenadec Jérôme ,   ANRS EPF CO1/CO11 Study Group, Mandelbrot Laurent , Crenn-Hebert Catherine , Floch-Tudal Corinne , Mazy Fabienne , Joras Marine , Meier Françoise , Mortier Emmanuel , Briquet Catherine , Ichou Houria , Marty Laurence , Jabbarian Hélène , Ceccaldi Pierre-François , Villemant Agnès , Zarouk Virginie , Lefort Agnès , Ben Salah Mariam , Hittinger Gilles , Chamouilli Jean-Marc , Burle Christian , Lafeuillade Alain , Philip Gisèle , Lambry Véronique , Medus Marie , Bachelard Germaine , Malet Martine , Dendale-Nguyen Joëlle , Guimard Thomas , Guimard Karine , Brossier Jean-Pierre , Perré Philippe , Esnault Jean-Luc , Aubry Olivier , Leautez-Nainville Sophie , Bonnenfant Valerie , Laine Laeticia , Martha Sandrine-Anne , Maurel Elise , Françoise Michel , Barat Muriel , Murger Patricia , Rouha Mahfoud , Lévy Marc , Lumbroso Philippe , Checoury Alain , Sahadatu Osseni , Johnson Ama , Perfezou Pascale , Blondin Gilles , Duthé Jean-Charles , Ansart Séverine , De Saint Martin Luc , Le Moine Philippe , Duthé Jean-Charles , Daniel Corinne , Calvez Christian , Boutaric Emmanuelle , Rohan Jennifer , Arvieux Cédric , Bauville Estelle , Dupre Christelle , Lotton Pascal , Ouamara-digue Enora , Poinsignon Yves , Goussef Marie , Grelier Anne , Mousset Gaetane , Cudeville Corinne , Mouton-Rioux Virginie , Niault Mathilde , Belzic Isabelle , Moreau Philippe , Le Coz Marie-Françoise , Vaillant Odile Luycx , Guerin-Duplessy Anne , Mouton-Rioux Virginie , De Morel Philippe , Vitrat Virginie , Tardif Didier , Gaillat Jacques , Vanderbergh Anne , Braig Suzanne , Clavere Gaelle , Dehlinger-Paul Marion , Mohamed Khaled , Echard Marie , Camus Michel , Mulard Catherine , Fontelonga Marie-Agnès , Heller-Roussin Brigitte , Winter Cécile , Challier Marion , Debruyne Elise , Marcou Valerie , Firtion Ghislaine , Pannier Emmanuelle , Costa Myriam , Launay Odile , Salmon-Ceron Dominique , Belkacem Touria , Bajawi Youcef , Aubret Valérie Raynal , Rivaux Danièle , Matheron Sophie , Elaoun Neila , Allal Lahcene , Djoubou Sandrine , Rahli Djamila , Moine Agnès Bourgeois , Valentin Morgane , Damond Florence , Huri Virginie , Vivier Valérie , Yahia Fatma Ait , Garrait Valérie , Hau Isabelle , Touboul Claudine , Ratsimbazafy Lanto , Boiron Emilie , Elharrar Brigitte , Richier Laurent , Cotte Laurent , Labaune Jean-Marc , Rudigoz René-Charles , Brochier Corinne , Galvan Valérie , Ogoudjobi Stanislas , Elleau Christophe , Runel-Belliard Camille , Pistone Thierry , Fleury Hervé , Horovitz Jacques , Sandler Boris , Roux Denis , Ragnaud Jean-Marie , Chabanier Pierre , Brun Jean-Luc , Delveaux Sandrine , Muanza Blandine , Diallo Mama Doufari , Lamaury Isabelle , Sow Marie-Thérèse , Samar Ketty , Carpentier Bénédicte , Osman Zafer , Dienga Etienne , Seaume Hervé , Ducrocq Sarah , Bailly-Salin Philippe , Da Silva Christelle Dusart , Fayolas Isabelle , Abbal Julie , Simon-Toulza Caroline , Truillet Véronique , Bogner Noëlle , Chiabrando Julie , Armand Evelyne , Cayla Claudine , Chacé Anne , Matheron Isabelle , Richier Laurent , Miantezila Joe , Bry Sandrine , Couderc Sophie , Narcy Catherine , Routier Corinne , Nassar Rania , Bouldouyre Marie-Anne , Zakaria Ahmed , Dauphin Hélène , Goissen Céline , Belloy Marie , Delassus Jean-Luc , Favret Véronique , Nemeth Céline , Partisani MariaLuisa , Entz-Werle Natacha , Langer Bruno , Uettwiller Françoise , Durand Myriam , Partizani MariaLuisa , Cheneau Christine , Rey David , Ebel Edith , Fischer Patricia , David Eric , Vayssiere Christophe , Weil Michèle , Schmitt Marie Paule , Nisand Israël , Genet Philippe , Brault Dominique , Allisy Christine , Gerbe Juliette , Masse Virginie , Wifaq Bouchra , Courdavault Laurence , Gabor Petra , Tordjeman Nathalie , Lebrette Marie-Gisèle , Selleret Lise , Samama Déborah , Vaudre Geneviève , Bolot Pascal , Khuong-Josses Marie-Aude , Amel Mahdi , Bounan Stéphane , Nourry Christelle , Andris Sabine , Blanche Stéphane , Driessen Marine , Frange Pierre , Veber Florence , Fischer Alain , Rouzioux Christine , Avettand-Fenoel Véronique , Mahlaoui Nizar , Mourey Marie-Christine , Granier Michèle , Devidas Alain , Donnadieu Anne-Claire , May Adrien , Chabrol Amélie , Chevojon Pierre , Bellahcene Chahrazede , Sanchez Audrey , Malbrunot Claire , Neizelien Joelle , Agher Nouara , Pluchart Claire , Rouger Christine , Tubiana Roland , Dommergues Marc , Bonmarchand Manuela , Shneider Luminata , Caby Fabienne , Calin Ruxandra-Oana , Blanc Christine , Lupin Catherine , Pauchard Michèle , Yangui Mohamed Amine , Roca Didier , Todorova Darina , 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 , Allouche Claude , Pathe Jean-Paul , Lachassine Eric , Benoist Laurence , Jeantils Vincent , Delannoy Catherine , Benbara Amélie , Carbillon Lionel , Borgne Anne , Moreau Laurence , Picard Fabienne , Karaoui Leïla , Elbert Véronique Lefevre , Balaz Valérie , Bongain André , Monpoux Fabrice , Deville Anne , Galiba Eliane , Jabbar Ahmed , Joutel Martine , Schmidt Jean-Luc , Decaux Nathalie , Cravello Ludovic , Errichiello Katia , Hubert Claire , Dollfus Catherine , Hervé François , Tabone Marie-Dominique , Courcoux Mary-France , Leverger Guy , Kayem Gilles , Schnurgier Aurélie , Jensen Aurore , Vaudre Geneviève , Pinquier Didier , Gromez Alexis , Pinto-Cardoso Gaelle , Faye Albert , Borie Constance , Levine Martine , Matheron Sophie , Marouts Erianna Bellaton , Boissinot Christine , Caseris Marion , Pommelet Virginie , Morau Geneviève , Leveille Sandrine , Boumediene Marie Astride , Garion Dominique , Peretti Delphine , Fourcade Corinne , Houllier Marie , Jrad Ikram , Bourdic Katia , Monnier Sylvie , Chirouze Catherine , Proust Aurélie , Catteau Odile , Gardiennet Quentin , Reliquet Véronique , Brunet-Cartier Cécile , Winer Norbert , Vaucel Edouard , Rodallec Audrey , Garnier-André Elisabeth , Briandet Claire , Brouard Jacques , Goubin Pascale , Beucher Gaël , Dina Julia , Demersay Arnaud Chalvon , Tassi Sylvie , Lavarenne Gaelle , Rajguru Mandovi , Messaoudi Fabienne , Carre Nathalie , Rajguru Mandavi , Bobrie-Moyrand Claire , Foucaud Pierre , Bernard Louis , Maakroun Zoha , Bourgault Olivier , Kebaïli Kamila , Bertrand Yves , Alixe Véronique , Boyer Emeline , Billiemaz Kareen , Fanget Cécile , Ronat Véronique , Lesauder Catherine , Lavastre Marie Laure , Moulin Alice , Turquini Marie-France , Colombani Dominique , Belgodere Danièle , Fialaire Pascale , Proust Stéphanie , Rehaiem Sami , Mesnard Louis , Werner Evelyne , Dukiel Nathalie , Desmergers Baya , Blanc-Ruffat Isabelle , Maraux Barbara , Coursol Anne , Castaneda Julie , Etienne Lise , Vintejoux Emmanuelle , Lalande Muriel , Reynes Jacques , Segondy Michel , Guigue Nelly , De Gennes Christiane , Clavel Cyril , Cazassus François , Walter Véronique , Mazingue Françoise , Hammou Yamina , Lagree Marion , Paquiez Odile , D’angelo Sophie , Ajana Faiza , Boquet Laurence , Ajana Faïza , Hatchuel Yves , Nahri Imad , Zebelus Jenny , Genet Claire , Ducroix-Roubertou Sophie , Aubrard Yves , Constanty Anne , Weinbreck Pierre , Piet Emilie , Jacquier Françoise , Michaud Christophe , Safwan Hassan , Boutet Arnaud , Grand-Courault Carole , Autret Fanny , Habibi Fakher , Azria Elie , Abdelhadi Mohamed , Elenga Narcisse , Bocket Laurence , Taillet Françoise , Palenzuela Gilles , Khadly Redouane , Pierronnet Danielle , Dos-Santos Emmanuelle , David Selva , Makhloufi Djamila , Brunel-Dalmas Florence , Carbonnel-Delalande Elisabeth , Chiarello Pierre , Godinot Matthieu , Gilbert Sylvie , Massardier Jérôme , Gauthier-Moulinier Hélène , Fernandes Elisabeth , Ranaivojaona Sata , Chevry Coralie 
Published: January 2020

Background

Safety data about rilpivirine use during pregnancy remain scarce, and rilpivirine plasma concentrations are reduced during second/third trimesters, with a potential risk of viral breakthroughs. Thus, French guidelines recommend switching to rilpivirine-free combinations (RFCs) during pregnancy.

Objectives

To describe the characteristics of women initiating pregnancy while on rilpivirine and to compare the outcomes for virologically suppressed subjects continuing rilpivirine until delivery versus switching to an RFC.

Methods

In the ANRS-EPF French Perinatal cohort, we included women on rilpivirine at conception in 2010–18. Pregnancy outcomes were compared between patients continuing versus interrupting rilpivirine. In women with documented viral suppression (&lt;50 copies/mL) before 14 weeks of gestation (WG) while on rilpivirine, we compared the probability of viral rebound (≥50 copies/mL) during pregnancy between subjects continuing rilpivirine versus those switching to RFC.

Results

Among 247 women included, 88.7% had viral suppression at the beginning of pregnancy. Overall, 184 women (74.5%) switched to an RFC (mostly PI/ritonavir-based regimens) at a median gestational age of 8.0 WG. Plasma HIV-1 RNA nearest delivery was &lt;50 copies/mL in 95.6% of women. Among 69 women with documented viral suppression before 14 WG, the risk of viral rebound was higher when switching to RFCs than when continuing rilpivirine (20.0% versus 0.0%, P = 0.046). Delivery outcomes were similar between groups (overall birth defects, 3.8/100 live births; pregnancy losses, 2.0%; preterm deliveries, 10.6%). No HIV transmission occurred.

Conclusions

In virologically suppressed women initiating pregnancy, continuing rilpivirine was associated with better virological outcome than changing regimen. We did not observe a higher risk of adverse pregnancy outcomes.