@article{Lee:2026:10.1016/s2352-3018(26)00059-7,
author = {Lee, MJ and Cherrill, L-R and Zacharopoulou, P and Collins, S and Fumagalli, M and Falaschetti, E and Altaf, M and Tipoe, T and Godakandaarachi, P and Fox, J and Uriel, A and Clarke, A and Loes, SK-D and Pett, S and Boffito, M and Whitlock, G and Søgaard, OS and Ring, K and Mangawa, I and Gohil, J and Elliott, T and Nielsen, H and Gunst, JD and Orkin, C and Sutherland, R and Hamzah, L and Cicconi, P and Taylor, GP and Ujetz, J and Jahan, I and Brown, H and Robinson, N and Fletcher, S and Box, H and Seaton, KE and Tomaras, GD and Ackerman, ME and Weiner, JA and Kaczynska, A and Bittar, C and Horowitz, J and Nussenzweig, MC and Caskey, M and Frater, J and Fidler, S},
doi = {10.1016/s2352-3018(26)00059-7},
journal = {The Lancet HIV},
title = {Time to HIV rebound after infusion of long-acting broadly neutralising antibodies 3BNC117-LS and 10-1074-LS and analytical treatment interruption (the RIO trial): a double-blind, randomised, placebo-controlled trial},
url = {http://dx.doi.org/10.1016/s2352-3018(26)00059-7},
year = {2026}
}

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TY  - JOUR
AB  - BackgroundHIV-specific broadly neutralising antibodies (bNAbs) can maintain viral control after interrupting antiretroviral therapy (ART). We investigated the duration and efficacy of Fc-engineered long-acting bNAbs (LS-bNAbs) in maintaining ART-free HIV control compared with placebo.MethodsRIO is a double-blind, randomised, placebo-controlled trial. Eligibile participants were adults age 18–60 years, initiated on ART in early-stage HIV infection, virally suppressed on ART, and had no evidence of viral insensitivity to 10-1074. Participants were randomly assigned (1:1) to receive two LS-bNAbs (3BNC117-LS and 10-1074-LS) in arm A or saline placebo in arm B; participants and study staff were masked to assignment. Eligible participants interrupted ART after receiving blinded intravenous infusions of either bNAbs or placebo. A second optional infusion was offered after 20 weeks for participants who remained virally suppressed without ART. The primary outcome was time to viral rebound 20 weeks after ART interruption, defined as either the first of six consecutive plasma HIV RNA measurements greater than 1000 copies per mL, or two measurements greater than 100000 copies per mL. All randomly assigned participants were included in the analyses. This study is registered with ClinicalTrials.gov, NCT04319367.Findings68 participants were randomly assigned, 34 to each arm. By week 20, viral rebound had occurred in eight participants in arm A and 30 in arm B; 75% (95% CI 61–92) of participants in arm A did not have viral rebound, compared with 11% (4–29) of participants in arm B. Participants in arm A were 91% less likely to rebound than were those in arm B (hazard ratio 0·09; 95% CI 0·04–0·21, p<0·0001). There were 326 adverse events in arm A and 260 in arm B, including 19 treatment-related or procedure-related adverse events in arm A and 41 in arm B. Of nine serious adverse events, none were treatment-related. The most com
AU  - Lee,MJ
AU  - Cherrill,L-R
AU  - Zacharopoulou,P
AU  - Collins,S
AU  - Fumagalli,M
AU  - Falaschetti,E
AU  - Altaf,M
AU  - Tipoe,T
AU  - Godakandaarachi,P
AU  - Fox,J
AU  - Uriel,A
AU  - Clarke,A
AU  - Loes,SK-D
AU  - Pett,S
AU  - Boffito,M
AU  - Whitlock,G
AU  - Søgaard,OS
AU  - Ring,K
AU  - Mangawa,I
AU  - Gohil,J
AU  - Elliott,T
AU  - Nielsen,H
AU  - Gunst,JD
AU  - Orkin,C
AU  - Sutherland,R
AU  - Hamzah,L
AU  - Cicconi,P
AU  - Taylor,GP
AU  - Ujetz,J
AU  - Jahan,I
AU  - Brown,H
AU  - Robinson,N
AU  - Fletcher,S
AU  - Box,H
AU  - Seaton,KE
AU  - Tomaras,GD
AU  - Ackerman,ME
AU  - Weiner,JA
AU  - Kaczynska,A
AU  - Bittar,C
AU  - Horowitz,J
AU  - Nussenzweig,MC
AU  - Caskey,M
AU  - Frater,J
AU  - Fidler,S
DO  - 10.1016/s2352-3018(26)00059-7
PY  - 2026///
SN  - 2352-3018
TI  - Time to HIV rebound after infusion of long-acting broadly neutralising antibodies 3BNC117-LS and 10-1074-LS and analytical treatment interruption (the RIO trial): a double-blind, randomised, placebo-controlled trial
T2  - The Lancet HIV
UR  - http://dx.doi.org/10.1016/s2352-3018(26)00059-7
UR  - https://doi.org/10.1016/s2352-3018(26)00059-7
ER  - 

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