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1582. Real-World Use of Long-Acting Cabotegravir + Rilpivirine in the US: Effectiveness in the First Year

BACKGROUND: The first long-acting (LA) antiretroviral therapy (ART) regimen, cabotegravir+rilpivirine (CAB+RPV) injection, was approved by the FDA in January 2021 for ART-experienced, people with HIV (PWH) with undetectable viral load (VL< 50 copies/mL). We assessed clinical effectiveness of CAB+...

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Autores principales: Sension, Michael G, Hsu, Ricky K, Fusco, Jennifer S, Brunet, Laurence, Cochran, Quateka, Uranaka, Christine, Sridhar, Gayathri, Vannappagari, Vani, Zolopa, Andrew, van Wyk, Jean A, McCurdy, Lewis, Fusco, Gregory P, Wohlfeiler, Michael B
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9752331/
http://dx.doi.org/10.1093/ofid/ofac492.105
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author Sension, Michael G
Hsu, Ricky K
Fusco, Jennifer S
Brunet, Laurence
Cochran, Quateka
Uranaka, Christine
Sridhar, Gayathri
Vannappagari, Vani
Zolopa, Andrew
van Wyk, Jean A
McCurdy, Lewis
Fusco, Gregory P
Wohlfeiler, Michael B
author_facet Sension, Michael G
Hsu, Ricky K
Fusco, Jennifer S
Brunet, Laurence
Cochran, Quateka
Uranaka, Christine
Sridhar, Gayathri
Vannappagari, Vani
Zolopa, Andrew
van Wyk, Jean A
McCurdy, Lewis
Fusco, Gregory P
Wohlfeiler, Michael B
author_sort Sension, Michael G
collection PubMed
description BACKGROUND: The first long-acting (LA) antiretroviral therapy (ART) regimen, cabotegravir+rilpivirine (CAB+RPV) injection, was approved by the FDA in January 2021 for ART-experienced, people with HIV (PWH) with undetectable viral load (VL< 50 copies/mL). We assessed clinical effectiveness of CAB+RPV LA in the first year of use in the United States (US). METHODS: Using electronic health record data from the OPERA® cohort, all ART-experienced adults who received ≥1 CAB+RPV LA prescriptions for the first time between 21Jan2021 and 28Feb2022 were followed until 13Mar2022. Discontinuation was defined as an ART switch or > 2 consecutive missed doses. VL were monitored from first injection until end of follow-up or discontinuation. Confirmed virologic failure was defined as 2 consecutive VLs > 200 copies/mL or 1 VL > 200 copies/mL + discontinuation. Results were stratified by VL at first prescription (i.e., suppressed: < 200 copies/mL; viremic: ≥ 200 copies/mL). RESULTS: Of 994 PWH prescribed CAB+RPV, all were ART-experienced and 85% had undetectable VL (< 50 copies/mL), 90% were suppressed (< 200 copies/mL), and the remainder had VL ≥200/mL (6%) or missing baseline VL (4%). Of those prescribed, 344 (38%) received CAB+RPV LA injections over a median 53 (IQR: 35, 79) days; 14% were women, 36% were Black, 29% were Hispanic, 25% had a BMI of ≥30, and the median age was 40 (IQR: 32, 53) years (Table 1). At the end of observation, 62% had not yet received CAB+RPV injections as they were in the process of approval, were on oral lead-in, or had been denied. At study end, 310 (90%) of the 344 remained on CAB+RPV LA with median follow-up of 3.4 (2.2, 6.1) months. Among those with VLs after first injection, the last VL was < 200 copies/mL in 99% and < 50 copies/mL in 94% (Table 2); all follow-up VLs were < 200 copies/mL in 97%, and < 50 copies/mL in 88%. Thirty viremic PWH received CAB+RPV LA injections (Table) with a median VL at first prescription of 4.2 (IQR: 3.2, 4.9) log copies/mL. Five or fewer PWH experienced confirmed virologic failure in each of the suppressed and viremic groups. [Figure: see text] [Figure: see text] CONCLUSION: In this real-world cohort of PWH who received CAB+RPV LA injections in the US, observations from the first year suggest that this regimen is effective among virologically suppressed individuals. DISCLOSURES: Michael G. Sension, MD, Gilead: Advisor/Consultant|Gilead: Honoraria|Viiv: Advisor/Consultant|Viiv: Grant/Research Support|Viiv: Honoraria Ricky K. Hsu, MD, Gilead: Honoraria|Merck: Honoraria|ViiV: Advisor/Consultant|ViiV: Grant/Research Support|ViiV: Honoraria Jennifer S. Fusco, BS, AIDS Healthcare Foundation: Client of my employer|EMD Serono: Client of my employer|Gilead Sciences: Client of my employer|Janssen: Client of my employer|Merck & Co.: Client of my employer|TheraTechnologies: Client of my employer|ViiV Healthcare: Client of my employer Laurence Brunet, PhD, AIDS Healthcare Foundation: Client of my employer|EMD Serono: Client of my employer|Gilead Sciences: Client of my employer|Janssen: Client of my employer|Merck & Co: Client of my employer|TheraTechnologies: Client of my employer|ViiV Healthcare: Client of my employer Gayathri Sridhar, MBBS, MPH, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employment Vani Vannappagari, MBBS, MPH, PhD, ViiV Healthcare: I am full time employee of ViiV Healthcare and receive GlaxoSmithKline stock as part of my compensation package|ViiV Healthcare: Stocks/Bonds Andrew Zolopa, MD, ViiV Healthcare: full time employee|ViiV Healthcare: Stocks/Bonds Jean A. van Wyk, MB,ChB; MFPM, ViiV Healthcare Limited: I am an employee of ViiV Healthcare|ViiV Healthcare Limited: Stocks/Bonds Gregory P. Fusco, MD, MPH, AIDS Healthcare Foundation: Client of employer|EMD: Grant/Research Support|Gilead Sciences: Client of employer|Janssen: Client of employer|Merck & Co.: Client of employer|Theratechnologies: Client of employer|ViiV Healthcare: Client of employer.
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spelling pubmed-97523312022-12-16 1582. Real-World Use of Long-Acting Cabotegravir + Rilpivirine in the US: Effectiveness in the First Year Sension, Michael G Hsu, Ricky K Fusco, Jennifer S Brunet, Laurence Cochran, Quateka Uranaka, Christine Sridhar, Gayathri Vannappagari, Vani Zolopa, Andrew van Wyk, Jean A McCurdy, Lewis Fusco, Gregory P Wohlfeiler, Michael B Open Forum Infect Dis Abstracts BACKGROUND: The first long-acting (LA) antiretroviral therapy (ART) regimen, cabotegravir+rilpivirine (CAB+RPV) injection, was approved by the FDA in January 2021 for ART-experienced, people with HIV (PWH) with undetectable viral load (VL< 50 copies/mL). We assessed clinical effectiveness of CAB+RPV LA in the first year of use in the United States (US). METHODS: Using electronic health record data from the OPERA® cohort, all ART-experienced adults who received ≥1 CAB+RPV LA prescriptions for the first time between 21Jan2021 and 28Feb2022 were followed until 13Mar2022. Discontinuation was defined as an ART switch or > 2 consecutive missed doses. VL were monitored from first injection until end of follow-up or discontinuation. Confirmed virologic failure was defined as 2 consecutive VLs > 200 copies/mL or 1 VL > 200 copies/mL + discontinuation. Results were stratified by VL at first prescription (i.e., suppressed: < 200 copies/mL; viremic: ≥ 200 copies/mL). RESULTS: Of 994 PWH prescribed CAB+RPV, all were ART-experienced and 85% had undetectable VL (< 50 copies/mL), 90% were suppressed (< 200 copies/mL), and the remainder had VL ≥200/mL (6%) or missing baseline VL (4%). Of those prescribed, 344 (38%) received CAB+RPV LA injections over a median 53 (IQR: 35, 79) days; 14% were women, 36% were Black, 29% were Hispanic, 25% had a BMI of ≥30, and the median age was 40 (IQR: 32, 53) years (Table 1). At the end of observation, 62% had not yet received CAB+RPV injections as they were in the process of approval, were on oral lead-in, or had been denied. At study end, 310 (90%) of the 344 remained on CAB+RPV LA with median follow-up of 3.4 (2.2, 6.1) months. Among those with VLs after first injection, the last VL was < 200 copies/mL in 99% and < 50 copies/mL in 94% (Table 2); all follow-up VLs were < 200 copies/mL in 97%, and < 50 copies/mL in 88%. Thirty viremic PWH received CAB+RPV LA injections (Table) with a median VL at first prescription of 4.2 (IQR: 3.2, 4.9) log copies/mL. Five or fewer PWH experienced confirmed virologic failure in each of the suppressed and viremic groups. [Figure: see text] [Figure: see text] CONCLUSION: In this real-world cohort of PWH who received CAB+RPV LA injections in the US, observations from the first year suggest that this regimen is effective among virologically suppressed individuals. DISCLOSURES: Michael G. Sension, MD, Gilead: Advisor/Consultant|Gilead: Honoraria|Viiv: Advisor/Consultant|Viiv: Grant/Research Support|Viiv: Honoraria Ricky K. Hsu, MD, Gilead: Honoraria|Merck: Honoraria|ViiV: Advisor/Consultant|ViiV: Grant/Research Support|ViiV: Honoraria Jennifer S. Fusco, BS, AIDS Healthcare Foundation: Client of my employer|EMD Serono: Client of my employer|Gilead Sciences: Client of my employer|Janssen: Client of my employer|Merck & Co.: Client of my employer|TheraTechnologies: Client of my employer|ViiV Healthcare: Client of my employer Laurence Brunet, PhD, AIDS Healthcare Foundation: Client of my employer|EMD Serono: Client of my employer|Gilead Sciences: Client of my employer|Janssen: Client of my employer|Merck & Co: Client of my employer|TheraTechnologies: Client of my employer|ViiV Healthcare: Client of my employer Gayathri Sridhar, MBBS, MPH, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employment Vani Vannappagari, MBBS, MPH, PhD, ViiV Healthcare: I am full time employee of ViiV Healthcare and receive GlaxoSmithKline stock as part of my compensation package|ViiV Healthcare: Stocks/Bonds Andrew Zolopa, MD, ViiV Healthcare: full time employee|ViiV Healthcare: Stocks/Bonds Jean A. van Wyk, MB,ChB; MFPM, ViiV Healthcare Limited: I am an employee of ViiV Healthcare|ViiV Healthcare Limited: Stocks/Bonds Gregory P. Fusco, MD, MPH, AIDS Healthcare Foundation: Client of employer|EMD: Grant/Research Support|Gilead Sciences: Client of employer|Janssen: Client of employer|Merck & Co.: Client of employer|Theratechnologies: Client of employer|ViiV Healthcare: Client of employer. Oxford University Press 2022-12-15 /pmc/articles/PMC9752331/ http://dx.doi.org/10.1093/ofid/ofac492.105 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Abstracts
Sension, Michael G
Hsu, Ricky K
Fusco, Jennifer S
Brunet, Laurence
Cochran, Quateka
Uranaka, Christine
Sridhar, Gayathri
Vannappagari, Vani
Zolopa, Andrew
van Wyk, Jean A
McCurdy, Lewis
Fusco, Gregory P
Wohlfeiler, Michael B
1582. Real-World Use of Long-Acting Cabotegravir + Rilpivirine in the US: Effectiveness in the First Year
title 1582. Real-World Use of Long-Acting Cabotegravir + Rilpivirine in the US: Effectiveness in the First Year
title_full 1582. Real-World Use of Long-Acting Cabotegravir + Rilpivirine in the US: Effectiveness in the First Year
title_fullStr 1582. Real-World Use of Long-Acting Cabotegravir + Rilpivirine in the US: Effectiveness in the First Year
title_full_unstemmed 1582. Real-World Use of Long-Acting Cabotegravir + Rilpivirine in the US: Effectiveness in the First Year
title_short 1582. Real-World Use of Long-Acting Cabotegravir + Rilpivirine in the US: Effectiveness in the First Year
title_sort 1582. real-world use of long-acting cabotegravir + rilpivirine in the us: effectiveness in the first year
topic Abstracts
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9752331/
http://dx.doi.org/10.1093/ofid/ofac492.105
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