Long‐term clinical, virological and immunological outcomes following planned treatment interruption in HIV‐infected children

• Published in: HIV medicine 2021-03, Vol.22 (3), p.172-184
• Main Authors: Freguja, R, Bamford, A, Zanchetta, M, Del Bianco, P, Giaquinto, C, Harper, L, Dalzini, A, Cressey, TR, Compagnucci, A, Saidi, Y, Riault, Y, Ford, D, Gibb, D, Klein, N, De Rossi, A
• Format: Article
• Language: English
• Subjects: Antiretroviral agents; Antiretroviral therapy; ARV; CD4 antigen; CD4 Lymphocyte Count; CD4-Positive T-Lymphocytes; CD8 antigen; CD8-Positive T-Lymphocytes; Child; Children; HIV; HIV Infections - drug therapy; Human immunodeficiency virus; Humans; Immunology; Memory cells; Original Research; Randomized Controlled Trials as Topic; Regression analysis; Ribonucleic acid; RNA; treatment interruption; Treatment Outcome; Tuberculosis; Viral Load; virology
• ISSN: 1464-2662; 1468-1293
• DOI: 10.1111/hiv.12986

Objectives Planned treatment interruption (PTI) of antiretroviral therapy (ART) in adults is associated with adverse outcomes. The PENTA 11 trial randomized HIV‐infected children to continuous ART (CT) vs. CD4‐driven PTIs. We report 5 years’ follow‐up after the end of main trial. Methods Post‐trial, all children resumed ART. Clinical, immunological, virological and treatment data were collected annually. A sub‐study investigated more detailed immunophenotype. CT and PTI arms were compared using intention‐to‐treat. Laboratory parameters were compared using linear regression, adjusting for baseline values; mixed models were used to include all data over time. Results In all, 101 children (51 CT, 50 PTI) contributed a median of 7.6 years, including 5.1 years of post‐trial follow‐up. Post‐trial, there were no deaths, one pulmonary tuberculosis and no other CDC stage B/C events. At 5 years post‐trial, 90% of children in the CT vs. 82% in the PTI arm had HIV RNA