Journal Article

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

Depe, Marie Irles, Ly, Kim, Mourguet, Morgane, Faure, Stephanie, Sailler, Laurent, Wittrand, Adeline Ruysen, Migueres, Marion, Viallard, Jean François, Paul, Carle, Bérard, Emilie, Alric, Laurent, Pugnet, Grégory, Chauveau, Dominique, Michaud, Martin, Cacoub, Patrice, Constatin, Arnaud, Ribes, David, Brusq, Clara, Fauchais, Anne Laure, Lazaro, Estibaliz, Lebray, Pascal, Vautier, Mathieu

2025

Overview

ObjectivesSome 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.MethodsThis 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.ResultsCompared 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).ConclusionsHCQ 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 numberNCT04481633.

• Publisher: Lupus Foundation of America,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Adult / Aged / Autoimmune diseases / Co-Morbidities / COVID-19 / COVID-19 - epidemiology / COVID-19 - immunology / COVID-19 - prevention & control / COVID-19 vaccines / COVID-19 Vaccines - administration & dosage / COVID-19 Vaccines - immunology / Disease transmission / Enzymes / Female / Hepatitis / Humans / Hydroxychloroquine - administration & dosage / Hydroxychloroquine - therapeutic use / Immunosuppressive Agents - administration & dosage / Immunosuppressive Agents - therapeutic use / Infections / Infectious diseases / Lupus Erythematosus, Systemic / Lupus Erythematosus, Systemic - drug therapy / Lupus Erythematosus, Systemic - immunology / Male / Middle Aged / Original Research / Pandemics / Pre-Exposure Prophylaxis - methods / Prospective Studies / Questionnaires / Regulatory approval / SARS-CoV-2 - immunology / Serology / Severe acute respiratory syndrome coronavirus 2 / Sjogren's Syndrome / Sjogren's Syndrome - drug therapy / Sjogren's Syndrome - immunology / Vaccination / Vaccine Efficacy