Brief Report: Impact of COVID-19 on Cabotegravir Plus Rilpivirine Long-Acting Dosing Across 6 Ongoing Global Phase IIb and III Clinical Trials.

Autor:	Czarnogorski M; ViiV Healthcare, Research Triangle Park, NC., Benn P; ViiV Healthcare, Brentford, United Kingdom., McCoig C; ViiV Healthcare, Madrid, Spain., Nwafor T; ViiV Healthcare, Research Triangle Park, NC., Griffith S; ViiV Healthcare, Research Triangle Park, NC., Sutton K; ViiV Healthcare, Research Triangle Park, NC., Harrington C; ViiV Healthcare, Research Triangle Park, NC., Saggu P; GlaxoSmithKline, London, United Kingdom; and., Yague I; GlaxoSmithKline, London, United Kingdom; and., Williams W; GlaxoSmithKline, Collegeville, PA., Español CM; GlaxoSmithKline, London, United Kingdom; and., Goodchild J; GlaxoSmithKline, London, United Kingdom; and., Fricker J; GlaxoSmithKline, London, United Kingdom; and., Patel P; ViiV Healthcare, Research Triangle Park, NC., D'Amico R; ViiV Healthcare, Research Triangle Park, NC.
Jazyk:	angličtina
Zdroj:	Journal of acquired immune deficiency syndromes (1999) [J Acquir Immune Defic Syndr] 2022 Oct 01; Vol. 91 (2), pp. 157-161. Date of Electronic Publication: 2022 Jun 04.
DOI:	10.1097/QAI.0000000000003031
Abstrakt:	Background: Cabotegravir + rilpivirine long-acting (LA) is a novel antiretroviral therapy (ART) administered intramuscularly monthly or every 2 months by a health care provider. The COVID-19 pandemic presents a potential challenge to patients' ability to attend scheduled clinic visits for dosing administration. Setting: This analysis evaluated implementation fidelity across 6 phase IIb/III/IIIb cabotegravir + rilpivirine LA clinical trials in 16 countries during the COVID-19 pandemic. Methods: COVID-19-impacted visits were defined as modified dosing visits for which oral therapy was provided to participants unable to attend the clinic or injection visits that were rescheduled. Data from December 1, 2019, to March 1, 2021, were aggregated and analyzed using descriptive statistics. Results: Of 2127 participants in cabotegravir + rilpivirine LA trials, 1997 (94%) had LA dosing visits proceed as planned during the COVID-19 pandemic. Of 130 (6%) participants with injection visits affected by COVID-19, most were from North America (57%) and Europe (26%). Most participants with COVID-19-impacted visits used oral therapy with cabotegravir + rilpivirine (75%) or alternative oral standard-of-care ART (21%) to maintain continuous ART. The most common reasons for missed visits were clinic closure/staffing constraints (48%) and COVID-19-related travel restrictions (23%). Most (98%) participants who used oral ART maintained virologic suppression; 2 participants had viral load between 50 and 100 copies/mL. Conclusion: During the COVID-19 pandemic, most trial participants maintained their LA dosing schedules. Flexibility of the LA dosing regimen, with the ability to switch to oral therapy, facilitated continuous ART provision and implementation fidelity. Competing Interests: M.C., P.B., C.M., T.N., S.G., K.S., C.H., P.P., and R.D. are current or former employees of ViiV Healthcare and may own stock in GlaxoSmithKline. P.S., I.Y., W.W., C.M.E., J.G., and J.F. are employees of and may own stock in GlaxoSmithKline. This study was funded by ViiV Healthcare. The remaining author has no funding or conflicts of interest to disclose. (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)
Databáze:	MEDLINE
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