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Publications

Clinical Trial Journal Article Epublish

PubMed: 42921238 DOI: 10.1093/ofid/ofag583

Immune Trajectories After Switch to Long-Acting Cabotegravir Plus Rilpivirine in the RELATIVITY Cohort.

Open Forum Infect Dis 13(10):ofag583

Authors: Jesús Troya, Noemí Cabello-Clotet, José Ignacio Bernardino, María José Galindo, Rosa María Martínez, Juan Martín, María Remedios Alemán, Miguel Torralba, Francisco Fanjul, María Carmen Fariñas, Adrián Rodríguez, María José Crusells, Sonia Calzado, Javier Pérez-Serrano, Carmen Hidalgo-Tenorio, Luis Enrique Morano, David Vinuesa, Enrique Bernal-Morell, Inmaculada Poquet-Catalá, Hadrián Pernas-Pardavila, Juan Tiraboschi, Diana Corps, María Jesús Vivancos, Luis Buzón-Martín

Affiliations

  • Hospital Universitario Infanta Leonor, Madrid, Spain.
  • Hospital Universitario Clínico San Carlos, Madrid, Spain.
  • Hospital Universitario La Paz, Madrid, Spain.
  • Hospital Clínico Universitario de Valencia, Valencia, Spain.
  • Hospital Universitario Miguel Servet, Zaragoza, Spain.
  • Hospital Universitario 12 de Octubre, Madrid, Spain.
  • Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.
  • Hospital Universitario de Guadalajara, Guadalajara, Spain.
  • Hospital Universitari Son Espases, Palma de Mallorca, Spain.
  • Hospital Universitario Marqués de Valdecilla, Santander, Spain.
  • Hospital Universitario Son Llatzer, Palma de Mallorca, Spain.
  • Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
  • Consorci Corporació Sanitaria Parc Taulí, Sabadell, Barcelona, Spain.
  • Medicina Interna. Hospital Universitario La Princesa, Madrid, Spain.
  • Hospital Universitario Virgen de las Nieves, Granada, Spain.
  • Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain.
  • Hospital Universitario Clínico San Cecilio, Granada, Spain.
  • Hospital General Universitario Reina Sofía, Murcia, Spain.
  • Hospital Universitario de Denia-Marina Salud, Alicante, Spain.
  • Complexo Hospitalario Universitario de Pontevedra, Pontevedra, Spain.
  • Hospital Universitario de Bellvitge, Barcelona, Spain.
  • Hospital Universitario de Torrejón, Madrid, Spain.
  • Hospital Universitario Ramón y Cajal, Madrid, Spain.
  • Hospital Universitario de Burgos, Burgos, Spain.

Abstract

BACKGROUND

Immune and virological trajectories after switching to long-acting cabotegravir plus rilpivirine (CAB+RPV LA) remain incompletely characterized in routine care settings.

METHODS

We analyzed virologically suppressed adults switching to CAB+RPV LA in the Spanish multicenter RELATIVITY cohort. Paired CD4+, CD8+, and CD4/CD8 measurements were assessed at approximately 12 and 24 months and at the last available immune assessment. Analyses used a 1.0 ratio threshold and incorporated longitudinal HIV-1 RNA, recorded geographic origin, pre-switch suppression duration, and immediate pre-switch antiretroviral therapy.

RESULTS

Among 3349 participants, the last paired-ratio assessment (n = 2929) occurred at a median of 22 months (IQR, 16-27). Median changes were -7 cells/mm 3 (IQR, -138 to +117; n = 2992) for CD4+ T-cell count, -60 cells/mm 3 (IQR, -214 to +75; n = 2941; P < .001) for CD8+ T-cell count, and +0.07 (IQR, -0.05 to +0.20; n = 2929; P < .001) for the CD4/CD8 ratio. Baseline CD4/CD8 <1.0 was independently associated with greater ratio increase (adjusted beta, +0.060; 95% CI, +.030 to +.090; P < .001). Longer pre-switch suppression and any post-switch HIV-1 RNA ≥50 copies/mL were associated with smaller ratio increases. Adjudicated virological failure occurred in 28/3349 (0.8%). Findings persisted among participants with all recorded post-switch HIV-1 RNA values <50 copies/mL and after excluding protocol-defined virological failure.

CONCLUSIONS

During effective CAB+RPV LA maintenance, CD4+ T-cell counts showed no meaningful change, while a modest decline in CD8+ T-cell counts was accompanied by a small CD4/CD8 ratio increase. These descriptive changes are compatible with continued immune evolution during sustained suppression and do not establish a CAB+RPV-specific effect or justify additional routine T-cell-subset monitoring.

MeSH

Cells, Rilpivirine, Cell Count