Long-acting injectable effective, well tolerated in patients with HIV regardless of race
Long-acting injectable effective, well tolerated in patients with HIV regardless of race
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WASHINGTON — Studies of long-acting cabotegravir plus rilpivirine demonstrated high efficacy, safety and satisfaction in people with HIV regardless of race, according to data presented at IDWeek.
“Long-acting cabotegravir plus rilpivirine (CAB + RPV LA) administered monthly or every 2 months is the first and only complete long-acting injectable maintenance regimen recommended by treatment guidelines for people living with HIV-1 with virological suppression,” Moti Ramgopal, MD, medical director of the Midway Immunology and Research Center, said during a presentation at IDWeek.
“Racial disparities in treatment outcomes are multifactorial and may be influenced by demographic, clinical, socioeconomic and adherence factors. These may be further compounded by the underrepresentation of non-white participants in clinical trials,” Ramgopal said.
In a post hoc analysis summarizing pooled outcomes of participants in the FLAIR and ATLAS-2M global phase 3/3b studies, Ramgopal and colleagues aimed to assess these outcomes by patient race through week 96.
According to the study, data from participants randomized to receive CAB + RPV LA every 4 weeks or 8 weeks in the FLAIR and ATLAS-2M studies were pooled and stratified by race — specifically, Black or African American, white, Asian and other race. Study endpoints were the proportion of participants with HIV-1 RNA 50 or more copies/mL and HIV-1 RNA less than 50 copies/mL at week 96.
In total, 937 participants received CAB + RPV LA — 76% of whom were white, 16% Black or African American, 4% Asian and 4% classified as other race. Study data showed that at week 96, 2% and 3% of Black and white participants, respectively, experienced virologic nonresponse (HIV-1 RNA 50 or more copies/mL). Rates of viral suppression varied across races, with 92%, 87%, 83% and 94% of Black, white, Asian and participants classified as “other race” reporting HIV-1 RNA less than 50 copies/mL.
Additional data on adverse events showed that drug-related grade 3 or higher adverse events occurred in 2% of participants, ranging from 0% to 3% across races, excluding injection site reactions (ISRs). Drug-related serious adverse events occurred in five participants, whereas overall, 99% of ISR events were grade 1 or 2; 2% (n = 20) of participants withdrew for injection-related reasons.
“CAB + RVP LA dosed monthly and every 2 months demonstrated comparable efficacy and safety outcomes across races through week 96 and may be an effective treatment option for the maintenance of virologic suppression in people living with HIV-1,” Ramgopal said.
[Editor’s note: The headline on this story was changed to reflect that the study was about HIV treatment and not PrEP.]
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Patel P, et al. Abstract 1586. Presented at: IDWeek; Oct. 192022. Washington (hybrid meeting).
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