Severe immunodeficiency 'in the eye of the storm'

Severe immunodeficiency ‘in the eye of the storm’

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 who are positive for Covid, will be able to benefit, in some transplant centers, from monoclonal antibody therapy. Exceptionally, the National Medicines Agency (ANSM) has authorized transplant services that have requested, to use the new dual therapy Evusheld (Astra Zeneca) to treat their affected patients, with an extremely high risk of the acute form. In other words, the agency granted “compassionate access” to this preventive treatment, as a treatment, given the “therapeutic predicament” in which severely immunocompromised individuals find themselves, in the midst of the Omicron wave. This treatment option was allowed by the agency because doctors requested it, but this option is not known. I hope ANSM gets in touch soon,” worries Yvanie Caillé, founder of Renaloo, an association for patients with kidney disease.

The mortality rate for immunodeficiency ranges from 15-20%.

For weeks, together with other associations of immunocompromised patients, Renaloo has warned of the lack of specific treatments that today plague this group of patients, who have a mortality rate of 15-20%, in the event of contamination. Organ transplant recipients, some on dialysis, patients treated for blood cancers… There are between 200,000 and 300,000 who do not respond to vaccination, or only respond poorly. Although up to six doses of serum for some. For them, the risks they are exposed to are greater than those of unvaccinated adults, due to their treatments (potent immunosuppressants) and the fragility of their situation. These at-risk patients may be for several weeks unable to access, if infected, treatments able to prevent disease progression. They are in the eye of the storm now.”

New treatments are slow

In fact, monoclonal antibody therapies, which sparked tremendous hope last year, are ineffective against Omicron. Preventive and curative. However, new treatments that are expected to treat those people at very high risk of becoming acutely infected are not available: The first 5,000 doses of Xevuldy (GSK), a pre-active monoclonal antibody on any species, must arrive at the end of January. But the quantities would be “insufficient,” Evani Kayle estimates. As for the antiviral Paxlovid, the anti-Covid treatment from the Pfizer lab, it will be available in February, but it is not yet authorized.

“Over the past 10 days, medical teams have reported a sharp increase in contamination. The founder of Renaloo explains that immunocompromised people protect themselves the most, but the case for parents with young children is the most serious. This is the case of Adrien, 42 , in the Paris region. Heart transplantation and dialysis This dad didn’t go back to school in January and he has two kids aged 5 and 9 There were more and more cases in their classes We even knew the kids were going back to school when he was Their parents have Covid. A ‘complicated’ choice, especially for his 9-year-old daughter, but Adrien is at risk: unresponsive to vaccination and not protected with Evusheld monoclonal antibodies. One study of this new treatment revealed a risk of heart attack. Doctors They are reluctant to give me,” explains this father, who prefers to remain “self-contained” and temporarily withdraw his children from school.

We lack clear information

Before she added: “Access to treatment also depends on which hospital you are in. Fortunately, I was temporarily protected by Ronapreve – ineffective today against Omicron – because I was followed up in two hospitals. One refused and the other allowed me in. Is it a logistical issue For patients, this is hard to accept. I also have a feeling that doctors are a little carried away by sight and they don’t always agree on treatments. We lack clear information.”

Same return from Isabel, 56, near Strasbourg. “My brother and I have a genetic disease. We are both transplanted, we are followed up in different hospitals, and we do not get the same information. This accountant, who has been working from home since the beginning of the health crisis, explains that organizing vaccination is best for people who are less vulnerable than us. She was worried about her adult son The 19-year-old, who received a liver transplant, drives him to high school every day, 25 kilometers from home, wonders: “We always say that immunocompromised people should isolate themselves, but we can do no more than what we are already doing! How do you isolate weak youth? My son had been wearing FFP2 for 18 months as soon as he got out of the car to go to class.”

Hospitalization and exacerbations are rare with Omicron

At the height of pollution, Omicron appears to be less dangerous, including for immunocompromised people. “Hospitalization and exacerbations are more rare than the delta variant, but they are nonetheless present,” identifies Yvanie Caillé, liaison with the hospital’s transplant services. How are these people taken care of today? “Aside from compassionate access to Evusheld, which has just been authorized by ANSM, there is currently no treatment that prevents a serious form, which ancient monoclonal antibodies have allowed. Doctors are reducing anti-rejection therapy to allow the patient to better fight the virus, putting him under Monitoring so that he can interfere with other treatments, should the condition worsen.

We are facing a lack of organization and means

The emergency, for those with severe immunodeficiency, should be protected from infection by Evusheld dual therapy, prescribed in hospital or at home. This is the meaning of the press release issued by the Directorate General of Health, on 4 January, which indicated that “960 patients have been treated, and more than 698 patients are in the process of inclusion.” If today the DGS confirms that “the device should make Evusheld accessible, for patients who need it”, and notes an “overload”, the payoff is very different, on Renaloo’s part. “With an average of 500 requests to get treatment per day, it will take more than two years for all patients to receive a dose. We are facing logistical problems even though giving this treatment is no more complicated than vaccinating. The problem is that the services that track these patients lack nurses and space. And the time. As for the prescription at home, it did not start. Public authorities have been working on prescribing monoclonal antibodies at home for two months, and at the time when it became possible, the price of the act has not been set. So it was completely banned. ” The challenge of protecting these patients with monoclonal antibodies (Evusheld) is also to allow them to restore quality of life, when the virus is quietly spreading. “They will be able to return to work, restore social ties, with protection lasting at least six months. Is it worth it!”

Read also.Covid-19: a permissible treatment in the hope that it will be effective against Omicron

If France was the first country to allow the third dose of the vaccine to these at-risk patients, and the only one in Europe to offer this new preventive treatment, today the founder of the association makes a bitter note: “Due to a lack of resources and organization, hospitals have used monoclonal antibodies very little.” Last year, both preventively and curatively. It’s totally unnatural! This was a real failure for patients who had hoped to finally get protection when a vaccine didn’t work. Today, with Omicron and new treatments, the same problems are emerging again. We haven’t learned from our predicaments. Do we really have, in this health crisis, the will to protect the most vulnerable?

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