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.
Other: No intervention
No intervention: Usual care for nasopharyngeal sampling and blood sampling for COVID-19 detection
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
CHI Créteil
Créteil, France
CHU Henri Mondor
Créteil, France
Centre hospitalier de Melun (GHSIF)
Melun, France
Hopital universitaire de Hotel Dieu
Paris, France
Hopital Universitaire de Necker
Paris, France
CHI Villeneuve St Georges
Villeneuve-Saint-Georges, France