HIV患者が毎日の服薬を中止できる可能性を示す新治療法 (New HIV Treatment Could Enable People to Safely Stop Daily Medication)

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2026-05-27 インペリアル・カレッジ・ロンドン(ICL)

インペリアル・カレッジ・ロンドンが主導した臨床試験「RIO試験」において、HIV感染者が毎日の抗レトロウイルス療法(ART)を安全に中断できる可能性を示す新たな免疫療法が報告された。研究では、広域中和抗体(bNAbs)である「3BNC117-LS」と「10-1074-LS」を組み合わせて投与し、HIVを免疫学的に抑制する効果を検証した。英国とデンマークの68人を対象とした無作為化プラセボ対照試験の結果、抗体治療を受けた患者の75%がART中止後20週間以上ウイルス増殖を抑制できたほか、約半数が1年間、約4分の1が最大2年間にわたり薬剤なしでウイルス量を制御できた。従来のARTは極めて有効だが生涯継続が必要であり、患者負担や医療費の増加が課題である。本研究は、bNAbsがHIVを直接中和するだけでなく、患者自身の免疫応答を強化する可能性を示した点で重要であり、将来的な「ART不要の長期寛解」やHIV機能的治癒に向けた大きな前進と評価されている。ただし恒久的な治癒を示す段階ではなく、効果の持続性や適応患者の特定に向けたさらなる研究が必要である。

HIV患者が毎日の服薬を中止できる可能性を示す新治療法 (New HIV Treatment Could Enable People to Safely Stop Daily Medication)
HIV-1 Virus Particles Replicating Colorized transmission electron micrograph of numerous HIV-1 virus particles (blue) replicating from a segment of a chronically infected H9 T cell (red). Source: National Institute of Allergy and Infectious Diseases

<関連情報>

長時間作用型広域中和抗体3BNC117-LSおよび10-1074-LSの投与と分析的治療中断後のHIV再増殖までの時間(RIO試験):二重盲検無作為化プラセボ対照試験 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

Ming J Lee, PhD ∙ Louise-Rae Cherrill, MSc ∙ DPhil Panagiota Zacharopoulou ∙ Simon Collins ∙ Marcilio Fumagalli, PhD ∙ Emanuela Falaschetti, MSc ∙ et al.
The Lancet HIV  Published: May 27, 2026
DOI:https://doi.org/10.1016/S2352-3018(26)00059-7

Summary

Background

HIV-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.

Methods

RIO 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 100 000 copies per mL. All randomly assigned participants were included in the analyses. This study is registered with ClinicalTrials.gov, NCT04319367.

Findings

68 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 commonly reported treatment-related or procedure-related adverse events were fatigue, lethargy, or somnolence: 11 in arm A and nine in arm B. There were two severe adverse events (anal abscesses) possibly related to the study protocol, both in the placebo arm.

Interpretation

Long-acting bNAbs can sustain extended ART-free viral control in people treated during early-stage HIV and represent a promising step towards achieving ART-free HIV remission.

Funding

Gates Foundation.

医療・健康
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