Previous studies have shown that cabotegravir and rilpivirine (Cabenuva) injections every 4 weeks provided a similar result to oral ART therapy. This regimen has received FDA approval. Will the FDA approve injection every 8 weeks as well? A new international study randomized 1045 adults to either receive the injection every 4 weeks or every 8 weeks has been completed. The end point for the two groups was maintenance of a viral load less than 50 copies over a period of 12 months. The 8-week regimen was found to be “non-inferior” to the 4-week approach, even with a failure rate of 2% in the 8-week subgroup and less than 1 % in the 4-week subgroup.
With this overall significant result, approval of the broader use of the drug for 8 weeks has been submitted to the FDA. This injectable ART approach will provide alternatives in the management of HIV in older adults with HIV. One clear advantage will be the reduction in pill burden, especially for those who are involved in treatments for multiple age-related disorders.
The efficacy and safety profiles of dosing every 8 weeks and dosing every 4 weeks were similar. These results support the use of cabotegravir plus rilpivirine long-acting administered every 2 months as a therapeutic option for people living with HIV.
REFERENCE
Overton, E. T., et al. (2021). “Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomized, multicentre, open-label, phase 3b, non-inferiority study.” Lancet 396(10267): 1994-2005.