Real-world use of long-acting injectable cabotegravir and rilpivirine (LAI-CAB+RPV) in non-virally suppressed individuals: a systematic review of baseline characteristics, virological failure outcomes and discontinuations
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Authors
Elias A.
Pasin C.
Smuk M.
Orkin, C.
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Issue Date
2025
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Article
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Purpose: While LAI-CAB+RPV is licensed for virally suppressed individuals (VSI) with HIV-1, it may be of greatest benefit to non-virally suppressed individuals (non-VSI) on oral therapy. We present a summary of real-world cohorts (RWCs) baseline characteristics and outcomes in non-VSI initiating LAI-CAB+RPV. Method(s): We present a systematic literature review from key databases and HIV-related congresses up to March 2025. Data was extracted from RWCs including non-VSI at initiation that reported discrete virological outcomes for >10 non-VSI. We excluded individuals receiving other agents alongside LAI-CAB+RPV. We extracted data on baseline characteristics, discontinuations, and the following VF outcomes: presence/absence of HIV RAMs (major integrase inhibitor[INI]/Non-Nucleoside Reverse Transcriptase Inhibitor[NNRTI] mutations based on Stanford Algorithm), post-VF regimens, and re-suppression. Result(s): We included 14 RWCs describing 561 individuals; 4/14 included non-VSI only, 10/14 were mixed (VSI and non-VSI);all were based in high-income countries (North America[10/14],Europe [3/14], multi-regions [1/14]); 7/14 were multisite cohorts. Baseline characteristics were heterogeneously reported (Figure 1), CD4 counts varied. At least 6 cohorts included some individuals with VL>10,000c/mL at switch (Table 1). VF events occurred in 11/14 cohorts; cohort size ranged from 10-176 individuals at risk (Table 1). VF rate ranged from 0-25%. Genotypic information was provided in 4 cohorts where VF rate ranged between 4-21.4%. RAMs emerged following all VFs with data available(INI 2.6-10.7%;NNRTI 0-21.4%). 4/14 cohorts reported post-VF regimens; PI-based regimens were used in 3 cohorts (1-5 individuals/cohort), an oral INI-based regimen was used in 1 individual, INI/LEN in another. Data on resuppression was reported in 10 individuals; 5 resuppressed. 10 cohorts reported on discontinuation, discontinuation rate ranged between 0-21.4%. Conclusion(s): Cohorts including non-VSI using LAICAB+ RPV in clinical practice have limited data on follow-up duration, and baseline characteristics (CD4 and VL) are heterogeneously presented and scant, limiting generalisability for those with the greatest need. While early evidence is promising, rigorous randomised studies are urgently needed.
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HIV.Med.