At the heart of the Omicron wave, the most fragile patients are running out of curative treatments.
While they have been the most vulnerable since the start of the health crisis, severely immunocompromised patients, and positive for Covid, will be able to benefit, in certain transplant centers, from treatment with monoclonal antibodies. Exceptionally, the National Medicines Agency (ANSM) has authorized the transplant services that have requested it, to use the new dual therapy Evusheld (Astra Zeneca) to treat their infected patients, at very high risk of severe form. . In other words, the Agency granted “compassionate access” to this prophylactic treatment, as a cure, given the “therapeutic impasse” in which the severely immunocompromised find themselves, in the midst of the Omicron wave. “This therapeutic option has been authorized by the Agency because doctors have requested it, but it is not known. I hope that the ANSM will communicate soon, ”worries Yvanie Caillé, founder of Renaloo, an association of patients on kidney disease.
Immunocompromised mortality is between 15 and 20%
For weeks, with other associations of immunocompromised patients, Renaloo has been warning about the lack of specific treatments which today strikes this population of patients, whose mortality is between 15 and 20%, in the event of contamination. Organ transplant recipients, some on dialysis, patients treated for hematological cancers… there are between 200,000 and 300,000 who do not respond to vaccination, or only weakly. Despite, for some, up to six doses of serum. For them, the risk incurred is greater than that of non-vaccinated adults, due to their treatments (powerful immunosuppressants) and their fragility. “It may be that for several weeks, these vulnerable patients do not have access, if they are contaminated, to therapies capable of preventing the aggravation of the disease. They’re in the eye of the storm right now.”
New therapies are slow
Indeed, monoclonal antibody treatments, which aroused immense hope last year, are ineffective against Omicron. Preventive as well as curative. However, the new therapies expected to treat these people at very high risk of severe form are not available: the first 5,000 doses of Xevuldy (GSK), monoclonal antibodies a priori active on any variant, should arrive at the end of January. But the quantities will be “insufficient”, estimates Yvanie Caillé. As for the antiviral Paxlovid, the anti-Covid treatment from the Pfizer laboratory, it would be available in February, but it is not yet authorized.
“For the past ten days, the medical teams have been reporting a sharp increase in contamination. Immunocompromised people protect themselves more than others, but the situation of parents with young children is the most acute,” explains the founder of Renaloo. This is the case of Adrien, 42, in the Paris region. Heart transplant and dialysis, this father did not return to school in January, his two children, 5 and 9 years old. “There were more and more cases in their classes. We even learned that children were returning to school when their parents had the Covid. A “complicated” choice, especially for his 9-year-old daughter, but Adrien is vulnerable: non-responder to vaccination and not protected by Evusheld monoclonal antibodies. “One of the studies on this new therapy revealed a risk of heart attack. The doctors are reluctant to administer it to me, ”explains this father, who prefers to remain “self-confined” and temporarily withdraw his children from school.
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We lack clear information
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Before adding: “Access to treatment also depends on the hospital where you are. Luckily, I was temporarily protected by Ronapreve – ineffective today against Omicron – because I am followed in two hospitals. One had refused and the other gave me access. Is it a question of logistics? For patients, this is difficult to accept. I also have the feeling that the doctors navigate a little by sight and that they do not always agree on the treatments. We lack clear information.”
Same return from Isabelle, 56, near Strasbourg. “My brother and I have a hereditary disease. We are both transplanted, followed in different hospitals, and we don’t get the same information. I also have the impression that the organization of vaccination is better for people less vulnerable than us, ”explains this accountant, working from home since the start of the health crisis. Worried about her 19-year-old son, a liver transplant recipient, whom she drives to high school every day, 25 km from home, she wonders: “We always say that the immunocompromised must isolate themselves, but we cannot not do more than what we already do! Vulnerable young people, how do you isolate them? My son has been wearing an FFP2 for 18 months as soon as he gets out of the car to go to class.”
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Hospitalizations and aggravations are rarer with Omicron
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At the peak of contamination, Omicron seems less serious, including in immunocompromised people. “Hospitalizations and aggravations are rarer than with the Delta variant, but they nevertheless exist”, specifies Yvanie Caillé, in contact with the transplant services at the hospital. How are these people cared for today? “Apart from compassionate access to Evusheld, just authorized by the ANSM, there is currently no therapy that prevents the occurrence of a serious form, which the old monoclonal antibodies allowed. The doctors lower the anti-rejection treatment of the patient to allow him to better fight against the virus, and place him under surveillance in order to be able to intervene with other treatments, in the event of aggravation.
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We come up against a lack of organization and means
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The emergency, for the severely immunocompromised, is to be protected from infection by the dual therapy Evusheld, prescribed in hospital or at home. This is the meaning of the press release from the General Directorate of Health, on January 4, which indicated that “960 patients were treated and more than 698 were in the process of being included”. If the DGS assures today that “the device must make it possible to give access to Evusheld, to the patients who require it”, and notes “a rise in load”, the return is very different, on the side of Renaloo. “At the rate of 500 requests for access to treatment per day, it will take more than two years for all patients to be able to receive a dose. We come up against logistical problems even though the administration of this treatment is no more complicated than a vaccination. The problem is that the services that follow these patients lack nurses, space and time. As for the prescription at home, it has not started. The public authorities have been working on prescribing monoclonal antibodies at home for two months and, at the time when this is made possible, the pricing for the act has not been established. So it’s completely blocked.” The challenge of protecting these patients with the new monoclonal antibodies (Evusheld) is also to allow them to regain a quality of life, when the virus circulates quietly. “They will be able to return to work, regain social ties, with protection that lasts at least six months. Is it worth it !”
Also read.Covid-19: a treatment authorized in the hope that it will be effective against Omicron
If France was the first country to authorize the 3rd dose of vaccine in these vulnerable patients, and the only one in Europe to offer this new preventive treatment, the founder of the association now makes a bitter observation: “ Due to a lack of resources and organization, hospitals used monoclonal antibodies very little last year, both preventively and curatively. It’s completely abnormal! This was experienced as a real failure for patients who hoped to finally have protection when the vaccine did not work. Today, with Omicron and new therapies, the same problems reappear. We have not learned from our pitfalls. Do we really, in this health crisis, have the will to protect the most vulnerable?
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