557 - Impact of Concomitant Hydroxychloroquine Use on Safety and Efficacy of Remdesivir in Moderate COVID-19 Patients

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Presenting Author(s)

Jose R. Arribas

Head of the Infectious Diseases Unit and Research Director of HIV and Infectious Diseases
Hospital Universitario La Paz
Madrid, Madrid, Spain
Disclosure: Alexa (Advisor or Review Panel member, Speaker's Bureau, Other Financial or Material Support, Personal fees)Gilead Sciences Inc. (Scientific Research Study Investigator, Advisor or Review Panel member, Speaker's Bureau, Other Financial or Material Support, Personal fees)Janssen (Advisor or Review Panel member, Speaker's Bureau, Other Financial or Material Support, Personal fees)Merck (Advisor or Review Panel member, Speaker's Bureau, Other Financial or Material Support, Personal fees)Viiv Healthcare (Advisor or Review Panel member, Speaker's Bureau, Other Financial or Material Support, Personal fees)

Co-Author(s)

AS

Arun J. Sanyal

Practicing Physician
VCU Health Medical Center
Richmond, Virginia
Disclosure: AbbVie (Consultant)Akarna (Shareholder)Amarin (Consultant)Ardelyx (Consultant)Astra Zeneca (Consultant, Research Grant or Support)Boehringer (Consultant)Bristol Myers Squibb (Research Grant or Support)Conatus (Consultant)Cumberland (Research Grant or Support)Durect (Shareholder)Elsevier (Other Financial or Material Support, Royalties)Exhalenz (Shareholder)Fibrogen (Consultant)Genfit (Shareholder)Gilead Sciences Inc. (Consultant, Scientific Research Study Investigator, Research Grant or Support)Haemoshear (Shareholder)Indalo (Shareholder)Intercept (Research Grant or Support)Jannsen (Consultant)Lilly (Consultant)Malinckrodt (Research Grant or Support)Merck (Research Grant or Support)Nimbus (Consultant)Nitto Denko (Consultant)Novartis (Consultant)Pfizer (Consultant)Salix (Consultant)Sanyal Biotechnology (Employee, Shareholder, Other Financial or Material Support, President)Shire (Research Grant or Support)Takeda (Consultant)Tiziana (Shareholder)Tobira (Consultant)UptoDate (Other Financial or Material Support, Royalties)Zafgen (Consultant)
AS

Alex Soriano

Infectious Disease
Hospital Clínic de Barcelona
Barcelona, Catalonia, Spain
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
BC

Bum Sik Chin

Investigator
National Medical Center
Seoul, California
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
SK

Shirin Kalimuddin

Practicing Physician
Singapore General Hospital
Singapore, Singapore
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
SS

Stefan Schreiber

Investigator
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
EE

Emon Elboudwarej

Research Scientist, Bioinformatics
Gilead Sciences Inc.
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
YT

Yuan Tian

Research Scientist, Bioinformatics
Gilead Sciences Inc.
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
RH

Robert H. Hyland

Sr Director, Virology Clinical Research
Gilead Sciences Inc.
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
DS

Devi SenGupta

Sr Director, Clinical Research (MD)
Gilead Sciences Inc.
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
AC

Anand Chokkalingam

Clinical Research
Gilead
Foster City, California
Disclosure: Gilead Sciences (Employee)
AO

Anu Osinusi

Clinical Research
Gilead
Foster City, California
Disclosure: Gilead Sciences (Employee)
Diana M. Brainard

SVP, Therapeutic Area Head, Virology
Gilead Sciences Inc.
Foster City, CA
Disclosure: Gilead Sciences (Employee)
CL

Christoph Lübbert

Investigator
Klinikum St. Georg Klinik für Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie
Leipzig, Hessen, Germany
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
DC

David Chien Boon Lye

Investigator
National Centre for Infectious Diseases, Tan Tock Seng Hospital
Singapore, Singapore
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
JA

Judith A. Aberg

Chief of Division of Infectious Diseases
Icahn School of Medicine at Mount Sinai
New York, New York
Disclosure: Theratechnology (Consultant)
EN

Enrique Navas Elorza

Investigator
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
KT

Karen T. Tashima

Professor of Medicine
Warren Alpert Medical School of Brown University
Providence, RI
Disclosure: Bristol-Myers Squibb (Research Grant or Support)Gilead Sciences Inc. (Grant/Research Support, Scientific Research Study Investigator)GlaxoSmithKline (Research Grant or Support)Merck (Research Grant or Support)Tibotec (Research Grant or Support)Viiv Healthcare (Research Grant or Support)
MM

Mark McPhail

Senior Lecturer and Consultant
King's College Hospital NHS Foundation Trust
London, England, United Kingdom
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)

Background: Remdesivir (RDV) has been shown to shorten recovery time and was well tolerated in patients with severe COVID-19. Hydroxychloroquine (HQN) is an experimental treatment for COVID-19. Effects of coadministration of HQN with RDV have not been studied and are relevant given the long half-life (~22 days) of HQN. We report the impact of concomitant HQN and RDV use on clinical outcomes and safety in patients with moderate COVID-19.

Methods: We enrolled hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation >94% on room air, and radiological evidence of pneumonia. Patients were randomized 1:1:1 to receive 5d or 10d of intravenous RDV once daily plus standard of care (SoC), or SoC only. We compared patients on concomitant HQN (HQN^pos) vs not (HQN^neg). Clinical recovery was evaluated using Cox proportional hazards. Covariate adjustment included age, sex, race, region, symptom duration, oxygen support status and obesity. Recovery and adverse events (AEs) were assessed through death, discharge, or d14.

Results: Of 584 patients, 199 (34%) received HQN (5d RDV: n=57 [30%]; 10d RDV, n=49 [25%]; SoC: n=93 [47%]). Through median follow-up of 13d (range 1-41d), HQN^pos patients on 5d or 10d RDV had a lower recovery rate (adjusted HR [95% CI] 0.78 [0.59, 1.03], p=0.09) with longer median time to recovery (8 vs 6 days) compared to HQN^neg. HQN^pos compared to HQN^neg patients in 5d RDV showed a trend of reduced recovery rate (HR: 0.69 [0.45,1.04], p=0.080); such an effect was not observed in 10d RDV or SoC (Table 1). More HQN^pos than HQN^neg patients had AEs in RDV (5/10d) or SoC arms evaluated separately, and all arms combined. This difference was significant for AEs and SAEs for all arms combined after covariate adjustment (Table 2).Table 1.

Table 2.

Conclusion: In moderate COVID-19 patients, concomitant HQN may delay recovery on RDV and showed no impact on recovery with SoC alone. The AE profile of HQN^pos patients was worse than that observed for HQN^neg patients, regardless of RDV treatment.