Effectiveness and tolerability of dolutegravir/lamivudine for the treatment of HIV-1 infection in clinical practice

Author:

Suárez-García Inés123ORCID,Alejos Belén4,Hernando Victoria25,Viñuela Laura67,Vera García Mar8,Rial-Crestelo David29ORCID,Pérez Elías María Jesús210ORCID,Albendín Iglesias Helena1112,Peraire Joaquim21314,Tiraboschi Juan15ORCID,Díaz Asunción25,Moreno Santiago210ORCID,Jarrín Inma216,Moreno Santiago,Jarrín Inma,Dalmau David,Navarro M Luisa,González M Isabel,Garcia Federico,Poveda Eva,Iribarren Jose Antonio,Gutiérrez Félix,Rubio Rafael,Vidal Francesc,Berenguer Juan,González Juan,Muñoz-Fernández M Ángeles,Jarrín Inmaculada,Moreno Cristina,Rava Marta,Izquierdo Rebeca,del Romero Raposo Jorge,Marco Cristina,Puente Julián,Muñoz-Fernández M Ángeles,Mauleón Elba,Juárez Roxana,Portilla Joaquín,Portilla Irene,Merino Esperanza,García Gema,Agea Iván,Sánchez-Payá José,Rodríguez Juan Carlos,Giner Livia,Reus Sergio,Boix Vicente,Torrus Diego,Pérez Verónica,Portilla Julia,Alemán María Remedios,Hernández Jehovana,Lirola Ana López,García Dácil,Díaz-Flores Felicitas,Alonso M Mar,Pelazas Ricardo,Asensi Víctor,Rivas M Eugenia,Suarez-Zarracina Tomás,Valle-Garay Eulalia,Díaz Javier,Pulido Federico,Rubio Rafael,Bisbal Otilia,Hernando M Asunción,Rial David,de Lagarde María,Arce Octavio,Pinto Adriana,Bermejo Laura,Santacreu Mireia,Navarro Roser,Gonzalez Candela,Iribarren Jose Antonio,Aramburu M José,Camino Xabier,von Wichmann Miguel Ángel,Goenaga Miguel Ángel,Bustinduy M Jesús,Azkune Harkaitz,Ibarguren Maialen,Kortajarena Xabier,Álvarez-Rodriguez Ignacio,Gil Leire,Martínez Lourdes,Gutiérrez Félix,Masiá Mar,Robledano Catalina,Padilla Sergio,Abellán Javier Garcia,Mascarell Paula,Adsuar Araceli,Pascual Rafael,Carvajal Mar,Fernández Marta,García José Alberto,Botella Ángela,de la Rica Alba,Ding Carolina,García-Sánchez Lidia,Ena Nuria,Barber Xavier,Agullo Vanessa,Pascual Reyes,Telenti Guillermo,Guillén Lucia,López Leandro,Vallejo Jennifer,Gonzalo-Jimenez Nieves,Ruiz Montserrat,Galiana Antonio,Muga Roberto,Sanvisens Arantza,Fuster Daniel,de Quirós Juan Carlos López Bernaldo,Gutierrez Isabel,Ramírez Margarita,Padilla Belén,Gijón Paloma,Aldamiz-Echevarría Teresa,Tejerina Francisco,Diez Cristina,Pérez Leire,Fanciulli Chiara,Corral Saray,Peraire Joaquín,Martí Anna,Viladés Consuelo,Vargas Montserrat,Olona Montserrat,Rull Anna,Alba Verónica,Yeregui Elena,Masip Jenifer,García-Pardo Graciano,Bertomeu Frederic Gómez,Espineira Sonia,Montero Marta,Blanes Marino,Tasias María,Calabuig Eva,Salavert Miguel,Fernández Juan,Segarra Inmaculada,González-García Juan,Delgado-Hierro Ana,Arribas José Ramón,Arribas Victor,Bernardino Jose Ignacio,Busca Carmen,Cano Joanna,Cadiñanos Julen,Castro Juan Miguel,Escosa Luis,Falces Iker,Herranz Pedro,Hontañón Victor,García Milagros,González-Baeza Alicia,Martín-Carbonero M Luz,Mayoral Mario,Mellado Mª Jose,Micán Rafael,de Miguel Rosa,Montejano Rocío,Montes M Luisa,Moreno Victoria,Rodés Luis Ramos Berta,Sainz Talía,Sendagorta Elena,Valencia Eulalia,Blanco Jose Ramón,Pérez-Martínez Laura,Oteo José Antonio,Ibarra Valvanera,Metola Luis,Sanz Mercedes,Martínez Rosa,Sampériz Gloria,Dalmau David,Martinez Marina,Jaén Angels,Cairó Mireia,Martinez-Lacasa Javier,Font Roser,Gisbert Laura,Rivero María,Piérola Beatriz,Goikoetxea Maider,Gracia María,Ibero Carlos,Moreno Estela,Repáraz Jesús,Navarro Gemma,Garcia Manel Cervantes,Isbert Sonia Calzado,Vilasaro Marta Navarro,Garcia Belen Lopez,de los Santos Ignacio,de los Santos Alejandro,Sanz Jesús,García-Fraile Lucio,Martín Enrique,Sánchez-Cerrillo Ildefonso,Calvet Marta,Barrios Ana,Bautista Azucena,Sáez Carmen,Ciudad Marianela,Gutiérrez Ángela,Moreno Santiago,del Campo Santos,Casado José Luis,Dronda Fernando,Moreno Ana,Pérez M Jesús,Serrano Sergio,Vivancos M Jesús,Martínez-Sanz Javier,Vallejo Alejandro,Sanchez Matilde,Pérez-Molina Jose Antonio,Hermida José Manuel,Bernal Enrique,Alcaraz Antonia,Bravo Joaquín,Muñoz Ángeles,Tomás Cristina,Martínez Mónica,Villalba M Carmen,García Federico,Martínez Clara,Hernández José,Medina Leopoldo Muñoz,Álvarez Marta,Chueca Natalia,Vinuesa David,de Salazar Adolfo,Fuentes Ana,Guirao Emilio,Viñuela Laura,Ruiz-Sancho Andrés,Anguita Francisco,Del Romero Jorge,Raposo Montserrat,Rodríguez Carmen,Puerta Teresa,Carrió Juan Carlos,Vera Mar,Ballesteros Juan,Ayerdi Oskar,Baza Begoña,Orviz Eva,Antela Antonio,Losada Elena,Riera Melchor,Peñaranda María,Ribas M Angels,Campins Antoni A,Garcia-Gazalla Mercedes,Fanjul Francisco J,Murillas Javier,Homar Francisco,Vilchez Helem H,Martin Luisa,Payeras Antoni,Santos Jesús,López María,Gómez Cristina,Viciana Isabel,Palacios Rosario,López-Cortés Luis Fernando,Espinosa Nuria,Roca Cristina,Llaves Silvia,Tiraboschi Juan Manuel,Imaz Arkaitz,Silva Ana Karina,Saumoy María,Scévola Sofía Catalina,Curran Adrián,Falcó Vicenç,Navarro Jordi,Burgos Joaquin,Suanzes Paula,García Jorge,Descalzo Vicente,Álvarez Patricia,Planas Bibiana,Sanchiz Marta,Rodríguez Lucía,Olalla Julián,Sánchez M José,Pérez Javier,del Arco Alfonso,de la Torre Javier,Prada José Luis,Martínez Onofre Juan,Martinez Lorena,Vera Francisco Jesús,García Josefina,Alcaraz Begoña,Guirao Antonio Jesús Sánchez,Mena Álvaro,Castro Ángeles,Pernas Berta,Vázquez Pilar,López Soledad,Ibarra Sofía,García Guillermo,Mirena Josu,Ferrero Oscar Luis,López Josefina,Cámara M Mar,de la Peña Mireia,Lopez Miriam,Lopez Iñigo,Lombide Itxaso,Polo Victor,de Miguel Joana,Galera Carlos,Fernández Marian,Albendin Helena,Castillo Antonia,Iborra Asunción,Moreno Antonio,Merlos M Angustias,Vidal Asunción,Amador Concha,Pasquau Francisco,Gil Concepción,Algado Jose Tomás,Suarez-García Inés,Malmierca Eduardo,González-Ruano Patricia,Ruiz M Pilar,Pascual José Francisco,Balsalobre Luz,Somodevilla Ángela,López M Villa,Omar Mohamed,Herrero Carmen,Gómez M Amparo,de Zarraga Miguel Alberto,Pérez Desiré,Estrada Vicente,Sanz Nieves,Cabello Noemí,Vergas Jorge,Núñez M Jose,Sagastagoitia Iñigo,Homen Reynaldo,Muñoz Ana,Górgolas Miguel,Cabello Alfonso,Álvarez Beatriz,Prieto Laura,Carrillo Irene,Al-Hayani Aws,Sanz José,Arranz Alberto,Hernández Cristina,Novella María,Galindo M José,Ferrer Ana,Román Antonio Rivero,Ruíz Inma,Juárez Antonio Rivero,López Pedro,Machuca Isabel,Frías Mario,Camacho Ángela,Pérez Ignacio,Corona Diana,Pérez Ignacio,Corona Diana,Cervero Miguel,Torres Rafael,Sánchez Juan Macías,Rincón Pilar,Real Luis Miguel,Corma Anais,Fernández Marta,González-Serna Alejandro,Poveda Eva,Pérez Alexandre,Morano Luis,Miralles Celia,Ocampo Antonio,Pousada Guillermo,Patiño Lucía,Dueñas Carlos,Gutiérrez Sara,Tapia Elena,Novoa Cristina,Egües Xjoylin,Telleria Pablo,

Affiliation:

1. Infectious Diseases Group, Department of Internal Medicine, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN , Madrid , Spain

2. CIBER de Enfermedades Infecciosas (CIBERINFEC) , Madrid , Spain

3. Department of Medicine, Universidad Europea , Madrid , Spain

4. Independent Researcher , Madrid , Spain

5. HIV, STI and Hepatitis Surveillance Unit, National Center of Epidemiology, Institute of Health Carlos III , Madrid , Spain

6. Department of Microbiology, Hospital Universitario Clínico San Cecilio , Granada , Spain

7. Instituto de Investigación Biosanitaria Granada , Granada , Spain

8. Centro Sanitario Sandoval, IdISSC, Hospital Clínico San Carlos , Madrid , Spain

9. David Rial-Crestelo, HIV Unit, Hospital Universitario 12 de Octubre-Imas12 , Madrid , Spain

10. Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, IRYCIS , Madrid , Spain

11. HIV and STI Unit, Department of Internal Medicine, Hospital Universitario Virgen de la Arrixaca , Murcia , Spain

12. Instituto Murciano de Investigación Biosanitaria (IMIB) , Murcia , Spain

13. Hospital Universitari de Tarragona Joan XXIII, IISPV , Tarragona , Spain

14. Universitat Rovira i Virgili , Tarragona , Spain

15. HIV Unit, Department of Infectious Diseases, Hospital Universitari de Bellvitge, Hospitalet de Llobregat , Barcelona , Spain

16. National Centre of Epidemiology, Institute of Health Carlos III , Madrid , Spain

Abstract

Abstract Objectives To assess the effectiveness and tolerability of dolutegravir (DTG)/lamivudine (3TC) among treatment-naive and virologically suppressed treatment-experienced individuals in the multicentre cohort of the Spanish HIV/AIDS Research Network (CoRIS) during the years 2018–2021. Methods We used multivariable regression models to compare viral suppression (VS) [HIV RNA viral load (VL) <50 copies/mL] and the change in CD4 cell counts at 24 and 48 (±12) weeks after initiation with dolutegravir/lamivudine or other first-line ART regimens. Results We included 2160 treatment-naive subjects, among whom 401 (18.6%) started with dolutegravir/lamivudine. The remaining subjects started bictegravir (BIC)/emtricitabine (FTC)/tenofovir alafenamide (TAF) (n = 949, 43.9%), DTG + FTC/tenofovir disoproxil fumarate (TDF) (n = 282, 13.1%), DTG/3TC/abacavir (ABC) (n = 255, 11.8%), darunavir (DRV)/cobicistat(COBI)/FTC/TAF (n = 147, 6.8%) and elvitegravir (EVG)/COBI/FTC/TAF (n = 126, 5.8%). At 24 and 48 weeks after starting dolutegravir/lamivudine, 91.4% and 93.8% of the subjects, respectively, achieved VS. The probability of achieving VS with dolutegravir/lamivudine was not significantly different compared with any other regimen at 24 or 48 weeks, with the exception of a lower chance of achieving VS at 24 weeks for DRV/COBI/FTC/TAF (adjusted OR: 0.47; 95% CI: 0.30–0.74) compared with dolutegravir/lamivudine. For the analysis of treatment-experienced virally suppressed subjects we included 1456 individuals who switched to dolutegravir/lamivudine, among whom 97.4% and 95.5% maintained VS at 24 and 48 weeks, respectively. During the first 48 weeks after dolutegravir/lamivudine initiation, 1.0% of treatment-naive and 1.5% of treatment-experienced subjects discontinued dolutegravir/lamivudine due to an adverse event. Conclusions In this large multicentre cohort, effectiveness and tolerability of dolutegravir/lamivudine were high among treatment-naive and treatment-experienced subjects.

Funder

Instituto de Salud Carlos III

Red Temática de Investigación Cooperativa en Sida

ISCIII-Subdirección General de Evaluación

Fondo Europeo de Desarrollo Regional

ViiV Healthcare

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology,Microbiology (medical)

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