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The Journal of antimicrobial chemotherapy · 2025

A prospective assessment of the efficacy and durability of long-acting cabotegravir and rilpivirine in individuals with HIV in Spain (RELATIVITY study).

СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Buzón-Martín Luis, Montes Maria Luisa, Pedrero Roberto, Galindo María José, Santacreu-Guerrero Mireia, Alemán María Remedios, Torralba Miguel, Díaz de Santiago Alberto, Fanjul Fran, Rodríguez Adrián, Cabello Alfonso, Crusells María José, Navarro María Del Carmen, Aguilera María, Hidalgo-Tenorio Carmen, Morano-Amado Luis Emilio, Vinuesa David, De Andres Carlos, Bernal-Morell Enrique, Martínez-Álvarez Rosa María, Cabello-Clotet Noemí, Tiraboschi Juan, Montero María Del Carmen, Vivancos-Gallego María Jesús, Díez Cristina, Calderón Ruth, De Zárraga Miguel Alberto, Gisbert Laura, Romero-Palacios Alberto, Cabo Rebeca, Soler Josefa Francisca, Sepúlveda María Antonia, Sánchez-Guirao Antonio Jesús, Escrich Cristina, Arnaiz De Las Revillas Francisco, Ferreira Eva, Valentín Beatriz, Lérida Ana, Llenas-García Jara, Gómez Albert, Losa Juan Emilio, Alonso Bárbara, Sanz José, Masiá Mar, Pernas Hadrian, Corte Juan José, Garcinuño María Ángeles, Gainzarain Juan Carlos, Estébanez Miriam, García-Navarro María Del Mar, Barragán Patricia, Ramos Noemí, Clavero Marta, Millán Marta, Del Álamo Míkel, Egido Miguel, De La Calle Beatriz, Ferrero Oscar Luis, Troya Jesús

Аннотация

BACKGROUND: Daily oral antiretroviral therapy (ART) has transformed HIV into a chronic, manageable condition, but it still poses psychological, logistical, and biological challenges. Long-acting injectable (LAI) cabotegravir plus rilpivirine provides an alternative for virologically suppressed individuals, reducing treatment fatigue, stigma, and daily dosing. While clinical trials have demonstrated efficacy and safety, real-world data remain limited. We assessed the effectiveness and safety of LAI cabotegravir plus rilpivirine in Spain.

METHODS: RELATIVITY is a 5-year, multicentre, ambispective, non-controlled cohort study. The primary endpoint was treatment effectiveness, defined as the proportion of patients discontinuing LAI therapy for any reason, including loss of virological suppression (HIV-RNA >50 copies/mL) during follow-up, regardless of formal failure criteria.

RESULTS: This interim analysis (cut-off: March 1, 2025) included 3203 patients from 58 Spanish hospitals; 57 were excluded due to detectable viral load at switch, leaving 3146 participants. Most were men (84.6%), with a median age of 45 years. Median time on ART before switching was 9.0 (5.0-15.0) years, and duration of viral suppression was 84.0 (36.0-132.0) months. Prior integrase inhibitor-based regimens were reported in 77.1%. Virological suppression was maintained in ≥96% through 23 months of follow-up. Overall, 6.4% (n = 199) discontinued, most frequently for injection-site reactions (n = 45), systemic adverse events (n = 29), or virological failure (n = 20).

CONCLUSIONS: Interim results from the RELATIVITY cohort confirm high effectiveness and safety of LAI cabotegravir plus rilpivirine in Spanish clinical practice, consistent with randomized trial outcomes and real-world data. An extended follow-up will provide further insights.

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты