Key secondary end points of virologic failure and treatment-related failure met predefined stopping criterion
By Elana Gotkine HealthDay Reporter
TUESDAY, March 12, 2024 (HealthDay News) — For people with HIV (PWH) and a history of suboptimal adherence to antiretroviral therapy, long-acting injectable treatment with cabotegravir and rilpivirine (LAI) is superior to oral standard of care (SOC), according to a study presented at the annual Conference on Retroviruses and Opportunistic Infections, held from March 3 to 6 in Denver.
Aadia I. Rana, M.D., from the University of Alabama at Birmingham, and colleagues compared LAI to oral SOC antiretroviral treatment in PWH with a history of suboptimal adherence. A total of 434 participants were enrolled to step 1 where they received conditional cash incentives for viral suppression on SOC of up to 24 weeks; 294 participants were then randomly assigned to monthly LAI versus continuation of SOC for 52 weeks (146 and 148 individuals, respectively).
The researchers found the two arms had similar cumulative probability of adverse events. Three participants receiving LAI had grade â¥3 injection site reactions (ISR), and one discontinued treatment due to ISR. The LAI arm was favored in all efficacy end points. The primary composite end point was the earliest occurrence of virologic failure or treatment discontinuation; for this interim analysis, the primary end point did not meet the predefined stopping criterion, but key secondary end points of virological failure and treatment-related failure met this criterion, indicating superiority of the LAI arm.
“This study shows long-acting technology is safe and effective among the people with HIV who stand to benefit most from its use,” Rana said in a statement. “Offering an effective alternative for people who have struggled with taking daily ART could provide life-changing freedom from the stress of unsuppressed HIV.”
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