Coronavirus: slowdown for hydroxychloroquine in France

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The High Council of Public Health (HCSP) on Tuesday issued a negative opinion on the use of hydroxychloroquine, outside clinical trials, whether alone or in combination with an antibiotic. Following this opinion, the French Ministry of Health decided Tuesday, May 27 to ban hydroxychloroquine in the treatment of Covid-19. 

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Could this be the end of the turbulent history of hydroxychloroquine in France? The future of this drug in the treatment of Covid-19 is in any case blocked for the moment. Since Wednesday, it can no longer be prescribed in France . Until then, apart from clinical trials, it could be administered in a strict framework: in the hospital, by collegial decision, under medical supervision and for serious cases of Covid-19. A decree from the Minister of Health therefore ended this possibility. However, the usual indications for the drug (lupus, rheumatoid arthritis in particular) remain authorized. 

This decision follows the opinion of the High Council of Public Health (HCSP), seized by the Minister after the study of the medical journal The Lancet . The HCSP recommends not using hydroxychloroquine or chloroquine in the management of Covid-19, regardless of the severity of the infection, and whether administered alone or in combination with a macrolide - a family of antibiotics to which azithromycin belongs. 

"No proof of profit"

For the HCSP, the current data from the scientific literature "  does not provide proof of a benefit on the evolution of Covid-19  "; the body also considers that there is a cardiac toxicity of hydroxychloroquine, particularly in combination with azithromycin - this is the association ardently defended by professor Didier Raoult. 

The public health organization said it had analyzed international recommendations and publications on the subject, "as  well as reports from regional pharmacovigilance centers reporting potentially serious side effects, particularly cardiovascular, related to the use of this drug.  "

In the process, the National Agency for the Safety of Medicines (ANSM) announced that it would " precautionary  " suspend  clinical trials evaluating hydroxychloroquine. Sixteen trials testing this molecule were underway in France; they will therefore no longer be able to include new patients for the time being. The French agency has aligned itself with the position of the WHO which, a few days earlier, had made a similar decision for the trials it launched with partner countries. The organization will analyze the first data before deciding on the continuation of this work. These opinions and decisions are not irrevocable, they can be modified according to new data. 

One line

The three organizations are on the same line, defended by the vast majority of scientists: only the results of solid randomized trials "  on hydroxychloroquine, associated or not with azithromycin, can provide evidence of its effectiveness and its security,  ”insists ANSM. In other words, to provide such proof, one would need a trial with a significant number of patients, drawn by lot, and where one group receives the treatment to be tested, and the other, a placebo - at an early stage of infection. if we want to evaluate Didier Raoult's protocol. For the moment, no robust clinical trial of this type has been completed and a number are now suspended. 

The study published in the prestigious medical journal The Lancet and which, in addition to previous studies, prompted the three authorities to re-evaluate their directives, is itself a so-called retrospective observational study. The authors analyze the medical data of patients who have been treated. 
The study is very large: more than 96,000 patients, who have been hospitalized in 671 establishments worldwide. The patients were "grouped" according to the drugs taken - chloroquine, hydroxychloroquine, combined or not with an antibiotic of the macrolide family (azithromycin or clarithromycin). Patients receiving only routine care were the control group.

As the groups were not homogeneous (age, risk factors, etc.), the study authors tried to reduce these biases. Their conclusions suggest not only an ineffectiveness of chloroquine, and its derivative hydroxychloroquine, but also an over-risk of cardiac arrhythmia and an over-risk of death. Thus, the mortality rate is 9.3% in the control group, while it is higher in the other groups. It reaches 23% in that of patients treated with hydroxychloroquine and antibiotics. According to the authors, in view of the results, these treatments should not be used outside of clinical trials. 

Note that this is an association, not a cause and effect link, even if previous observational studies go in the same direction and support these conclusions. To prove this link, a randomized clinical trial would be required; this is, moreover, the wish of the authors. This is how we will be able to settle the question definitively, and put an end to the controversy.

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