Official Title
Seroprevalence of SARS-CoV-2 Infection in Patients With HIV Infection
Brief Summary

As of May 26, 2020, 5,508,904 confirmed cases (145,279 in France) of COVID-19 and 346,508 deaths (28,457 in France) have been reported since December 8, 2019 worldwide. The rapid increase in the number of cases in our territory caused France to pass to level 3 of the epidemic on March 14, 2020. The natural history of this disease is still poorly understood, particularly in patients infected with HIV, patients considered to be at higher risk for severe forms. Knowing the seroprevalence in the population of people living with HIV will make it possible to better understand the Covid infection in immunocompromised patients, know the percentage of immunization and the persistence or not of the antibodies over time, specify the protective nature or not of these antibodies detected.

Detailed Description

To date, very little data is available in HIV-infected patients with Sars-Cov-2 infection.
Only 11 cases of HIV patients with confirmed Sars-Cov-2 infection have been described in the
literature. These patients are under 50 years of age, HIV infection with a controlled viral
load in 8/11, 2 patients with a severe course requiring administration of tociluzumab,
including one patient who died. In addition, the management of these HIV patients is not
codified. Some authors have changed antiretroviral therapy to a protease inhibitor such as
lopinavir or darunavir because of encouraging results in vitro but debated in patients. This
clearly illustrates the disparity of approaches and the lack of data in this patient
population.

Knowing the seroprevalence in the population of people living with HIV will allow us to
better understand the Covid-19 infection in immunocompromised patients, know the percentage
of immunization and the persistence or not of the antibodies over time as well as their
unknown neutralizing effect. until now. No data exist on seroprevalence in the HIV
population.

Serological tests can detect the immune response to COVID-19 in serum. Studies to date have
shown seroconversion typically within two weeks of symptom onset, with notable differences
depending on the studies, techniques and epitopes of the antigens chosen to detect the
antibodies. A study which showed that the seropositivity rate reached 50% on the 11th day and
100% on the 39th day with a seroconversion time of 11, 12 and 14 days in median for the total
antibodies, IgM and IgG.

Diagnosis of SARS-CoV-2 infection is a major public health issue. Serological tests are
currently being developed. Enzyme-linked immunosorbent assay, performed on blood samples, can
be performed in an automated manner and provide an estimate of the level of circulating
antibody.

These serological tests could identify patients who have developed immunity to SARS-CoV-2 and
be useful in the collection of epidemiological data related to COVID-19 or to know the
serological status of exposed persons.

Nevertheless, SARS-CoV-2 is a new emerging virus and the antibody response (quantitative and
qualitative) in COVID-19 patients is largely unknown and that of patients of HIV patients
completely unknown to date. The relevance of the use of serological tests in clinical
practice will indeed depend on the prior availability of physiopathological and clinical
knowledge allowing their interpretation and ensuring adequate indications such as those
recently proposed by the Haute Autorité de Santé ((https: //www.has
-sante.fr/jcms/p_3182370/fr/premieres-indications-pour-les-tests-serologiques-du-covid-19, #
9268)).

Studies to date have shown seroconversion typically within two weeks of symptom onset, with
notable differences depending on the studies, techniques and epitopes of the antigens chosen
to detect the antibodies. A study which showed that the seropositivity rate reached 50% on
the 11th day and 100% on the 39th day with a seroconversion time of 11, 12 and 14 days in
median for the total antibodies, IgM and IgG.

Also, the immune response does not always mean protective immunization against further
infection with the same virus. Only so-called neutralizing antibodies can obtain such
protection. But the titer of neutralizing antibody needed to provide protection is still
unknown for SARS-CoV-2. To date, the target epitopes of neutralizing antibodies have not yet
been identified. In addition, data demonstrating protective immunity against COVID-19 induced
by antibodies produced against SARS-CoV-2 are currently very limited.

A Chinese study that studied the antibody response in 175 patients with mild forms of
COVID-19 found that 30% of them had low neutralizing antibody titer at the end of
hospitalization. Differences in the titer of neutralizing antibodies were observed depending
on the age of the patients, the oldest (40-59 and 60-85 years) having higher titers than the
youngest (15-39 years). The titers remained stable on a control two weeks later (47/175
patients). This study raises the question of the protection of the duration of this
protection.

This is why it is essential to characterize in depth the prevalence of Sars-Cov-2 infection
in patients infected with HIV, patients considered to be at high risk of severe forms, and
the evolution of antibody production according to the evolution of the epidemic and their
protective role over time.

To date, no specific treatment or therapeutic strategy has demonstrated its effectiveness for
COVID-19. Some antiretrovirals such as lopinavir / ritonavir, with in vitro activity on
Sars-Cov-2, have been tested in real life with discordant results. It will be interesting to
look at the antiretroviral treatments of patients who have had a Covid compared to those
seronegative in serology.

Completed
COVID19

Other: Seroprevalence of SARS-CoV-2 infection in patients with HIV infection

On inclusion, after information and collection of the non-objection, a blood sample (D0) will be taken during the assessment of the HIV infection (no unplanned sample will be taken) and a control to determine the appearance or the Persistence of antibodies will be made at M6 and M12 always as part of the assessment of HIV infection.

Eligibility Criteria

Inclusion Criteria:

- Age greater than or equal to 18 years

- HIV + patient followed at the Pitié-Salpêtrière hospital

- Known HIV infection

- Having been informed about the study and having given oral consent (no opposition)

- Beneficiary or entitled to a social security scheme

Exclusion Criteria:

- Refusal of participation by the patient

- Patient subject to a legal protection measure

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

Valérie POURCHER
Paris, Ile De France, France

valérie Pourcher, MD, Principal Investigator
Pitie-Salpetriere Hospital

Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
NCT Number
MeSH Terms
COVID-19