Real-World Study Finds Long-Acting Cabotegravir+Rilpivirine Highly Effective in Persons with HIV with Detectable Viral Loads at Treatment Inititiaton

This article is part of our IDWeek 2023 coverage. You can find all of our news here.

Among antiretroviral therapy (ART)-experienced individuals with HIV who were nonvirologically suppressed at treatment initiation with long-acting cabotegravir + rilpivirine (CAB+RPV), the injections effectively reduced viral load (VL) to less than 50 copies/mL and suppression was maintained through the study end.

The findings from a real-world study of people living with HIV undergoing routine clinical care were presented today during an oral abstract session at IDWeek 2023, being held from October 11-15 in Boston, MA.

The US Food and Drug Administration (FDA) approved CAB+RPV for injection in January of 2021, making it the first complete, long-acting ART regimen for ART-experienced people living with HIV who are virologically suppressed, defined as a VL less than 50 copies/mL.

During a demonstration project at Ward 86, the first dedicated HIV inpatient clinic in the US, in San Francisco, investigators had observed high rates of virologic suppression after initiation of treatment with CAB+RPV among individuals who were virologically nonsuppressed, defined and VL of 30 or more copies/mL.

In the current study, researchers explored real-world utilization and effectiveness of CAB+RPV over the first 2 years after the drug’s FDA approval in the US, looking specifically at individuals with VL of 50 or more copies/mL when they began treatment in the OPERA®Cohort.

Methods, outcomes

Investigators followed all ART-experienced adults in the OPERA Cohort with a VL of 50 or more copies/mL who were administered their first injection between January 21, 2021, and February 28, 2023. They monitored this cohort until March 25, 2023.

The outcomes of interest, defined in the study abstract, were treatment discontinuation (either an ART switch or the occurrence of 2 consecutive missed doses) and confirmed virologic failure (CVF; 2 consecutive VL measurements exceeding 200 copies/mL or 1 VL measurement exceeding 200 copies/mL followed by treatment discontinuation after reaching a VL less than 50 copies/mL) among all participants with VL of 50 or more copies/mL and for a subgroup of participants with a VL of 200 or more copies/mL.

RESULTS

Of the final cohort of 1843 ART-experienced participants living with HIV who had received at least 1 CAB+RPV injection, 229 individuals (12%) had a VL of 50 or more copies/mL at the treatment initiation. At baseline, this subgroup had a median age of 41 years; 31% were women, 57% were Black, and 20% Hispanic. The median among of time since HIV diagnosis in this group at initiation of CAB+RPV treatment was 9 year, according to the study abstract. Investigators reported a median viral load of 2.1 log copies/mL among participants and a median CD4 count of 579 cells/mL . Over a median follow-up 6.1 months, 83% of these individuals remained on CAB+RPV LA therapy at the conclusion of the study. Among the 80% who had at least one assessment of VL during follow-up, 94% achieved VL levels below 200 copies/mL, and 75% achieved VL levels below 50 copies/mL by the study's conclusion. The research team observed CVF in just 7 individuals (4%).

The team reported similar positive findings among the subset of 93 individuals that had a VL of 200 or more copies/mL when they began CAB+RPV treatment: 90% and 74% achieved VL levels below 200 and below 50 copies/mL, respectively.

In this extensive and diverse real-world cohort, which reflects routine clinical care in the US, CAB+RPV injections proved effective in individuals initiating treatment with viral loads of 50 or more copies/mL. The majority of these individuals successfully achieved and maintained virologic suppression, with VL levels consistently below 50 copies/mL. The findings underscore the clinical utility of CAB+RPV for ART-experienced persons living with HIV who are not virologically suppressed as well as those who are, concluded investigators.

Source: Hsu RK, Sension M, Fusco JS, et al. Real-world use of long-acting cabotegravir + rilpivirine in people with HIV with detectable viral loads at initiation: Findings from the OPERA Cohort. Abstract presented at IDWeek 2023; October 11-15, 2023; Boston, MA.