Long-term Effectiveness, Treatment Persistence, and Timing of Virological Failure With Long-Acting Cabotegravir Plus Rilpivirine in Real-World HIV Care: RELATIVITY Cohort
Luis Buzón, Noemí Cabello-Clotet, María Luisa Montes, María José Galindo, Rosa María Martínez, Mireia Santacreu, María Remedios-Alemán, Miguel Torralba, Francisco Fanjul, Manuel Gutiérrez-Cuadra, Adrián Rodríguez, María José Crusells, María Navarro, María Aguilera-García, Carmen Hidalgo-Tenorio, Luis Enrique Morano, David Vinuesa, Enrique Bernal-Morell, Carlos de Andrés, Hadrián Pernas, Juan Tiraboschi, Alejandro Bendala, María Jesús Vivancos, Cristina Díez, Guillermo Soria, Desiré Pérez, Mireia Cairó, Alberto Romero, Rebeca Cabo, Josefa Soler, María Antonia Sepúlveda, Joaquín Bravo, Cristina Escrich, Eva Ferreira, Beatriz Valentín, Magdalena Muelas, Ana Lucas-Dato, Albert Gómez, Ana Cerezales, Juan Emilio Losa, José Sanz, Mar Masía, Juan José Corte-García, Ana Antolí, Juan Carlos Gainzarain, Miriam Estébanez, Patricia Barragán, Marta Clavero, Óscar Ferrero, Jesús Troya, , Ana Cristina Antolí Royo, Carmen Grande Sáez, María Ángeles Garcinuño Jiménez, Ana Carrero Gras, Eva María Ferreira Pasos, Hadrian Pernas Pardavila, Mercedes González, Nuria Vázquez Temprano, Miriam Estébanez, Tatiana Mata-Forte, Ana Muñoz Gómez, Claudia Dorta Hernández, José Reynaldo Homen Fernández, Juncal Pérez-Somarriba Moreno, Maravillas Carralón, María José Núñez Orantos, María Nieves Sanz Pérez, Noemí Cabello-Clotet, Philip Erick Wickman Jorgensen, Susana Olmedo Hernández, Teresa Martínez Burgoa, Valeria Cabral Sousa, Vicente Estrada Pérez, Virginia Víctor Palomares, Ana Ferrer Ribera, Andreu Belmonte, Ángela Pradilla Dieste, Carolina Pinto, María José Galindo Puerto, Rosa Oltra Sempere, Sandra Pérez Gómez, Álvaro Cecilio, Isabel Sanjoaquín Conde, María José Crusells Canales, Pilar Jiménez Marcen, Ana Lucas Dato, Belén Martínez López, Inmaculada González Cuello, Jara Llenas García, María García López, Carolina Navarro, Luis Buzón Martín, María Fernández, Amparo Exojo Morales, Carlos de Andrés David, Inmaculada Poquet Catalá, Karenina Antelo Cuéllar, Laia Navarro Peiró, María Josefa de la Asunción Villaverde, Silvia Lope Bolumar, Alba León Barbosa, Esther Nogales Nieves, Eva García Alcalde, Juan José Corte García, Lucía Alonso Alonso, María Vanessa López Peláez, Sara Jaber Carballo, Albert Gómez Lozano, Sara García Torras, Marta Milián Sanz, Ana Isabel Lérida Urteaga, Antonia Pérez Barja, Javier López-Nieto Sempere, Magdalena Muelas Fernández, Beatriz de la Calle, Ángela Botella Zaragoza, Félix Gutiérrez Rodero, Javier García Abellán, Mar Masiá, Paula Mascarell Arlandis, Sergio Padilla Urrea, Chiara Fanciulli, Cristina Díez Romero, Francisco Tejerina Picado, Juan Carlos López Bernaldo de Quirós, Leire Pérez Latorre, María Teresa Aldamiz-Echevarría Lois, Antonio Jesús Sánchez Guirao, Ángeles Muñoz Pérez, Antonia Alcaraz García, Cristina Tomás Jiménez, Elena Guijarro Westermeyer, Enrique Bernal Morell, Eva García Villalba, Joaquín Bravo Urbieta, María Dolores Hernández Lorente, Rodrigo Martínez Rodríguez, Román González Hipólito, Noemí Patricia Barragán Gallo, Alberto Juárez Toquero, Beatriz Valentín Casado, Jesica Abadía Otero, Julia Gómez Barquero, Pablo Bachiller Luque, Yolanda Arranz García, Adriana Pinto, David Rial, Federico Pulido, Juan Martín, Laura Bermejo Plaza, María de Lagarde, María Teresa López Caballero, Mireia Santacreu, Otilia Bisbal, Rafael Rubio, Roser Navarro, Victoria Macheño del Real, Celia Miralles Álvarez, Guillermo Pousada, Henar de las Heras Miralles, Luis Enrique Morano Amado, Víctor Asensi, Laura Guio Carrión, Mikel del Álamo, Ester Sáez de Adana Arroniz, Juan Carlos Gainzarain Arana, Ana Vegas Serrano, Juan Emilio Losa García, María Velasco Arribas, Maite Ganchegui Aguirre, Miriam López Martínez, Óscar Luis Ferrero Benítez, Alicia Sedo Mor, Analuz Fernández, Juan Tiraboschi, Josefa Soler González, Víctor Arenas García, Lucía Romero, Nereyda Tosco García, Remedios Alemán Valls, Guillermo Soria Fernández-Llamazares, Juan Víctor San Martín López, Ruth Calderón Hernáiz, Alberto Delgado Fernández, Lorenzo Sánchez, Miguel Torralba González de Suso, Alberto Romero Palacios, María Antonia Sepúlveda, Alejandra Gimeno García, Alejandro David Bendala Estrada, Carmen Montero Hernández, Diana Corps Fernández, Jose Carlos Escribano, María del Mar García Navarro, Marouane Menchi Elanzi, Ana Cerezales Calviño, Bárbara Alonso Moreno, José Fernando Lluch Perales, Alfonso Cabello, Miguel Górgolas Hernández-Mora, María Rubio Olivera, Marta Clavero Olmos, Belén Escribano Losada, Guillermo Cuevas, Jesús Troya García, Mariano Matarranz, Pablo Ryan, Sandra Rodríguez Perut, Alejandro de Gea, Ana Belén Delgado Hierro, Carmen Busca, José Ignacio Bernardino, Juan González García, Luz Martín Carbonero, María del Mar Arcos Rueda, María Luisa Montes, Rafael Micán, Rocío Montejano, Andoni Casen Gil, Ignacio de los Santos, María Aguilera García, Aitziber Illaro Uranga, Carlos Armiñanzas Castillo, Claudia González-Rico, Francisco Arnaiz de las Revillas Almajano, Manuel Gutiérrez Cuadra, María Carmen Fariñas Álvarez, Noelia Ruiz-Alonso, Paula Runza, Raúl Parra-Fariñas, Ángela Forcén Vicente de Vera, María Aranzazú Caudevilla Martínez, Rosa María Martínez Álvarez, Ruth Caballero Asensio, David Dalmau Juanola, Laura Gisbert Pérez, Mireia Cairó Llobell, Roser Font Canals, Xavier Martínez Lacsa, José Sanz, Alberto Díaz de Santiago, Ana Fernández Cruz, Sara de la Fuente Moral, Ana Moreno, Daniel de las Heras Gómez, María Jesús Pérez Elías, María Jesús Vivancos Gallego, Mario Pons Guillén, Desiré Pérez Martínez, María Elisa Pino Díaz, Miguel Alberto de Zárraga Fernández, Miguel Vicente Egido Murciano, Teresa Omiste Sanvicente, Adrián Ferré, Antoni Campins, Francisco Fanjul, Luisa Martín Pena, Melchor Riera, Adrián Rodríguez, Patricia Sorní Moreno, Carmen Hidalgo Tenorio, Sergio Sequera Arquelladas, Cristina Escrich, María del Carmen Navarro, David Vinuesa, Noemí Cabello-Clotet, Paula Runza, David Vinuesa, Miguel Torralba, Francisco Fanjul, Adrián Rodríguez, Sonia Calzado, Luis Enrique Morano, Hadrián Pernas, Enrique BernalAbstract
Background
Long-acting injectable cabotegravir plus rilpivirine (CAB + RPV LA) is an established maintenance option for virologically suppressed people with human immunodeficiency virus-1 (HIV-1), but long-term real-world persistence and virological failure (VF) data remain limited.
Methods
RELATIVITY is an ongoing nationwide ambispective multicenter cohort of adults with HIV who switched from suppressive oral antiretroviral therapy to CAB + RPV LA in routine care in Spain. Data through 1 March 2026 were analyzed. The outcomes were virological suppression, treatment persistence, protocol-defined VF, and time to discontinuation-related events. Virological failure was defined as 2 consecutive HIV-1 RNA values ≥200 copies/mL or 1 value ≥500 copies/mL prompting discontinuation.
Results
Among 3349 participants, 3343 had valid follow-up dates; the median follow-up was 25.1 months (19.3–30.8). Virological suppression was documented in 3197/3349 (95.5%) overall and 3197/3309 (96.6%) with an evaluable closest viral load; 40 (1.2%) lacked an evaluable value. Injection adherence was ≥90% in 3257/3280 (99.3%) evaluable participants. Overall, 2979/3349 (89.0%) remained on CAB + RPV LA. Virological failure occurred in 28/3349 (0.8%); 20/28 (71.4%) occurred within the first 12 months after switching. Emergent integrase strand transfer inhibitor and/or nonnucleoside reverse transcriptase inhibitor resistance was detected in 19/28 VF cases, and 24/28 achieved virological suppression after switching to oral therapy. Treatment-limiting injection-site reactions and systemic adverse events occurred in 2.4% and 1.6%, respectively.
Conclusions
Long-acting injectable cabotegravir plus rilpivirine showed high virological suppression and persistence beyond 2 years in routine care. Virological failure was uncommon and clustered mainly within 12 months, supporting early virological monitoring and prompt resistance-guided management.