1028. Real-World Use of Long-Acting Cabotegravir + Rilpivirine in People with HIV with Detectable Viral Loads at Initiation: Findings from the OPERA® Cohort
Authors: Hsu Ricky K , Sension Michael , Fusco Jennifer S , Brunet Laurence , Cochran Quateka , Sridhar Gayathri , Vannappagari Vani , van Wyk Jean A , Wohlfeiler Michael B , Fusco Gregory P 
Published: November 2023

Abstract

Background
Cabotegravir + rilpivirine (CAB+RPV) injections, the first complete long-acting (LA) antiretroviral therapy (ART) regimen, was approved by the FDA in January 2021 for ART-experienced people with HIV (PWH) who are virologically suppressed (VL &lt; 50 copies/mL). Among individuals virologically non-suppressed (VL ≥ 30 copies/mL) at initiation, high rates of virologic suppression were observed in the demonstration project at Ward 86 for CAB+RPV LA. We observed CAB+RPV LA real-world utilization and effectiveness over the first 2 years of availability in the United States (US) in individuals with VL ≥ 50 copies/mL at initiation in the OPERA® Cohort.

Methods
All ART-experienced adults with VL ≥ 50 copies/mL at initiation who received their first CAB+RPV LA injection between 21Jan2021 and 28Feb2023 were followed until 25Mar2023. Discontinuation (ART switch or 2 consecutive missed doses) and confirmed virologic failure (CVF; 2 consecutive VLs ≥ 200 copies/mL or 1 VL ≥ 200 copies/mL + discontinuation after a VL &lt; 50 copies/mL) were described, for all individuals with VL ≥ 50 copies/mL and for the subset with VL ≥ 200 copies/mL.

Results
Of 1843 ART-experienced PWH with ≥ 1 CAB+RPV injections, 229 (12%) had a VL ≥ 50 copies/mL at initiation. At baseline, they were a median of 41 (interquartile range: 32, 52) years of age, 31% female, 57% Black and 20% Hispanic. Injections started a median of 9 (4, 17) years after HIV diagnosis with a median viral load of 2.1 (1.8, 3.8) log copies/mL and median CD4 count of 579 (350, 759) cells/μL (Table 1). Over a median of 6.1 (3.5, 10.1) months of follow-up, 83% were still on CAB+RPV LA at study end. Among the 80% with ≥ 1 VL over follow-up, 94% had a VL &lt; 200 copies/mL and 75% had a VL &lt; 50 copies/mL at study end. CVF was observed in 7 (4%) individuals (Table 2). Similarly for the subset of 93 individuals with a VL ≥ 200 copies/mL at initiation, 90% and 74% had a VL &lt; 200 or &lt; 50 copies/mL at study end, respectively, when follow-up VLs were available (Table 2).

Conclusion
In a large, diverse cohort of real-world, routine clinical care in the US, CAB+RPV LA injections were observed in individuals with viral loads ≥ 50 copies/mL at initiation. Most of these individuals were able to suppress to VL &lt; 50 copies/mL and maintain suppression through study end.

Disclosures
Ricky K. Hsu, MD, Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support|Gilead Sciences: Honoraria|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Janssen: Honoraria|Merck: Advisor/Consultant|Merck: Honoraria|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Honoraria Michael Sension, MD, Gilead: Advisor/Consultant|Gilead: Honoraria|Viiv: Advisor/Consultant|Viiv: Grant/Research Support|Viiv: Honoraria Jennifer S. Fusco, BS, Epividian, Inc.: Salary|Epividian, Inc.: Ownership Interest|Epividian, Inc.: Stocks/Bonds Laurence Brunet, PhD, Epividian, Inc.: Salary|Epividian, Inc.: Stocks/Bonds Gayathri Sridhar, MBBS, MPH, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Full Time Employee Vani Vannappagari, MBBS, MPH, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employee Jean A. van Wyk, MBChB, MFPM, ViiV Healthcare Ltd: Stocks/Bonds Michael B. Wohlfeiler, JD, MD, AAHIVS, ViiV Healthcare: Serves as a PI on clinical trials, but does not receive personal compensation for this work (it goes directly to AIDS Healthcare Foundation) Gregory P. Fusco, MD, MPH, Epividian, Inc.: Board Member|Epividian, Inc.: Ownership Interest|Epividian, Inc.: Stocks/Bonds