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TOPLINE:

Long-acting injectable HIV treatment led to rectal shedding in nearly 15% of patients with HIV, independent of the oral lead-in phase. A high pretreatment viral load was associated with an increased risk for shedding.

METHODOLOGY:

• In this prospective study, researchers analyzed the HIV-1 ribonucleic acid (RNA) and rilpivirine levels in plasma and rectal fluid from people with HIV who switched from oral antiretroviral therapy (ART) to bimonthly intramuscular cabotegravir plus rilpivirine, with or without an oral lead-in phase.
• Patients were divided into two groups: One switched directly to injections, receiving a second dose 1 month after the initial injection, followed by doses every 2 months (n = 58), and the other received a 4-week oral lead-in with daily cabotegravir (30 mg) plus rilpivirine (25 mg) before the first injection (n = 32).
• Overall, 597 plasma and 561 rectal samples (including 536 paired samples) from 90 participants were analyzed. Rectal secretions were collected 4 weeks before the first injection, on the day of the first injection, 1 month after the first injection, and every 2 months until 9 months.
• HIV-1 RNA levels were measured in plasma and rectal swabs, with detection limits of 20 copies/mL for plasma and 50 copies/swab for rectal swabs. Virologic failure was defined as two consecutive viral loads ≥ 200 copies/mL or a single load ≥ 1000 copies/mL in plasma.

TAKEAWAY:

• After 9 months of intramuscular cabotegravir plus rilpivirine therapy, rectal shedding was detected in 14.7% of samples.
• The frequency and quantity of rectal shedding did not differ between the groups, and no significant correlation was found between rectal shedding and plasma HIV-1 RNA levels.
• A high plasma HIV-1 viral load at diagnosis was a significant predictor of rectal shedding (hazard ratio [HR], 3.47; 95% CI, 1.53-7.86).
• Female sex was marginally associated with rectal shedding (HR, 2.49; 95% CI, 0.94-6.62).

IN PRACTICE:

“These results highlight the importance of reservoir-related factors in rectal HIV-1 persistence, suggesting closer monitoring for individuals with high pre-ART viral loads due to potential transmission risk,” the authors wrote.

SOURCE:

This study was led by Mar Masia, Hospital General Universitario de Elche, Elche, Spain. It was published online on March 5, 2025, in The Journal of Infectious Diseases.

LIMITATIONS:

The study’s reproducibility and generalizability may have been limited by the lack of standardized methods for detecting HIV-1 RNA in compartments other than plasma. The absence of a systematic approach to sexually transmitted infection sample collection could have influenced HIV-1 shedding results. The replication competence of detected rectal HIV-1 RNA was not analyzed. Participants were not randomly assigned to the lead-in or non–lead-in groups, and intramuscular ART samples were overrepresented.

DISCLOSURES:

This study was supported by grants from Consorcio Centro de Investigacion Biomédica en Red, Instituto de Salud Carlos III, Ministerio de Ciencia e Innovacion, and Unión Europea — Next Generation EU. None of the authors declared any conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.