Direct Initiation of Long-Acting Cabotegravir Plus Rilpivirine in People with HIV and Suboptimal Virologic Suppression: A Randomized Trial
In brief
Injectable cabotegravir-rilpivirine suppresses virus in 88% versus 55% on oral therapy
In a randomized trial of 45 ART-experienced adults with HIV RNA at least 200 copies/mL, starting long-acting cabotegravir plus rilpivirine led to viral suppression (<200 copies) in 88% of participants at 24 weeks, compared with 55% who stayed on oral regimens. The benefit persisted to week 52, suggesting injectables can work for patients struggling with adherence, though the study was small and excluded resistance.
- Journal
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Q1)
- Published
- 1 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Nan-Yu Chen, Cheng-Pin Chen, Yi-Chun Lin, Shu-Hsing Cheng, Shien-Shian Huang, Jun-Yuan Zheng, et al.
- PMID
- 42678348
- DOI
- 10.1093/cid/ciag504
Why clinicians should know about it
- Picked for Microbiology (medical) (top studies of the week, 6 September 2026): HIV long‑acting therapy trial, unrelated to microbiology
Abstract
BACKGROUND: Long-acting injectable cabotegravir plus rilpivirine (LA CAB+RPV) is approved for virally suppressed people with human immunodeficiency virus (HIV), but evidence for its use in those with persistent viremia and adherence challenges remains limited. METHODS: We conducted a multicenter, open-label, randomized study involving oral antiretroviral therapy (ART)-experienced people with HIV who had been diagnosed with HIV for at least 12 months and a most recent HIV-1 RNA level of at least 200 copies per milliliter. Participants with resistance-associated mutations to CAB or RPV were excluded. Eligible participants were randomly assigned in a 1:1 ratio to receive immediate LA CAB+RPV or to continue standard oral therapy until Week 24 (delayed switch group). The primary endpoint was the proportion of participants with an HIV-1 RNA level of less than 200 copies per milliliter at Week 24. RESULTS: Of 61 randomized participants, 45 met eligibility criteria and were included in the analysis; 91% were male, and the median baseline HIV-1 RNA was 35,000 copies/mL. At Week 24, viral suppression was achieved in 88.0% (22/25) in the immediate LA group versus 55.0% (11/20) in the delayed switch group (relative risk for failure to achieve viral suppression, 0.27; 95% CI, 0.08-0.86; p = 0.026). The effect of LA CAB+RPV was sustained through Week 52. CONCLUSIONS: Among people with HIV and viremia associated with adherence challenges, immediate initiation of LA CAB+RPV resulted in higher rates of viral suppression than continued oral ART, supporting its use beyond populations with stable suppression.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.