Analytical treatment interruption among women with HIV in southern Africa who received VRC01 or placebo in the Antibody Mediated Prevention Study: ATI stakeholder engagement, implementation and early clinical data

作者：Shelly Karuna, Fatima Laher, Sufia Dadabhai, Pei-Chun Yu, Doug Grove, Catherine Orrell, Joseph Makhema, Mina C. Hosseinipour, Carrie‐Anne Mathew, William Brumskine, Nyaradzo Mgodi, P. Andrew, Lúcio Gama, Carissa Karg, Gail Broder, Kagisho Baepanye, Jonathan Lucas, Michele P. Andrasik, Simbarashe Takuva, Manuel Villarán, Azwidihwi Takalani, Randall Tressler, Lydia Soto‐Torres, Amanda S. Woodward Davis, Ames Dhai, Ian Sanne, Myron S. Cohen, Lawrence Corey, Glenda Gray, Allan C. deCamp, Katharine J. Bar · 发表于：Journal of the International AIDS Society · 年份：2025 · DOI：10.1002/jia2.26495 · 被引用次数：3 · 研究领域：HIV/AIDS Research and Interventions、HIV Research and Treatment、HIV/AIDS drug development and treatment

INTRODUCTION: Antiretroviral therapy (ART) prevents and treats, but does not eradicate, HIV. Early ART initiation is associated with post-ART virologic control, particularly among African women, and anti-HIV-1 broadly neutralizing antibodies (bnAbs) may modulate immune responses to HIV. We evaluate whether early ART with or without anti-HIV-1 bnAb VRC01, present at HIV acquisition, is associated with later ART-free control in African women and we assess potential associations with observed control. METHODS: Stakeholder engagement informed analytical treatment interruption (ATI) study design and implementation. Participants who received placebo or VRC01 and acquired HIV in the Antibody Mediated Prevention efficacy trial were assessed for ATI eligibility, including HIV acquisition within 8 weeks of receiving VRC01 or placebo, followed by early ART initiation and ≥1 year of viral suppression. Participation facilitators and barriers were assessed. From May 2021 to February 2024, participants enrolled, stopped ART and received frequent viral load and CD4+ T-cell count monitoring for safety and assessment of meeting ART reinitiation criteria. RESULTS: Thirteen women enrolled from southern Africa. No ATI-related serious adverse events (AEs), HIV transmissions, pregnancies or ≥Grade 2 AEs were observed. Eight sexually transmitted infections were diagnosed in seven women during ATI. Two participants had tenofovir levels consistent with use during ATI; 2/11 (18%) who completed ATI with...