Evaluation of the effects of pre-exposure treatment with hydroxychloroquine on the risk of COVID-19 infection and on the efficacy of anti-COVID-19 vaccination during lupus or Gougerot-Sjögren’s disease: Prepcov multicentre trial

Objectives Some patients with SLE or Gougerot-Sjögren’s disease (GSD) receive long-term treatment with hydroxychloroquine (HCQ), sometimes combined with immunosuppressive therapy (IS). This study sought to assess whether long-term HCQ therapy that had been initiated long before the COVID-19 pandemic...

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Main Authors: Patrice Cacoub, David Ribes, Laurent Alric, Dominique Chauveau, Grégory Pugnet, Laurent Sailler, Estibaliz Lazaro, Martin Michaud, Marion Migueres, Mathieu Vautier, Kim Ly, Anne Laure Fauchais, Emilie Berard, Morgane Mourguet, Clara Brusq, Stephanie Faure, Pascal Lebray, Jean François Viallard, Carle Paul, Arnaud Constatin, Adeline Ruysen Wittrand, Marie Irles Depe
Format: Article
Language:English
Published: BMJ Publishing Group 2025-03-01
Series:Lupus Science and Medicine
Online Access:https://lupus.bmj.com/content/12/1/e001435.full
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author Patrice Cacoub
David Ribes
Laurent Alric
Dominique Chauveau
Grégory Pugnet
Laurent Sailler
Estibaliz Lazaro
Martin Michaud
Marion Migueres
Mathieu Vautier
Kim Ly
Anne Laure Fauchais
Emilie Berard
Morgane Mourguet
Clara Brusq
Stephanie Faure
Pascal Lebray
Jean François Viallard
Carle Paul
Arnaud Constatin
Adeline Ruysen Wittrand
Marie Irles Depe
author_facet Patrice Cacoub
David Ribes
Laurent Alric
Dominique Chauveau
Grégory Pugnet
Laurent Sailler
Estibaliz Lazaro
Martin Michaud
Marion Migueres
Mathieu Vautier
Kim Ly
Anne Laure Fauchais
Emilie Berard
Morgane Mourguet
Clara Brusq
Stephanie Faure
Pascal Lebray
Jean François Viallard
Carle Paul
Arnaud Constatin
Adeline Ruysen Wittrand
Marie Irles Depe
collection DOAJ
description Objectives Some patients with SLE or Gougerot-Sjögren’s disease (GSD) receive long-term treatment with hydroxychloroquine (HCQ), sometimes combined with immunosuppressive therapy (IS). This study sought to assess whether long-term HCQ therapy that had been initiated long before the COVID-19 pandemic had a protective or adverse effect on COVID-19 risk, severity of infection or immunity protection.Methods This prospective multicentre study included 547 patients with SLE, GSD, autoimmune hepatitis, primary biliary cholangitis or cured viral hepatitis C divided into four groups according to HCQ (+/−) and IS (+/−) intake prior to the pandemic: HCQ+IS+ (n=112), HCQ+IS− (n=121), HCQ−IS+ (n=115) and HCQ−IS− (n=199). When COVID-19 vaccination was possible, patients were vaccinated as recommended. Vaccination efficacy was prospectively assessed on the basis of the postvaccination antibody titre.Results Compared with HCQ+IS+ patients, HCQ−IS+ patients had a decreased risk of COVID-19 infection (p<0.001). Compared with HCQ+IS+ patients, HCQ−IS− patients had a decreased risk of contracting COVID-19 (p<0.001). Patients in the HCQ−IS+ or HCQ−IS− group had a lower risk of symptomatic or severe infection than HCQ+IS+ patients did (p=0.001 and p<0.001, respectively). Only patients who had two or more exposures (to vaccine and/or infection) had an increased likelihood of COVID-19 immunity after the last dose (p<0.001).Conclusions HCQ treatment that was initiated before the pandemic did not protect against COVID-19 infection. Moreover, non-exposure to HCQ treatment (combined or not with IS) was associated with decreased risk of COVID-19 infection and of developing a symptomatic or severe infection. HCQ and IS do not influence the vaccine response. Only two or more doses of vaccine result in a good vaccine response.Trial registration number NCT04481633.
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spelling doaj-art-cbd8e761d9664a36aca0137fff98da102025-08-20T03:16:22ZengBMJ Publishing GroupLupus Science and Medicine2053-87902025-03-0112110.1136/lupus-2024-001435Evaluation of the effects of pre-exposure treatment with hydroxychloroquine on the risk of COVID-19 infection and on the efficacy of anti-COVID-19 vaccination during lupus or Gougerot-Sjögren’s disease: Prepcov multicentre trial Patrice Cacoub0David RibesLaurent Alric1Dominique Chauveau2Grégory Pugnet3Laurent Sailler4Estibaliz LazaroMartin MichaudMarion Migueres5Mathieu VautierKim LyAnne Laure FauchaisEmilie Berard6Morgane MourguetClara Brusq7Stephanie Faure8Pascal Lebray9Jean François Viallard10Carle PaulArnaud ConstatinAdeline Ruysen WittrandMarie Irles DepeService de Médecine Interne et Immunologie Clinique, Hopital Pitie-Salpetriere, Paris, FranceToulouse III University-Paul Sabatier, Toulouse, FranceKidney Disease Unit, Toulouse III University-Paul Sabatier Faculty of Health, Toulouse, FranceInternal Medicine Department, Toulouse III University-Paul Sabatier Faculty of Health, Toulouse, FrancePurpan Hospital, Toulouse, FranceVirology Unit, CHU Toulouse, Toulouse, FranceService d’Epidémiologie et Santé Publique, Toulouse III University-Paul Sabatier Faculty of Health, Toulouse, FranceUnité de Soutien Méthodologique à la Recherche (USMR), Service d’Epidémiologie Clinique et de Santé Publique, CHU de Toulouse, Toulouse III University-Paul Sabatier, Toulouse, FranceHepatogastroenterology, Montpellier University, Montpellier, FranceHepatology Unit, Hopital Universitaire Pitie-Salpetriere, Paris, FranceInternal Medicine, Bordeaux III University, Bordeaux, FranceObjectives Some patients with SLE or Gougerot-Sjögren’s disease (GSD) receive long-term treatment with hydroxychloroquine (HCQ), sometimes combined with immunosuppressive therapy (IS). This study sought to assess whether long-term HCQ therapy that had been initiated long before the COVID-19 pandemic had a protective or adverse effect on COVID-19 risk, severity of infection or immunity protection.Methods This prospective multicentre study included 547 patients with SLE, GSD, autoimmune hepatitis, primary biliary cholangitis or cured viral hepatitis C divided into four groups according to HCQ (+/−) and IS (+/−) intake prior to the pandemic: HCQ+IS+ (n=112), HCQ+IS− (n=121), HCQ−IS+ (n=115) and HCQ−IS− (n=199). When COVID-19 vaccination was possible, patients were vaccinated as recommended. Vaccination efficacy was prospectively assessed on the basis of the postvaccination antibody titre.Results Compared with HCQ+IS+ patients, HCQ−IS+ patients had a decreased risk of COVID-19 infection (p<0.001). Compared with HCQ+IS+ patients, HCQ−IS− patients had a decreased risk of contracting COVID-19 (p<0.001). Patients in the HCQ−IS+ or HCQ−IS− group had a lower risk of symptomatic or severe infection than HCQ+IS+ patients did (p=0.001 and p<0.001, respectively). Only patients who had two or more exposures (to vaccine and/or infection) had an increased likelihood of COVID-19 immunity after the last dose (p<0.001).Conclusions HCQ treatment that was initiated before the pandemic did not protect against COVID-19 infection. Moreover, non-exposure to HCQ treatment (combined or not with IS) was associated with decreased risk of COVID-19 infection and of developing a symptomatic or severe infection. HCQ and IS do not influence the vaccine response. Only two or more doses of vaccine result in a good vaccine response.Trial registration number NCT04481633.https://lupus.bmj.com/content/12/1/e001435.full
spellingShingle Patrice Cacoub
David Ribes
Laurent Alric
Dominique Chauveau
Grégory Pugnet
Laurent Sailler
Estibaliz Lazaro
Martin Michaud
Marion Migueres
Mathieu Vautier
Kim Ly
Anne Laure Fauchais
Emilie Berard
Morgane Mourguet
Clara Brusq
Stephanie Faure
Pascal Lebray
Jean François Viallard
Carle Paul
Arnaud Constatin
Adeline Ruysen Wittrand
Marie Irles Depe
Evaluation of the effects of pre-exposure treatment with hydroxychloroquine on the risk of COVID-19 infection and on the efficacy of anti-COVID-19 vaccination during lupus or Gougerot-Sjögren’s disease: Prepcov multicentre trial
Lupus Science and Medicine
title Evaluation of the effects of pre-exposure treatment with hydroxychloroquine on the risk of COVID-19 infection and on the efficacy of anti-COVID-19 vaccination during lupus or Gougerot-Sjögren’s disease: Prepcov multicentre trial
title_full Evaluation of the effects of pre-exposure treatment with hydroxychloroquine on the risk of COVID-19 infection and on the efficacy of anti-COVID-19 vaccination during lupus or Gougerot-Sjögren’s disease: Prepcov multicentre trial
title_fullStr Evaluation of the effects of pre-exposure treatment with hydroxychloroquine on the risk of COVID-19 infection and on the efficacy of anti-COVID-19 vaccination during lupus or Gougerot-Sjögren’s disease: Prepcov multicentre trial
title_full_unstemmed Evaluation of the effects of pre-exposure treatment with hydroxychloroquine on the risk of COVID-19 infection and on the efficacy of anti-COVID-19 vaccination during lupus or Gougerot-Sjögren’s disease: Prepcov multicentre trial
title_short Evaluation of the effects of pre-exposure treatment with hydroxychloroquine on the risk of COVID-19 infection and on the efficacy of anti-COVID-19 vaccination during lupus or Gougerot-Sjögren’s disease: Prepcov multicentre trial
title_sort evaluation of the effects of pre exposure treatment with hydroxychloroquine on the risk of covid 19 infection and on the efficacy of anti covid 19 vaccination during lupus or gougerot sjogren s disease prepcov multicentre trial
url https://lupus.bmj.com/content/12/1/e001435.full
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