The Association of Organizations for Clinical Trials (AOCT), which includes global pharmaceutical companies, has sent a request to the Russian Ministry of Health to exclude hydroxychloroquine, lopinavir and ritonavir from treatment guidelines for coronavirus.
A few days ago, the WHO announced the suspension of these drugs for the treatment of Covid-19. The current recommendations “are not well aligned with the latest data on appropriate treatment options,” according to the AOKI letter, obtained by the BBC.
The Ministry of Health’s manual suggests the use of hydroxychloroquine and its close cousin, mefloquine, which are commonly used to treat rheumatoid arthritis and malaria, including for the prevention of coronavirus. The combination of lopinavir and ritonavir – drugs used to treat HIV infection – is also recommended.
“All of these drugs can be considered to have lost their status as potentially effective in new coronavirus infections according to the results of recent studies,” the association said in the letter.
According to the authors, the U.S. Food and Drug Administration (FDA) has withdrawn approval for the emergency use of hydroxychloroquine and chloroquine to treat coronavirus, and the World Health Organization (WHO) has stopped enrolling patients in the hydroxychloroquine study group.
In the current version of the national methodological recommendations, hydroxychloroquine and the combination of lopinavir-ritonavir are mentioned in 12 out of 16 treatment regimens for mild, moderate and severe forms of the disease caused by the novel coronavirus, according to the letter.
The authors express “extreme concern” that hydroxychloroquine has been widely used by Moscow doctors to prevent coronavirus infection. The prevention program with this drug among them was completed on June 17, the Moscow Health Department reported in response to an inquiry from AOKE.
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“According to the report on the progress of the mentioned “prevention program”, more than four thousand health care workers were exposed to unnecessary risks for several months, based on the current recommendations of the Russian Ministry of Health,” the letter states.
In support of its position, the pharmaceutical company refers to a study that found that “the use of hydroxychloroquine for prevention does not provide any advantages over placebo, but there is a higher probability of adverse events occurring”. Instead of these drugs, AOKI requests that dexamethasone be included in the methodological recommendations.
Dexamethasone is used in the treatment of autoimmune, infectious and rheumatic diseases and is now cited by the WHO as the first drug to show a reduction in mortality in severe Covid-19 patients.
AOKI is a non-commercial organization uniting participants of the Russian clinical trials market. In particular, it includes the largest global pharmaceutical companies Pfizer, AstraZeneca, Bayer and others. In response to an inquiry from the BBC about the letter, the Department of Health clarified that the revision of recommendations “is carried out promptly following the emergence of new scientific data, clinical research results and the registration of new drugs. The working group conducts a comprehensive assessment of the effectiveness and safety of different drugs for different categories of patients, the department noted.
On Saturday, July 4, the WHO announced the suspension of trials of hydroxychloroquine and the combination of lopinavir and ritonavir. This recommendation was made by the International Steering Committee for Solidarity Trials, which was established by the organization to search for effective treatments for hospitalized patients with coronavirus. Hydroxychloroquine and lopinavir/ritonavir appear to have little or no effect on mortality in patients with coronavirus, according to preliminary data.
According to the FDA review released Wednesday, July 1, it states that patients treated with hydroxychloroquine and chloroquine may experience heart rhythm disturbances and other complications related to blood and lymph system disorders, kidney damage, and liver problems.
For the first time, the WHO suspended the study of hydroxychloroquine a month ago. At that time, a study published in The Lancet concluded that the use of hydroxychloroquine was ineffective and could increase the likelihood of patient death. Later, the journal published a rebuttal of the publication, stating that the underlying data were provided by a little-known company, Surgisphere, and were likely incorrect. The WHO then agreed to continue the investigation.
President of the United States Donald Trump talked about taking hydroxychloroquine for preventive purposes. In June, he mentioned that he had taken a two-week course. Hydroxychloroquine is a later and less toxic version of chloroquine and has more pronounced antiviral and anti-inflammatory effects. Chloroquine is commonly used to treat malaria, certain parasitic infections, rheumatoid arthritis, and lupus erythematosus. Both drugs are cardiotoxic and can cause arrhythmias and tachycardia, especially in patients with pre-existing cardiovascular disease, the U.S. Food and Drug Administration warned.