impact of long-term protease inhibitors in patients living with hiv on the incidence of covid-19 ( covip )

Conditions: HIV Patients

Summary: this is a prospective multicenter cohort study. the question arises as to whether treatment with protease inhibitors (pis) could have a preventive role for covid-19 infection, especially since patients living with hiv (plwhiv) have not been described as more at risk of developing covid-19 infection. the aim of our study will therefore be to assess the impact of long-term protease inhibitors in plwhiv on the incidence of covid-19.

the symptomatic management of covid-19 infections is currently at the forefront. the therapeutic efficacy of certain molecules is being evaluated in studies, in vitro and in vivo, such as remdesivir, hydroxychloroquine / chloroquine, and lopinavir / ritonavir. the latter has been used in the treatment of hiv for many years, like other pis such as darunavir and atazanavir. in france, around 11% of plwhiv are treated with long-term pis. lopinavir / ritonavir has an inhibitory role on the protein endopeptidase of coronavirus c30 (cep_c30). in humans, cao et al did not demonstrate any superiority of efficacy of lopinavir / ritonavir compared to the control group receiving standard care (hr for clinical improvement: 1.24 (0.90-1, 72)), but the initiation of treatment in the study was mainly at late stages. early initiation of lopinavir/r at the onset of sars symptoms appears to be more effective. to our knowledge, the other pis are under study, with a possible inhibition of the proteases of type-3-chemotrypsin or of the papain type of sars-cov2. three open randomized studies in humans are underway in china, spain, and thailand. the question arises as to whether treatment with pis could have a preventive role for covid-19 infection, especially since plwhiv have not been described as more at risk of developing covid-19 infection. the aim of our study will therefore be to assess the impact of long-term protease inhibitors in plwhiv on the incidence of covid-19. this is a prospective multicenter cohort study. a random sample of 794 eligible individuals will be recruited from april 2020, consisting of 397 patients in the long-term pis group and 397 patients in the long-term arv regimen without pis. the study will be offered to plwhiv in île-de-france, treated with long-term antiretroviral drugs with or without protease inhibitors. for those who accept: i) they will receive phone calls (teleconsultation) to collect information regarding symptoms at m0, m1 and between m3 and m6 by a medical or paramedical person from their hospital center ; ii) in case of a high probability of infection with covid-19, an on-site consultation will be offered to them, with a diagnostic test by pcr on a nasopharyngeal swab and eventually a chest scanner if indicated ; iii) a serology on a blood sample will be performed at the end of the epidemics to look for anti-covid-19 antibodies.

Eligibility criteria:
inclusion criteria: * hiv patients over 18 years of age * follow-up for an hiv infection 1 or 2 * treated with antiretroviral drugs * resident in france during the epidemics * no change in antiretroviral drugs during the epidemics * no-opposition to participate to the research exclusion criteria: * patients under guardianship or curators * opportunistic classifying pathologies by the control disease center (cdc) * patients unable to give a free and informed no-opposition consent to participate to the protocol * patients under safeguarding justice

Keywords: protease inhibitor, antiretroviral drug, covid-19