Drug “Aviewer”, created with the participation of the Russian direct investment FUND will be available to health facilities and will not be available for sale.
the Russian drug for the treatment COVID-19 “Aviewer” working RDIF and a group of companies “Chemrar” will be available in the hospital on 11 June, found “Izvestia”. On 29 may he received a check in the Ministry of health, but research will continue until the end of the summer. The drug in our country placed great hopes — the developers say that its efficiency is above 80%. At the same time in Japan, where it was created based on the original active substance “Favipiravir”, decided to postpone the entry of the drug into circulation, unable to prove the effectiveness of the new tools. In Russia, however, now tested several of his counterparts. In particular, in June in Saransk will start researching more than one such drug — “Araliya”, which is the Foundation — the same “Favipiravir”. Russian virologists keep up with new developments, but opinions about them are ambiguous.
“Favipiravir” was developed in Japan for treatment of influenza and has also been considered as a promising drug for Ebola. In connection with its direct antiviral activity he is now being investigated as a treatment for COVID-19, said the Professor of infectious diseases in children rnsmu. Pirogov, candidate of medical Sciences Ivan Konovalov.
the Ones used by the doctors, have immunomodulatory property — trigger response of the immune reaction. For example, the same aminohinolinovogo derivatives hydroxychloroquine is not intended to treat viral infections, they were synthesized for other purposes — treatment of malaria, some forms of arthritis, explained the Director of the medical Institute of the Mordovian state University Larisa Balykova.
“Favipiravir” was synthesized for the treatment of infections caused by RNA-containing viruses. He showed its effectiveness against influenza viruses, including avian influenza, and other infections. The drug blocks the replication of the virus, which causes severe clinical manifestations of the disease, — said Larisa Balykova.
21 may in 10 regions of the country began the final phase of research of the Russian drug “Aviewer” — analogue “of Favipiravir” working on the Russian direct investment Fund (RDIF) and a group of companies “Chemrar”. “Aviewer” has already received a temporary registration in the Ministry of health — 29 may he included in the state register of medicines for the period until 1 January 2021. Presumably, he will go to the Russian hospital 11 June 2020, said the FUND.
Thus, Russia became one of three countries who have a valid drug against coronavirus (besides the US, entrusting the hope for private development��have a “Ramdevpir”, and Japan, the homeland of “Favipiravir”).
the Decision on the production of domestic Japanese analogue of the drug was based on the positive experience of its use in Asia, said the Deputy Director for postgraduate education and international cooperation Istehsoli biological and medical physics of MIPT Alexander Melerzanov.
the Results of “Avifauna” the registration certificate of the Ministry of health has made Russia the first country in the world where this drug became available for mass use, — said Alexander Melerzanov.
In China a month ago, no one could be found the substance of Favipiravir for any money, now it started to produce dozens of Chinese factories, but this volume continue is not sufficient to cover global demand. In addition there are many questions to quality of raw materials, — told in “Khimrar”.
Clinical studies “of Avifauna” will last until the end of the summer, said “news” in the FUND. The effectiveness of the product is higher than 80%.
At this stage of treatment 65% of patients taking the “Avidavit”, had tested negative for the coronavirus. To 10 day the number of patients with negative test reached 90%.
— Made 18 thousand packages of the drug in June the plan is to put in a Russian hospital over 60 thousand packages. Technological capacity can produce 60 thousand packages a month, 720 thousand packages per year. Thus production capacity can be doubled, if necessary, — told in the FUND.
Investments in the development and production of “Avifauna” account for more than half a billion rubles, approximately half of which is public money, added in the “Khimrar”.
“Aviewer” — not only Russian drug on the basis of “Favipiravir”, on which now employs scientists and doctors. Aware of the development “of Kalivia”, it makes the company “Promomed” factory “Biochemist” in Saransk.
— In the opinion of the community of scientists, this drug may become the main treatment for patients with coronavirus infection.
the Drug we can get in June, — told “Izvestia” chief urologist of Ministry of health of the Russian Federation Dmitry Pushkar, who is responsible for the implementation of the Protocol studies of the drug in Russia.
the Study on “Araliya” comes in five regions of Russia, said Larisa Balykova. In particular, they will be held in the medical Institute of Mordovia state University, which she chaired.
— the Tests in our Institute will start within days. Now everything is ready to open the research center. But I don’t think one drug we will solve the problem. The virus is very tricky, rapidly mutate. To guarantee that we have enough of one drug, it is not necessary, — concluded L��rice Balykova.
the FUND is called the possible causes of the discrepancies in the results of studies of racial or genetic approaches to treatment at different stages and in different dosages.
the makers of the drug also claim that “Aviewer” more effective than the American “Redecision”, which is also able to stop the multiplication of viruses. “Aviewer” faster kills the virus in the body (4-5 days vs 11 days in “Ramdevpir”), if it is applied twice reduced percentage of mortality and four times fewer serious adverse events than using American competitor.
the Impact of the drug on the virus SARS-CoV-2 — the question is still open, believe the doctors.
Different studies show contradictory results. Its use may be limited for certain groups. In particular, it has teratogenic effect — contraindicated in pregnant women, — said Ivan Konovalov.
— for Example, drugs based on hydroxychloroquine for malaria is usually satisfactorily tolerated, whereas COVID-19 may worsen the prognosis of patients in critical condition. Also essential regimen — the dose and duration used drugs — said Ivan Konovalov.
in addition, research in one country can not justify automatic inclusion of the drug in protocols for treatment in another country. Although, of course, in a pandemic, the timing of such studies and recording of results can be accelerated. So, in China and Italy tested the “Favipiravir” when COVID-19 was held in March, concluded Ivan Konovalov.
Meanwhile, a drug that the United States presented to the world as a cure No. 1 from the coronavirus, it seems, does not justify the hopes placed in him. Clinical trials of “Ramdevpir” I stopped, not waiting for the final results. But experts the U.S. National Institute of Allergy and infectious diseases (NIAID) stated: the experiment was terminated to prevent unnecessary casualties among the patients in the control group who received a placebo. The scientists found that the drug is so promising and effective, it is impermissible to give people involved in the study, “pacifier”.
But Russian scientists are skeptical about such statements. The Deputy Director on scientific work of IFHE RAS Oleg Batishchev told “Izvestia” that this case will require additional proceedings in the future.
That is the clinical effectiveness of “Ramdevpir” continue not proven. However, there is evidence that the drug is not working. So in the leading scientific journal the Lancet published an article by a Chinese author groups, which examines the effectiveness of “Ramdevpir” in the group of patients hospitalized with coronavirus pneumonia in the period from 6 February to 12 of March 2020. The experiment involved 237 patients (158 received medication, and 79 placebo). “In this study “Ramdevpir” was not associated with statistically significant clinical benefits,” noted the publication.
the Study showed that “Ramdevpir” has no effect on reducing mortality from COVID-19 — said infectious disease physician, employee clinical research MHZ of the Department of AIDS and International center of Virology peoples ‘ friendship University (HEI participating in the project “5-100”) Yelena Belova.
As explained by the “Izvestia” the head of the laboratory of genomic engineering MIPT Pavel Volchkov, professionals have long understood that this drug will not work against coronavirus. Initially the “Ramdevpir” was developed for other purposes: as a remedy against Ebola and other viruses. But it is not designed for therapy COVID-19.
