At CROI 2025, new research from the Trio Health Cohort, a real-world population of patients with HIV, has shown high rates of continued virologic suppression with cabotegravir-rilpivirine (Cabenuva, ViiV Healthcare).
Investigator Paul E. Sax, MD, the clinical director of the Division of Infectious Diseases and the Bruce A. Beal and Robert L. Beal Endowed Chair in Infectious Diseases at Brigham and Women’s Hospital, and a professor of medicine at Harvard Medical School, in Boston, sat down with Pharmacy Practice News to talk about the study results. For more from CROI 2025, check out our meeting coverage page.
Meaghan Lee Callaghan 0:11
So you had some interesting research presented at CROI this year, in San Francisco. Can you talk a little bit about what the main takeaway was of your findings?
Dr. Sax 0:18
Sure, this is as part of a group that is called Trio Health Cohort. And what we do is we look at people in clinical practice in the United States in a wide variety of areas, and then try to capture what is often called real-world data on various factors of HIV care and treatment. And this particular study looked at the outcomes of long-acting injectable cabotegravir-rilpivirine among people starting that treatment with virologic suppression. Thats, of course, how it is FDA approved. And so we conducted this study looking at medical records from people starting this treatment in the Trio Health Cohort from between February 2021 to March of 2024. And predominantly, they were receiving every-two-month treatment, but there was also every-one-month treatment, and we were able to find over 1,000 people who started this treatment. So it was 1,198 people who initiated the treatment, and our primary outcome of interest was proportion of people still on the treatment and successfully virologically suppressed. So you know, in a study like this, of course you’re going to lose some participants because you don’t have complete capture, but we ended up, at the end of the cohort, having over 900 people: 944 who remained on treatment and virologically suppressed. And the good news is that the primary outcome of interest, which is the biggest concern with cabotegravir-rilpivirine, the virologic failure and emergence of resistance was extremely uncommon. So we had virologic failure detected in less than 2% of the 1,198 people with HIV who started treatment. And in that group of people, there was just a small number who had virologic failure (15). There were five people who underwent genotyping. What we determined is that in that group, three of the people—so that’s 0.25% of the total cohort—developed rilpivirine resistance. And here the most important point is that cabotegravir resistance was found in only one individual, and that was for a rate of less than 0.1%. So these results, I just want to emphasize, are quite consistent with how cabotegravir-rilpivirine performed in clinical trials. There is a nonzero risk of virologic failure with resistance, but fortunately, it appears to be very low.
Meaghan Lee Callaghan 2:59
So the findings are impressive. Were you surprised by what you found?
Dr. Sax 3:02
I guess I found the findings consistent with other effectiveness studies of cabotegravir-rilpivirine. The good news is that the resistance emergence was rare. The limitation of the study is important, and that is that studies like this necessarily can only capture the people who continue to receive care through the sites that they’re enrolled in. And so there is a fair number of people in the study who we just couldn’t account for what happened to them. And in that situation, you know, there’s really nothing we can do about it, because this is a sort of retrospective review of care that’s already been received. These are not people prospectively entered into a study. So you know, as a result, with that limitation, you can only say really informed things about the people who remain in the study.
Meaghan Lee Callaghan 3:57
What do you think your findings and the other literature out there mean for providers who are treating patients with HIV?
Dr. Sax 4:07
What I would say the take-home message is, is that the treatment, cabotegravir-rilpivirine long-acting injectable, given either every month or every two months, can be initiated in people with virologic suppression, with a very low risk of treatment-emergent resistance. I do think it should be part of the counseling with anyone considering this treatment that the risk isn’t zero, but it’s quite low. And at least in our study, the occurrence of integrase inhibitor resistance, which is the most feared form of resistance from this treatment, was extremely uncommon.
Transcribed by https://otter.ai
