Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study

RCT (n=1045) found that cabotegravir plus rilpivirine long-acting every 8 weeks was non-inferior to dosing every 4 weeks (HIV-1 RNA ≥50 copies per mL; 2% vs 1%) with an adjusted treatment difference of 0·8 (95% CI −0·6–2·2) supporting use of this 2-monthly regimen.

SPS commentary:

According to a commentary, this study provides reassurance that 8-weekly dosing of long-acting cabotegravir and rilpivirine will maintain virological suppression in those fitting the study criteria, and is therefore ideal for regular clinic attenders. It cautions however that clinical trials are not the real world—as trial participants are motivated and have the benefit of support from clinical trial staff leading to optimal results. It discusses who is most likely to benefit from long-acting injectable antiretrovitral therapy (ART), such as individuals with poor gastrointestinal absorption, swallowing problems, or other comorbidities, though at this time they remain untested. It adds that long-acting injectable ART also benefits those who want different treatment options to minimise inadvertent disclosure of HIV status and facilitate ART adherence when travelling. It notes that the potential benefit for individuals with suboptimal adherence is yet to be shown—people with HIV having adherence difficulties were excluded from both ATLAS and ATLAS-2M studies, and the ramifications of low adherence to injectables and resulting prolonged periods of low ART concentration ideal for the development of HIV drug resistance and treatment failure are unknown. T concludes that despite the leap forward in treatment that injectable therapy represents for people with HIV, key questions remain to be answered to make this a safe and effective treatment option for all.

Source:

The Lancet

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