Extended trial data show injectable HIV regimen effective when given every 2 months
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Long-acting cabotegravir and rilpivirine dosed every 8 weeks was effective and well tolerated, showing noninferiority to the standard 4-week dosing at 152 weeks, according to extended data from the ATLAS-2M trial.
“This study was designed to evaluate the administration of long-acting ART with Cabenuva (cabotegravir and rilpivirine long acting, or CAB + RPV LA) every 8 weeks compared to administration every 4 weeks,” Edgar T. Overton, MD, associate professor in the department of medicine, division of infectious diseases, at the University of Alabama at Birmingham, told Healio.
“Pharmacokinetic data supported the longer interval in administration and early phase studies also supported administration every 8 weeks,” he said.
Overton said that the study, called ATLAS-2M, was a phase 3 open-label, noninferiority trial to confirm that every 8-week dosing was effective and tolerable. According to the study, virologically suppressed people were randomly assigned to receive CAB+RPV LA either every 8 weeks or every 4 weeks, with assessed endpoints being the proportion of participants with plasma HIV-1 RNA 50 copies/mL or more and less than 50 copies/mL, incidence of confirmed virologic failure (two consecutive measurements of 200 copies/mL or more), safety and tolerability.
In total, 1,045 participants received CAB+RPV LA — 522 for 8 weeks and 523 for 4 weeks. Overall, they found that CAB+RPV LA for 8 weeks was noninferior vs. the 4-week regimen, with 2.7%, or 14 patients, and 1%, or five patients, not being virologically suppressed and having HIV-1 RNA 50 copies/mL or more, respectively.
According to the study, the adjusted treatment difference in proportions was 1.7% (95% CI, 0.1-3.3), which met the prespecified noninferiority threshold of 4%. Additionally, at week 152, 87% of patients maintained HIV-1 RNA less than 50 copies/mL (87% at 8 weeks vs. 86% at 4 weeks).
These results build on previously reported ATLAS-2M data comparing the two dosing regimens at 48-weeks and 96-weeks. In both regimens, data showed that CAB+RPV LA dosed every 8 weeks was a safe and effective therapy for the maintenance of HIV-1 virologic suppression.
“Long-acting ART with CAB + RPV LA dosed 8-weeks or 4-weeks provides durable virologic suppression through 3 years of follow-up with an acceptable safety profile and favorable patient satisfaction and preference profile,” Overton said.
“This long-acting therapy affords an alternative approach to HIV treatment that addresses some of the challenges that patients face with oral therapy, including fear of disclosure, anxiety around adherence, and oral ART serving as a daily reminder of HIV,” he said.
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