Real-World Use of Long-Acting Cabotegravir for PrEP

Real-world data presented at the 2024 IDWeek annual meeting in Los Angeles highlighted the effectiveness of long-acting (LA) cabotegravir (Apretude) for HIV prevention. Over the first 2 years of use in the U.S., cabotegravir as pre-exposure prophylaxis (PrEP) was associated with high adherence, persistence, and safety in at-risk adults and adolescents.

In this MedPage Today video, Moti Ramgopal, MD, of the Midway Immunology & Research Center in Fort Pierce, Florida, and of Florida State University Medical School, discusses the findings.

Following is a transcript of his remarks:

Cabotegravir long-acting for PrEP was approved by the FDA in 2021 and has demonstrated superiority versus oral PrEP in two large phase III clinical trials. It’s indicated for use in at-risk adults and adolescents weighing at least 35 kg. It’s given as two initiation injections, administered 1 month apart, with continuation injections every 2 months later.

So what were our study objectives? We wanted to evaluate utilization of cabotegravir LA for PrEP for the first 5 years of availability in the U.S. And to describe adherence, resistance, effectiveness, and safety of cabotegravir LA for PrEP in the real-world setting. We obtained data from [the Trio Health HIV Network] research database, which was electronic medical record data from 12 geographically distributed health clinics in the U.S. We looked at persistence, adherence, effectiveness, and safety.

For persistence, we defined this as those remaining in cabotegravir LA for PrEP at time of analysis. And discontinuation was defined as two injection cycles — that’s greater than 127 consecutive days in which no injections were administered without evidence of oral PrEP. For adherence we looked at on-time injections administered plus or minus 7 days from the target injection date, remembering that for initiation injection the target injection was day 30 — so there was 7 days before or after, it was 23 to 37 days. And for continuation injections, at 60 days, was between 53 and 67 days.

For effectiveness we looked at observed HIV seroconversion, by which we looked at detectable RNA positive and a reactive HIV antigen antibody test.

We also looked at safety in which we looked at hypersensitivity reactions (HSR) and drug-induced liver injury (DILI). HSR were identified through ICD-10 codes and adjudicated by the independent adjudication committee through review of clinical notes. DILIs were identified based on elevated ALT [alanine transaminase], ALP [alkaline phosphatase], and bilirubin laboratory results.

We started with roughly over 13,000 individuals with PrEP prescriptions since December 2021, we identified 800 individuals with [cabotegravir] LA for PrEP prescriptions at clinics with injection data. We then subsequently identified 526 individuals with at least one injection of [cabotegravir] LA for PrEP, of which 474 individuals had at least two or more injections for [cabotegravir] LA for which we were able to look at adherence and persistence calculations.

There were no seroconversions observed through year 2 in this diverse population. High persistence and high adherence were observed in this population. HIV testing practices were not aligned with CDC guidelines and no drug-induced liver injury or hypersensitivity reaction events were identified through year 2.